PROJECT REPORT - Environmental Clearance

M/s VPL Chemicals Pvt. Ltd. Pre-Feasibility Report

i

PROJECT REPORT On

EXPANSION/MODIFICATION OF APIs MANUFACTURING INDUSTRY

At

Plot No. 64, Sompura Industrial Area, Dabaspet, Nelamangala Taluk, Tumkur Road, Bangalore,

Karnataka

For

M/s. VPL CHEMICALS PVT. LTD., #27, Behind “The Club”

Nayandahalli, Mysore Road, Bangalore

Environmental Consultants

M/s. AQUA TECH ENVIRO ENGINEERS, (Environmental Engineers & Consultants) # 3391, 6th Main, 3rd Cross, RPC Layout,

Vijayanagar II Stage, Bangalore – 560 040

Tele Phone : 080 23141679 E-mail: [email protected]

2016

mailto:[email protected]


ii

Contents

Sl. No. Description Pg. no

1 CHAPTER 1-EXECUTIVE SUMMARY 1-14

2 CHAPTER 2- INTRODUCTION OF THE PROJECT/ BACKGROUND INFORMATION

15

2.1 Introduction of project proponent 15

2.2 Brief description about the nature of the project 16

2.3 Need for the project and its importance to the country and/ region

16

2.4 Demand supply gap, imports vs ingredients production 18

2.5 Expert possibility 18

2.6 Domestic/Export Markets 18

2.7 Employment generation due to the project 18

3 CHAPTER 3- PROJECT DESCRIPTION

3.1 Type of project 19

3.2 Location of the industry 19

3.3 Basis of selection the site 20

3.4 Size/ magnitude of operation 21

3.5 Products manufactured 21

3.5.1 Fexofenadine HCl 21

3.5.2 Ambroxol HCl 27

3.5.3 Amlodipine Besylate 31

3.5.4 Fluconazole 36

3.5.5 Febuxostat 40

3.5.6 Pregabalin 43

3.5.7 Dabigetran 48

3.5.8 Verapamil HCl 51

3.5.9 Terfenadine 54

3.6 Raw materials 59

3.6.1 Storage facility for raw materials and products 62

3.6.2 Machinery and equipment details 63

3.7 Resource optimization/ recycling and reuse envisaged in the project

65

3.7.1 Solvent recovery and reuse 65

3.7.2 Solvent Recovery System 66

3.8 Hazardous Raw Materials Used In The Manufacturing Process

66

3.8.1 Hazardous waste generation and its management during the manufacturing process

67

3.8.2 Hazardous Waste Quantity and Disposal Details 68

3.9 Domestic solid waste reuse 68

3.10 Water, energy/ power requirement and source 68

3.10.1 Water 68

3.10.2 Power 68

3.11 Wastes generated and scheme for their management/ disposal

68

3.11.1 Water demand and wastewater/ effluent discharge 68


iii

3.12 Product wise water consumption and discharge 70

3.12.1 Waste Water Characteristics 70

3.12.2 Treatment Scheme for Industry Waste Water 71

3.13 Air pollution sources 73

3.13.1 Scrubbing System Details 73

3.14 Noise generation and its management 74

3.15 Solid waste generation and management 74

3.16 Schematic representations of the feasibility drawing 75

4 CHAPTER 4- SITE ANALYSIS

4.1 Connectivity 76

4.2 Land form, land use and ownership 76

4.3 Topography 77

4.4 Existing land use pattern 77

4.5 Existing infrastructure 78

4.6 Soil Classification 78

4.7 Climatic Data From Secondary Sources 78

4.7.1 Temperature 78

4.7.2 Relative Humidity 79

4.7.3 Rainfall 79

4.7.4 Atmospheric Pressure 79

4.7.5 Inversion height 79

4.7.6 Cloud Cover 80

4.7.7 Wind 80

4.8 Social infrastructure available 80

5 CHAPTER 5- PLANNING BRIEF 85

5.1 Planning concept 85

5.2 Population projection 85

5.3 Land use planning 85

5.4 Assessment of infrastructure demand 85

5.4.1 Water supply and sewerage infrastructure 85

5.5 Amenities/Facilities 85

6 CHAPTER 6- PROPOSED INFRASTRUCTURE 86

6.1 Industrial area (processing area) 86

6.2 Residential Area (Non Processing Area) 86

6.3 Green belt 86

6.4 Social infrastructure 86

6.5 Connectivity 86

6.6 Sewerage system 86

6.7 Industrial waste management 86

6.8 Solid waste management 86

6.9 Power requirement and supply source 87

7 CHAPTER 7- REHABILITATION & RESETTLEMENT PLAN 87

8 CHAPTER 8- PROJECT SCHEDULE & COST ESTIMATES 87

8.1 Time schedule 87

8.2 Estimate project cost 87

9 CHAPTER 9- ANALYSIS OF PROPOSAL 88


iv

List of tables

Table no.

Description Pg. no

3.1 APIs are proposed to be manufactured 21

3.2 Raw materials requirement 59

3.3 Details of storage facilities 62

3.4 List of the machinery and equipments 63

3.5 Solvent recovery 65

3.6 Hazardous raw materials 66

3.7 Quantity of process residue generation from solvent recovery and Carbon waste generated from manufacturing process

67

3.8 Hazardous Waste Quantity and Disposal Details 68

3.9 Water Consumption and Discharge

69

3.10 Sewage/effluent treatment and discharge

69 3.11 Product-wise water consumption for process and effluent

discharge

70

3.12 Waste Water Characteristics

70 3.13 Air pollution sources, fuel consumption and chimney height

details 73

3.14 Solid waste generation 74

4.1 Connectivity from the project site 76

4.2 Existing land use pattern 77

4.3 Meteorological Data of Bangalore for the Year 2015 78

4.4 List of Infrastructural Facilities in the Surroundings 80

5.1 Land use pattern 85

List of figures

Fig. No.

Description Pg. no

3.1 Google Map Showing Project Site 19

3.2 Map showing the Project Site Location on District Map of Bangalore

20

3.3 Water balance chart 72

3.4 Scrubbing System 74

4.1 Google map showing connectivity 76

4.2 Topo Map 77

4.3 Wind rose diagrams 81


v

M/s VPL Chemicals Pvt. Ltd. Project Report

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Chapter-1

EXECUTIVE SUMMARY

1.1 INTRODUCTION

1.1.1 Preamble

Amendment of the Environmental Impact Notification No. S.O. 60(E) dated

27.01.1994, issued by the MoEF, Govt. of India has made mandatory under Schedule-

I of EIA notification for 30 different activities to obtain NOC (No Objection

Certificate) from the State Pollution Control Board and Environmental Clearance

from the Ministry of Environment & Forests, Govt. of India. This amendment to the

EIA Notification is effective from 14.09.2006.

As per the amended EIA notification dated 14th September, 2006 the API

manufacturing industry will fall under category B schedule 5(f). The proposed

project is Expansion/Modification of API manufacturing.

The proposed expansion and modifications envisages deletion of some of the existing

and addition of some product, which will be manufactured within the existing

manufacturing facilities. The effluent quality and quantity generation will

marginally increase with 5 to 10 % which will be treated in the existing Zero

Discharge Plant (ZDP) having an adequate capacity of 600 liters/hour. There is no

additional process emissions except thermic fluid heater boiler, which has an

adequate stack height. Existing Zero Discharge Plant (ZDP).

M/s. VPL Chemicals Pvt.Ltd., #27, Behind “The Club” Nayandahalli, Mysore Road,

Bangalore-560039, intends to Expand and Modify the existing Active Pharmaceutical

Ingredients (APIs) manufacturing industry at Plot No. 64, Sompura Industrial Area,

Dabaspet, Nelamangala Taluk, Tumkur Road, Bangalore, Karnataka.

The present APIs manufactured are provided under Table 1.1

Table 1.1 Present API manufactured

APIs & Intermediates Production capacity (kg/annum)

Amyl meta cresol 600

Benazepril Hydrochloride 600

Fexofenadine hydrochloride 1200

Ambroxol hydrochloride 6000

Oxcarbazepine 1200

P-nitrobenzene sulfonyl chloride

1200

2,4- Dichlorobenzyl alcohol 16800


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Table 1.2 The Proposed APIs to be manufactured

Sl. No.

APIs Existing production capacity(Kg/Month)

Production capacity (kg/month)

Nature/ Type of product

1 Fexofenadine HCl 100 4500 ( After Expansion)

All products are API’s

2 Ambroxol HCl 500 4500 ( After Expansion)

3 Amlodipine Besylate

New Products

4500

4 Fluconazole 4500

5 Febuxostat 1000

6 Pregabalin 3000

7 Dabigetran 3000

8 Verapamil HCl 3000

9 Terfenadine 3000

1.1.2 Project at Glance

Sl.No. Details

1 Project Expansion and modification of Active Pharmaceutical Ingredients (APIs) manufacturing industry – “M/s. VPL Chemicals Pvt. Ltd.,”

2 Project developers

M/s. VPL Chemicals Pvt. Ltd., # 27, Behind “The Club” Nayandahalli, Mysore Road, Bangalore-560039

3 Location of the site

Plot no. 64, Sompura Industrial area, dabaspet, Nelamangala Taluk, Tumkur Road, Bangalore

4 Constitution of the Organization

Private Limited Company

5 Raw materials Details of the raw materials required by the industry is appended in Section 3.6. Chapter 3 of this report.

6 Product/s proposed to be manufactured with production capacities? #

The following APIs are proposed to be manufactured

Sl. No.

APIs Production capacity

(kg/month)

Nature/ Type of product

1 Fexofenadine HCl 4500

All products are API’s

2 Ambroxol HCl 4500


4500

4 Fluconazole 4500

5 Febuxostat 1000

6 Pregabalin 3000

7 Dabigatran 3000


9 Terfenadine 3000

7 Project cost? For expansion Proposal 8 Lakhs


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8 Total man power requirement during construction

phase occupancy

phase

Construction phase: No construction activity Operational phase: 50 employees.

9 Proposed trees to be planted?

Tress planted – 50 nos Trees proposed to be planted- 50 nos

10 Species of trees to be planted?

Silver Wood, Teak wood, Coconut, Asoka Trees, Mango trees, Cassia fistula, Alstonia scholaris, and several native species

11 Rain water harvesting tank details?

30 KLD Capacity

12 Groundwater recharging pits details?

Storm water recharge pits are provided

13 Elevation of the project site with respect to MSL?

933 m above MSL; Latitude: 13°13’'29.51"N; Longitude: 77°15'55.85"E

14 Total area of the project?

5058.57 SQM (about 1.25 Acres)

15 Ground water quality?

Portability of water is tested and can be used for drinking.

16 Noise levels? Noise levels are within the standard limits.

17 Facilities provided for the workers during construction phase at site?

1. Adequate potable drinking water supply 2. Septic tank and soak pit facility for treating wastewater generated from the workers.

1.1.3 Water Requirement and Wastewater Treatment and Discharge Details

Sl. No.

Particulars Details

A Water, wastewater details

1 Water supply sources Bore well water supply

2 Total water requirement 6.5 KLD

3 Total wastewater generated

13.6 KLD (11.8 KLD effluent + 1.8 KLD Domestic)

4 Treatment/Disposal details

Effluent Treatment Plant (ETP) with Multiple Effect Evaporator (MEE) followed by RO Filtration.

B Air pollution details

1 Sources of air pollution Process sections, Boiler, DG set


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2 Air pollution control units provided

* Packed column scrubbers for process sections with Chimney height of 15 m above RL. * DG set stack height as per the stack height calculation for 250 kVA is 12 m AGL and 15 kVA(proposed) 3m AGL * For agro based fuel boiler for 2 Ton and 1 Ton (proposed) combined stack height of 30.48 m above GL and with Mechanical dust collector. * Thermic Fluid Heater (TFH) of stack 10 m will be provided C Solid/Hazardous wastes

1 Source of solid waste Domestic sources and Manufacturing process.

2 Total quantity of solid waste generated

Domestic solid waste – 3750 kg/annum Hazardous solid waste

Sl. no

Hazardous waste

Quantity kg/annum

Category

1 Residue from the manufacturing process

3,70,344 28.1

2 Spent Carbon 7,644 28.2

3 Waste oil generation from DG set

200 5.1

4 Inorganic salt from MEE.

52,800 34.3

3 Treatment/Disposal of solid wastes

* The domestic wastes are segregated at source and collected in bins. The organic portion of the solid wastes will be composted and recyclable portion will be disposed to the recycler for scientific recycling. * The disposal for various types of generated hazardous waste handling and management is detailed in Chapter 3, Section 3.8.2 of this report.


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1.1.4 Water Requirement and Wastewater Treatment and Discharge Details I) Quantity of Water Required and Wastewater Generated The total quantity of water requirement for the industry is about 6 KLD. The break-up of the consumption of water is as presented in Table 1.3.

Table 1.3 Water Consumption and Discharge

Water consumed for Consumption (LPD)

Discharge (LPD)

(a) Domestic (toilet, canteen etc.) 2000 1800

(b) Gardening/Landscape development

350 -

(c) Industrial purpose

Process

1. RO plant and its reject 7200-5513=1687 (reject)

8873 (process effluent + Rejects) a. Process consumption 5513

2. Washing/Cleaning 1500 1500

3. Boiler feed for 2 MT boiler 3000 100 (Blow down)+ DM reject 600 a. DM plant/rejects 600

4. Cooling tower – 2 nos. 1000-800 (Condensate)= 200 (make up water)

20

5. Scrubber – 1 no. 500 500

6. R & D 150 150

Total 16300 13543 or say 13600KLD

Note:

LPD = L/day; KLD = kilo liter/day. At any given time only one product will be manufactured. The excess quantity of process effluent generated is due to the reactions

taking place during the manufacturing process. Startup water requirement for industrial purpose is 13950. After recycling of

Evaporator condensate the fresh water requirement will be 4000 LPD.

ii) WASTEWATER TREATMENT AND DISPOSAL DETAILS

The treatment methods and the final disposal of each type of wastewater generated

is appended in the table 1.4

Table 1.4 Sewage/wastewater treatment and discharge

Sewage/effluent generated from

Treatment provided Final disposal point

(a) Domestic Sewage is treated septic tank Disposed in Soak pit

(b) Industrial Full-fledged ETP with collection tanks of 10 KL capacity (4 no.s) are provided.

Industrial effluent is treated in Effluent Treatment Plant (ETP) with Multiple Effective Evaporator (MEE) followed by RO filtration for treatment, reuse.


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1.1.5 Raw Materials The raw materials required for the manufacture of APIs are appended in the table 1.5 below. Raw materials as listed will be procured as per the production requirement.

Table -1.5 Raw Materials Requirement for manufacture of API Sl. No.

Product Raw materials Quantity required Solvents required after

recycling kg/annum

kg/batch kg/month kg/annum

1 Fexofenadine HCL

Methyl (Stage1) 273 4095 49140 -

Azacylonol 231 3465 41580 -

Potassium iodide

3 45 540 -

Sodium bi carbonate

117 1755 21060 -

Sodium Boro hydride

30 450 5400 -

Sodium hydroxide flakes

66 990 11880 -

HCL 300 3285 39420 -

methyl iso butyl ketone

1092 16380 196560 -

Hyflow 3 45 540 -

Activated Carbon

3 45 540 -

Purified water(stage 1)

681 10215 122580 -

Stage 2 138 2070 24840 -

Methanol(stage 2)

1089 16335 196020 19440

Stage 3 165 2475 29700 2700

Ethyl acetate 324 4860 58320 5400

Iso propyl alcohol

165 2475 29700 2700

2 Ambroxol HCL

2-amino-3,5-Dibromo Benzaldehyde

216 3240 38880 -

Trans 4-aminocyclohexnol

90 1350 16200 -

Sodium Borohydride

30 450 5400 -

Activated carbon

6 90 1080 -

Hy flow 3 45 540 -

HCL 54 810 9720 -

Purified water 765 11475 137700 -

Acetone 1800 27000 324000 25920


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Methanol (Stage I)

1224 18360 220320 22140

3 Amlodipine besylate

Monomethylamine

786 11790 141480 -

Phathoylamlodipine

321 4815 57780 -

Benzene sulphonic acid

129 1935 23220 -

Activated charcoal

6 90 1080 -

Hy flow supercell

6 90 1080 -

Purified water (stage 1)

621 9315 111780 -

Stage 2 735 11025 132300 -

Methanol 1743 26145 313740 3240

Ethyl acetate 1743 26145 313740 1080

4 fluconazole Di-floro-tetra-aceto-phenone

348 5220 62640

Trimethyl solfoxonium iodide

156 2340 28080

1,2,4 triazole 156 2340 28080

Potassium hydroxide

225 3375 40500

HCL 249 3735 44820

Hyflow supercell

6 90 1080

Citric acid 9 135 1620

Purified water 870 13050 156600

Toulene 117 1755 21060 2700

5 Febuxostat Ethyl-2-(3-cyano-4-isobutoxyphenyl)-4-methyl-5-thiazolecarboxylate

153 1530 18360

Febuxostat crude

130 1300 15600

NAOH 23 230 2760

HCL 62 620 7440

Acetone 1333.8 13338 160056 8004

Isopropyl alcohol

600 6000 72000 3540

Activated carbon

6 60 720

Celite 6 60 720


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Water 3401 34010 408120

6 Pregabalin R-(-)-3- carbamoymethyl hexanoic acid

504 5040 60480

Hydrochloric acid

708 7080 84960

Sodium Hydroxide

330 3300 39600


Isopropyl alcohol

1413 14130 169560 7560

7 Dabigetran 3-[(1-Methyl-2-

{[4-(5-oxo-4,5-

dihydro-

[1,2,4]oxadiazol

-3-yl)-

phenylamino]-

methyl)-1H

benzoimidazole-

5- carbonyl)-

pyridin-2-yl-

amino]-

propionic acid

ethyl ester

15 150 1800

P-toluene sulphonic acid

4 40 480

Acetic acid 3 30 360

IPA 375 3750 45000

Hexa

chlorofomate

4 40 480

Acetone 180 1800 21600

Potassium

Hydroxide

2 20 240

Hydrochloric

acid

0.1 10 120

Water 150 1500 18000

8 Verapamil HCL

2-(3,4- Dimethoxyphenyl)-3-methylbutanenitrile

324 3240 38880

N-(3-choloropropyl)-N-[2-(3,4-dimethoxyphenyl)ethyl]-N-methylamine

225 2250 27000

Sodamide 48 480 5760


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HCL 183 1830 21960

Activated carbon

3 30 360

Hyflow supercell

6 60 720

Toluene (stage 1 )

2163 21630 259560 9740

Stage 2 1686 16860 202320 1440

RO water 1050 10500 126000

Methanol 804 8040 96480

9 Terfenadine 1-(4-tert-butyl phenyl)-4-chloro-1-butanone

273 2730 32760

Azacyclanol 231 2310 27720

Potassium Iodide

3 30 360

Sodium bi carbonate

117 1170 14040

Sodium boro hydride

30 300 3600

HCL 138 1380 16560


Methanol 1347 13470 161640 3600

Ethyl Acetate 324 3240 38880 8280

* At any given time only one or two products shall be made

1.1.6 Solvent Recovery and Recycling

Various solvents will be used during the manufacturing process. The solvents proposed to be recovered and recycled during the process of recovering the solvent of such product are detailed in table 1.6 below.

Table 1.6 Solvent Recovery

Sl.No

Product Raw materials Quantity (kg/annum)

Recovered and recycled

Lost

1 Fexofenadine HCL Stage 1

Ethyl acetate 52920 5400

Stage 2 Methanol 176580 19440

Stage 3 Iso propyl alcohol 27000 2700

Methanol 27000 2700

Methyl iso butyl ketone

186840 9720

2 Ambroxol HCL Stage 1

Methanol 198180 22140


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Stage 2 Acetone 298080 25920

3 Amlodipine besylate Stage 3

Methanol 310500 3240


4 fluconazole Toluene 18360 2700

5 Febuxostat Iso propyl alcohol 68460 3600

Acetone 152052 8004

6 Pregabalin Stage 3

Iso propyl alcohol 162000 7560

7 Dabigetran Iso propyl alcohol 44100 227

Acetone 6897.6 432

8 Verapamil HCL Stage 1

Toluene 249840 9720

Stage 2 Toluene 200880 1800

9 Terfenadine Ethyl acetate 35280 3600


1.1.7 Air Pollution Details

The major air pollution sources from the industry are DG set, boiler and process sections. These sources are provided with stacks of adequate height so as to disperse the emanating flue gases containing SPM, oxides of sulfur and nitrogen without affecting the ground level concentrations and packed column scrubbers are provided to the process sections with adequate stack height as per the regulatory requirements.

The sources of air pollution, type of fuel used, fuel consumption and chimney heights for each of the air pollution sources of the proposed project are indicated in the following table 1.7.

Table 1.7 Sources of air pollution, type of fuel used, APC details

SI. no.

Stack attached to

Fuel used Fuel consumption

Number of

stacks

Stack/s height

Air pollution control unit

Predicted emissions

1 Process section

- - 1 15 m ARL

Packed column scrubber – 1 no.

Acid mist/ VOCs

2 Steam boiler –2 Ton capacity – 1 no.s

Briquette 163 Kg/hr

82 Kg/hr

1 combined stack

30.48 m AGL

Mechanical dust collector

SO2, NOx, SPM


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1 ton capacity 1 no (proposed)

3 Thermic Fluid Heater (Proposed)

Briquette 75 Kgs/hr 1 10m AGL

Stack SOx, NOx, SPM

4 D.G. set – 250 kVA – 1 no.

15 kVA- 1 no (proposed)

HSD 58.75 L/hr

3 .5 L/hr

1

1

5 m AGL

3m AGL

Stack SOx, NOx, SPM

1.1.8 Noise pollution details The major source of noise pollution in the industry is the DG set for which acoustic enclosure is provided. Also ambient noise levels will be ensured within the ambient standards by inbuilt design of mechanical equipment and building apart from vegetation (tree plantations) along the periphery and at various locations within the industry premises. 1.1.9 Solid waste details The quantity of solid waste generated from the proposed industry is detailed in the following table 1.8.

Table: 1.8 Solid Waste Generation during the Operation Phase

Total no. of employees 50

Assuming per capita solid waste generation rate as 0.25 kg/capita/day

Quantity of solid waste generated 12.5 kg/day

Organic solid waste : 60 % of the total waste 7.5 kg/day

Inorganic solid waste : 40 % of the total waste 5 kg/day

Disposal of domestic solid waste The domestic wastes are segregated at source, collected in bins and composted.

1.1.10 Hazardous Raw Materials Used in the Manufacturing Process

The following raw materials used during the process of manufacture of APIs are hazardous in nature according to Manufacture, Storage and Import of Hazardous Chemical (Amendment) Rules, 19th January 2000, Schedule I, Part II in the table 1.9


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Table: 1.9 Hazardous raw materials

Hazardous raw material Sl. No. as per Manufacture, Storage and Import of Hazardous Chemical (Amendment) Rules, 19th January 2000, Schedule I, Part II

Hydrochloric acid 313

Ethanol 248

Sodium Hydroxide 571

Potassium hydroxide 522

Methanol 377

Toluene 628

Iso Propyl Alcohol 334

Formaldehyde 295

Dimethyl Amine 215

Acetone 4

Chloroacetyl Chloride 124

Methylene chloride 400

1.1.11 Hazardous Waste Generation and Its Management during the Manufacturing Process

The hazardous wastes generated during the process of manufacture of different APIs

are stored at hazardous waste storage area and sent to authorize processers. The

quantities of hazardous waste generated from various processes are shown in the

following tables 1.10.

1) Solvent Residue and Spent Carbon

Table: 1.10 Quantity of process residue generation from solvent recovery and

Carbon waste generated from manufacturing process

Sl. No.

APIs Quantity of hazardous waste generated, kg/annum

Spent Carbon waste generated, kg/annum

1 Fexofenadine HCl Stage 1

25380 -

Stage 2 23760 -

Stage 3 17820 -

2 Ambroxol HCl Stage 1

17820 -

Stage 2 18360 1080

3 Amlodipine Besylate 11880 1080

4 Fluconazole stage 1 64260

Stage 2 16200 3240

5 Febuxostat 3468

Stage 2 4404 2244

6 Pregabalin Stage 1 8172 -

Stage 2 16560 -

7 Dabigatran 34200 -


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Stage 2 26700 -

8 Verapamil HCl stage 1

38520 -

Stage 2 7200 -

9 Terfenadine 16920 -

Stage 2 18720 -

TOTAL 3,70,344 7,644


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Table 1.11 Environmental Management Plan during Operation Phase

Sl. no.

Environmental components

Predicted impacts

Probable source of impact

Mitigation measures Remarks

1 Ambient air quality

Minor negative impact.

Process of manufacture of APIs

Particulate and gaseous emissions from DG set and boiler

Vehicular Movement

Manufacturing process involves closed operations in various controlled reactors.

The process area is provided with abundant natural light and ventilation and high roofs to disperse the fumes/gases to the outside atmosphere; preventing the increase of ground level concentrations (GLC’S) as it gets dispersed.

Packed column scrubbers are installed to neutralize and control dust and fumes from the process section.

The treated waste gases and fumes will be let out through adequate stack height.

The emissions from DG & boiler will be let out through adequate stacks height

Orderly Movement of Vehicles will done in the premises.

The roads are made of tar and regularly water sprinkling will be done to control fugitive emissions.

DG sets will be used only during power failure.

2 Noise Minor negative impact near noise generation sources inside the premises.

Operation of machineries during the manufacturing process.

Handling and conveying of raw

The conveying system shall be maintained by following routine and periodic maintenance to reduce noise generation in material handling.

-


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materials and semi-finished components to different areas of operations

Operation of DG set.

DG set with prebuilt acoustic enclosure as per CPCB norms is installed in dedicated utility area, where the access will be restricted. Also the use of PPE (ear plugs) will be mandatory in this area.

Green belt at the project boundary will act as noise barrier and help in attenuation of noise.

3 Water quality No significant adverse impact

Discharge of and industrial effluent

Domestic sewage treated in septic tank and soak pit.

The industrial effluent is proposed to be treated in an Effluent Treatment Plant (ETP) with Multiple Effect Evaporator (MEE) followed by RO Filtration for treatment, reuse and disposal.

Water conservation measures will be encouraged.

4 Land No negative impact

Discharge of wastewater.

Storage and disposal of solid wastes.

Domestic sewage will be treated in septic and sent to soak pit The industrial effluent is treated in Effluent Treatment Plant (ETP) with Multiple Effect Evaporator followed by RO Filtration for treatment, reuse and disposal.

-

5 Socio-economic Overall positive impact

Employment opportunities

Locally available man power will be utilized to the maximum possible extent.

-


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Chapter-2 INTRODUCTION OF THE PROJECT/BACKGROUND INFORMATION

2.1 INTRODUCTION OF PROJECT PROPONENT M/s VPL Chemicals Pvt. Ltd. having registered office at # 27, Behind “The Club”

Nayandahalli, Mysore road, Bangalore have established API’s manufacturing industry

at plot no 64, Sompura Industrial Area, Dabaspet, Nelamangala Taluk, Tumkur Road,

Bangalore. Now M/s VPL Chemicals Pvt. Ltd intend to expand and modify the API’s

in the existing facility.

Mr. Patil Shashidhar Gowd S/o Veerana Gowda Patil is aged about 46 years is a young,

dynamic entrepreneur. He is a Post–Graduate (M.Com) and also completed the

intermediate in Chartered Accountants Course (ICAI). He is quite conversant with

the corporate financial matters and corporate laws. Before being taken over the

charge of Managing Director of VPL Chemicals Pvt. Ltd, he has served in many

reputed organizations and acquired good knowledge on financial and management

of accounts. He is very conversant with corporate affairs and travelled widely

abroad. Apart from overall corporate matters, personally taking care of taking care

of Accounts & Finances and Human Resources Department.

Mr.Sreedhar G. Patil:

Mr. Shridhar G. Patil S/o Veerana Gowda Patil is aged about 45 years. He has

completed his Master degree (M.Sc. in Chemistry) with 1st Rank and recipient of Gold

Medal from Gulbarga University. With research bent of mind, he joined Indian

Institute of Science (IISc), Bangalore, as Research Scholar. He has secured funding

from TEPP from Dept. of Science and Technology from Govt of India on his

independent capacity on the project titled design and development of Temperature

Indicating chalks. Mr. Shridhar could successfully completed the research project

by developing more than 200 formulations and commercialized the developed

technology. He has also developed Temperature Indicating Labels/strips very first

time in India and successfully commercialized the technology. He has also exposed

to bulk drugs R & D and manufacturing processes and travelling widely abroad.

Presently he is on the Board of Directors in VPL Chemicals Pvt. Ltd. His current

responsibilities include overall in charge of Production, Sourcing of raw Materials,

Quality Control and R & D departments apart from rendering technical services to

the company.


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Dr. Yerriswamy Pateel

Dr. Yerriswamy Pateel S/o Veerana Gowda Patil is aged about 43 years has

completed his Master degree (M.Tech. in Mineral Processing) with 1st Rank and he

was recipient of Gold Medal from Gulbarga University. Acquired Ph.D. Degree on

Coal Beneficiation from Barkatullah (Bhopal) University in the year 2001. He has

published more than 25 research papers in National, International Journals,

Conferences, and Seminar proceedings. Before joining VPL Chemicals Pvt. Ltd, he

has served for various institutes and industries. Dr. Pateel has widely traveled in

India and abroad and acquired basic knowledge international marketing. He is

currently one of the Board of Directors of VPL Chemicals Pvt. Ltd. His current

responsibilities include managing of marketing activities and successful

commercialization of the newly developed technologies apart from developing new

business alliances. Also taking care of Quality Assurance Department.

2.2 BRIEF DESCRIPTION ABOUT THE NATURE OF THE PROJECT

M/s VPL Chemicals Pvt. Ltd. Is a private limited company with Shri. Shashidhar G

Patil as Managing Director have already established API’s manufacturing industry at

plot no 64, Sompura Industrial Area, Dabaspet, Nelamangala Taluk, Tumkur Road,

Bangalore. Now M/s VPL Chemicals Pvt. Ltd intend to expand and modify the existing

API’s in the existing facility.

An active ingredient (AI) is the substance of a pharmaceutical drug that is biologically active. Terms in similar use include: active pharmaceutical ingredient (API) and bulk active in medicine. Some medications may contain more than one active ingredient. The traditional word for the API is pharmacon or pharmakon which originally denoted a magical substance or drug. A dosage form of a drug is traditionally composed of two things: The API, which is

the drug itself; and an excipient, which is the substance of the tablet, or the liquid

the API is suspended in, or other material that is pharmaceutically inert. Drugs are

chosen primarily for their active ingredients.

2.3 NEED FOR THE PROJECT AND ITS IMPORTANCE TO THE COUNTRY AND/REGION

Bulk drugs have become a part of our life for sustaining many of our day-to-day

activities, preventing and controlling diseases. Bulk drugs manufacturing sector in

India is well established and has recorded a steady growth in the overall Indian

industrial scenario. The bulk drugs and allied industries have been amongst the

fastest growing segments of the Indian industry.

The Indian Pharmaceutical Industry today is in the front rank of India’s science-based

industries with wide ranging capabilities in the complex field of drug manufacture


- 17 -

and technology. It is expected to reach a level of Rs 3200 billion by 2012. It ranks

very high in the third world, in terms of technology, quality and range of medicines

manufactured. From simple headache pills to sophisticated antibiotics and complex

cardiac compounds, almost every type of medicine is now made indigenously.

Playing a key role in promoting and sustaining development in the vital field of

medicines, Indian Pharma Industry boasts of quality producers and many units

approved by regulatory authorities in USA and UK. International companies

associated with this sector have stimulated, assisted and spearheaded this dynamic

development in the past years and helped to put India on the pharmaceutical map

of the world.

India's pharmaceutical industry is the third largest in the world in terms of volume.

Its rank is 14th in terms of value. India is also one of the top five active

pharmaceutical ingredients (API) producers (with a share of about 6.5 per cent).

The pharmaceutical industry in India meets around 70% of the country's demand for

bulk drugs, drug intermediates, chemicals, tablets, capsules, orals and injectibles.

.Between September 2008 and September 2009, the total turnover of India's

pharmaceuticals industry was US $21.04 billion. The domestic market was worth US

$12.26 billion. This was reported by the Department of Pharmaceuticals, Ministry of

Chemicals and Fertilizers. As per a report by IMS Health India, the Indian

pharmaceutical market reached US $10.04 billion in size in July 2010. A highly

organized sector, the Indian Pharma Industry is estimated to be worth $4.5 billion,

growing at about 8 to 9 percent annually.

The pharmaceutical industry in Karnataka contributes Rs. 350 crore in revenue to

the State exchequer and provides employment for 12,000 people. Its growth rate is

between 10-12 per cent as against the national pharma growth of 12-14 percent.

Pharma products worth Rs. 2,000 crore are produced annually, which is 10 per cent

of the national production. The exports sales are Rs.850 crore which is 8 per cent of

Indian exports.

International pharma majors have preferred many companies from the State. When

large companies offer their services on contractual basis to global MNCs, they want

to outsource drug production for the domestic market from quality small-medium

manufacturers in State. Here the small-medium units ideally fit into slot as third

party manufacturers and serve as major hubs for pharmaceutical outsourcing. In

fact, two of Indian pharma sectors top five brands, are already outsourced from

Karnataka. The units have been recognized for stringent regulatory enforcement and

known to manufacture quality products.


- 18 -

Hence the proponents have proposed to modify and expand the products in the existing facility of the industry at - M/s. VPL Chemicals Pvt. Ltd., at Plot no: 64, Sompura Industrial Area, Dabaspet, Nelamangala Taluk, Tumkur Road, Bangalore.

2.4 DEMANDS‐SUPPLY GAP Based on their informal survey of the market with their current customers and various traders, they have found that there is a big potential for the range of the products they are planning. These products will be an addition to the current range of their products. 2.5 EXPORT POSSIBILITY

Depending on the international demand of products they shall export the products. 2.6 DOMESTIC/EXPORT MARKETS

Majority of the products will be used for domestic market and some products will

be exported depending on the international market.

2.7 EMPLOYMENT GENERATION (DIRECT AND INDIRECT) DUE TO PROJECT.

M/s. VPL Chemicals Pvt. Ltd., will give direct employment to local people based on qualification and requirement. In addition to direct employment, indirect employment shall generate ancillary business to some extent for the local population.


- 19 -

Chapter-3 PROCESS DESCRIPTION

3.1 TYPE OF PROJECT The proposed project is expansion/modification of the APIs in the existing facility. The total production capacity 31,000 kg/month.

3.2 LOCATION OF THE INDUSTRY M/s VPL Chemicals Pvt. Ltd., is established at plot no 64, Sompura Industrial Area, Dabaspet, Nelamangala Taluk, Tumkur Road, Bangalore. Google Map Showing Project Site is shown in Fig 3.1

Fig 3.1 Google Map Showing Project Site

933 m above MSL; Latitude: 13°13’'29.51"N; Longitude: 77°15'55.85"E

PROJECT SITE


- 20 -

Fig 3.2 Map showing the Project Site Location on District Map of Bangalore

3.3 BASIS OF SELECTING THE SITE

The efficient functioning of any industry mainly depends on the availability of its basic requirements viz. raw materials, fuel, power, water, manpower etc. The industry is established in Sompura Industrial Area, Dabaspet, Bangalore. The choice of the land confers several advantages, which are summarized below.

1. The site is well connected by roadways. 2. Water will be supplied from Bore well. 3. Power will be supplied from BESCOM. 4. No incidence of cyclones, earthquake, floods or landslides in the region.


- 21 -

3.4 SIZE/MAGNITUDE OF OPERATION

The industry “M/s. VPL Chemicals Pvt. Ltd.,” is a small scale industrial unit with a total capital investment of the Expansion project is Eight Lakhs. The total production capacity proposed is 31,000 kg/month.

3.5 PRODUCTS MANUFACTURED

The APIs are proposed to be manufactured/Expanded are given in Table no-3.1

Table 3.1: APIs are proposed to be manufactured

Sl. No.

APIs Existing production capacity(Kg/Month)

Production capacity (kg/month)

1 Fexofenadine HCl 100 4500 ( After Expansion)

2 Ambroxol HCl 500 4500 ( After Expansion)


New Products

4500

4 Fluconazole 4500

5 Febuxostat 1000

6 Pregabalin 3000

7 Dabigetran 3000


9 Terfenadine 3000

3.5.1 Manufacturing Process Description

Manufacturing process Details of each products is given below

1. FEXOFENADINE HCl 1.1 Process Description

Stage I:

Preparation of Methyl-4{4- [4-(hydroxydiphenylmethyl)-l-piperidinyl}-l-

oxobutyl]-α, α-diphenylmethyl benzene acetate.

Methyl-4-(4-chloro-l-oxobutyryl)-α,α-dimethylρhenyl acetate (Ketone) (meta and

para isomers) [Chloro compound]was dissolved in Methyl Iso butyl Ketone followed

by addition of Azacyclanol and water in presence of Sodium bi carbonate and

potassium iodide. Reaction mixture was refluxed. After the reaction was completed,

reaction mixture was cooled to room temperature and aqueous layer was discarded.

Organic layer was filtered and distilled. Add ethyl acetate cool to room Temp. and

filter the material l, i.e., Methyl-4{4- [4-(hydroxydiphenylmethyl)-l-piperidinyl}-l-

oxobutyl]-α, α-diphenylmethyl benzene acetate.


- 22 -

Stage II :

Preparation of Methyl-4{4-r4-(hydroxydiphenylmetyl)-l-piperidinyl}- l-

hydroxybutyll-α,α-dimethyl benzene acetate

The addition of sodium hydroxide in potable water followed by reflux once the

reaction desprotection was completed. The reaction mixture was cooled to room

temperature and slowly cooled cooled to about 0 to 200C followed by addition of

sodium boro hydride. At the same temperature reaction mass stirred for 2 hours.

After the reduction was completed the reaction mass was stirred at room

temperature pH of the reaction mass was adjusted to hydrochloric acid solution. The

crystallized mass was stirred at room temperature. The reaction mixture was

centrifuged and dried.

Stage - III:

Preparation of Methyl-4{4-r4-(hydroxydiphenylmetyl)-l-piperidinyl}- l-

hydroxybutyll-α,α-dimethyl benzene acetate to yield crude isomer of

Fexofenadine base to Fexofinadine Hydrochloride (Pure).

Fexofenadine base thus isolated from the above steps was charged to a mixture of

methanol in methyl iso butyl ketone and treated with IPA HCl to make the pH of the

solution between 3.0 to 4.0 charcolised, filtered and product is isolated after chilling

by centrifuging. The product is dried at 50 - 60C to a constant weight.


- 23 -

1.2 ROUTE OF SYNTHESIS:

Stage-1

MIBK

Sodium bi carbonate

Azocyclonal

Stage-II

Fexofinadine base

OH

O

NO

OH

O

N

O

OH

OH

OH

N

O

OH

OH

O

NO

OH

O

N

O

OH

CH3 CH3

O CH3

Cl

O

NaOH

Sodium boro hydried

Methanol

HCl


- 24 -

IPA HCL

MIBK , Methanol

Stage-3

Fexofinadine baseFexofinaidine HCL

OH

OH

N

O

OH

ClH

OH

OH

N

O

OH

1.3 FLOW CHART

Stage-1

Chloro Compound RO Water

MIBK Sodium Bi Carbonate

Potassium Iodide Ethyl Acetate

Maintenance at 90-95oC

Distillation

Crystallization

Centrifuge and EA washing

Unloading the material (Stage-1)

SS Reactor

SSR-101

1.6 KL

CF-01


- 25 -

Stage-2

Stage-1 Material Caustic Soda Flakes

Methanol Sodium Boro Hydride

Temp. Maintenance 65-68oC

pH Adjustment 6.50 to 6.80

Centrifuge and Methanol Washing

Unloading the material (Crude)

Stage-3

Stage-2 Material Methanol

MIBK

pH Adjustment with IPA HCL

Heating Temp 50oC

Hyflow supercell

Activated Carbon

Filtration

Distillation MIBK

Centrifuge

Unloading the material (Wet cake)

LOD Below 0.5% Drying at 45 to 50oC

Unloading the material (Dry)

SS Reactor

CF-

011

SS Reactor

SSR 108

2.0 KL

SS Leaf

Filter

LF-01

GLR

R-107

1.6 KL

CF-

02

TD-02


- 26 -

1.4 Material balance of Fexofenadine HCl

Stage – I

S. No Name of the Input Quantity

in Kg S. No

Name of the Out put

Quantity in Kg

1 Methyl-2-[4-(4-Chlorobutanoyl)Phenyl]-2-methyl propionate

0.91 1 Stage-I

1.18

2 Azacyclonol 0.77

2 Operation / Evaporation loss

0.2

3 Purified water 2.27 3 Process water 2.6

Sodium bi carbonate 0.39 Ethyl Acetate 0.98

Potassium Iodide 0.01 Residue 0.47

Ethyl Aceetate 1.08

Total 5.43 Total 5.43

Material balance of Fexofenadine HCl

Stage – II


in Kg S. No Name of the Out put

Quantity in Kg

1 Stage-1 1.18

1 Stagae-II 1.09

2 Sodium boro hydride

0.1

2 Operation / Evaporation loss 0.32

3 Purified Water 0.46 3 Process water 1.2

4 NaoH Flakes 0.22 4 Methanol 3.27

5 HCl 0.73 5 Residue 0.44

6 Methanol 3.63


Material balance of Fexofenadine HCl

Stage – II


in Kg S. No Name of the Out put

Quantity in Kg

1 Stage-1 1.18

1 Stagae-II 1.09

2 Sodium boro hydride 0.1



4 NaoH Flakes 0.22 4 Methanol 3.27

5 HCl 0.73 5 Residue 0.44

6 Methanol 3.63



- 27 -

2. AMBROXOL HCl

2.1 Process Description

Stage –I

2-Amino-3,5-Dibromobenzaldehyde (ADBB) is condensed with trans-4-

Aminocyclohexanol in methanol gives Schiff base material is reduction with sodium

borohydride in methanol gives Ambroxol base in good yield.

Stage – II Ambroxol base is converted into corresponding hydrochloride in acetone by using

HCl followed by filtration gives Ambroxol Hydrochloride


. HCL

Ambroxol base

C13

H18

Br2 N

2O : 378.10

Br

Br

NH2

NH

OHNH2

OH

Br

Br

NH2

O +

Ambroxol base

C13

H18

Br2 N

2O : 378.10

Methanol

Sodium Boro Hydried

Trans 4-Amino cyclohexonol

C6H13NO : 115.18

Stage-I

Stage-II

Br

Br

NH2

NH

OH

Br

Br

NH2

NH

OH

Acetone

HCl

Ambroxol HCl

C14

H18

Br2 N

2OCl : 414.6

2-Amino-3,5-di bromo benzaldehyde

C7H

5Br

2NO : 278.929

AMBROXOL HCL ROS


- 28 -

2.3 FLOW CHART

Stage-1

Trans 4-Amino Cyclohexanol Purified Water

2-Amio-3,5- dibromo benzaldehyde

Organic layer

Methanol Sodium Boro Hydride

Centrifuge and Methanol Washing

Unloading the material (Crude)

SS Reactor

SSR-101

1.6 KL

SS Reactor

CF-

01


- 29 -

Stage-2

Stage-1 Material

Acetone

pH Adjustment with HCL

Heating Temp 50oC

Hyflow supercell

Activated Carbon

Filtration

Distillation Acetone

Centrifuge




SS Reactor

SSR 108

2.0 KL

CF-

02

TD-02

SS Leaf

Filter

LF-01

GLR

R-107

1.6 KL


- 30 -

2.4 Material balance of Ambroxol HCl

Stage – I

S.

No Name of the Input

Quantity

in Kg

S.

No Name of the Out

put

Quantity

in Kg

1 2-amino-3,5-

dibromobenzohydrazide

0.72 1 Stage-1 0.85

2 Trans 4-amino cyclohexnol 0.3 2 Operation /

Evaporation loss 0.19

3 Sodium Boro Hydried 0.1 3 Process water 2.72

4 Methanol 4.08 Methanol 3.67

5 Purified water 2.55 Residue 0.32


Material balance of Ambroxol HCl

Stage – II

S.


Quantity

in Kg

S.

No Name of the Out

put

Quantity in

Kg

1 Stage-1 0.85 1 Ambroxol Hcl 1

2 Acetone 6.00 2 Operation /

Evaporation loss

0.2

3 Hcl 0.18 3 Acetone 5.52

4 Activated Carbon 0.02 4 Process water 0

5 Hyflow 0.01 5 Resdiue 0.34


http://www.chemicalbook.com/ProductChemicalPropertiesCB41009990_EN.htm

http://www.chemicalbook.com/ProductChemicalPropertiesCB41009990_EN.htm


- 31 -

3. Amlodipine Besylate 3.1 PROCESS DESCRIPTION

Stage-1 Mono methylamine is charged into the reactor and Phathoyl Amlodipine is charged

under stirring at 25 - 30C. The reaction mass is maintained for about 16 hours between 25 and 30°C and Centrifuged. Wet cake is washed with DM water and dried and taken for next stage of processing. Stage-II To Stage-1 material, Benzene Sulphonic acid is added slowly and the mass is maintained for about 3 hours, centrifuged and washed with DM water. The wet material is charged into SS tray drier. The Material is air dried for 1 hour and then

at 60C to 65C with steam. Drying is continued till water content is less than 0.5% w/w. Dried material is unloaded and taken for next stage of purification. Stage III (Purification) The stage II material is taken in a reactor and treated with methanol and charcoal and filtered. The filtrate is distilled to remove methanol and the residue cooled. Ethyl acetate is added to the residue and centrifuged, the mother liquor is collected to recover the ethyl acetate and the wet material is dried. 3.2 ROUTE OF SYNTHESIS

Cl

N+

O

CH3

O

CH3

H

O N

O

O

O CH3

O

Stage-1

CH3 NH2

Phthloyl Amlodipine

M.F :C28H27ClN2O7

M.W :538.98

Mono Methyl Amine

+

Cl

N+

O

CH3

O

CH3

H

O

O CH3

O

NH2

Amlodipine base


- 32 -

Cl

N+

O

CH3

O

CH3

H

O

O CH3

O

NH2

+ S

O

O

OH

Cl

N+

O

CH3

O

CH3

H

O

O CH3

O

NH2

S

O

O

OH

Amlodipine besylate

Stage-2

Cl

N+

O

CH3

O

CH3

H

O

O CH3

O

NH2

+ S

O

O

OH

Cl

N+

O

CH3

O

CH3

H

O

O CH3

O

NH2

S

O

O

OH

Amlodipine besylate

Stage-2


- 33 -

3.3 FLOW CHART

Stage-I

MMA

Phthaloyl Amlodipine

Water

To next step

Stage-II

Dried Stage II

SSR

Reactor

Centrifuge ML’s to ETP

Wet material

Drier

Drying

Stage-1

Water

Reactor Stage-I

material

Water + Benzene

Sulphonic acid

Water

Dryer

CF ML’s to ETP


- 34 -

Stage-III

Stage-II

Ethyl Acetate

Collect the spent Ethyl Acetate

Wet material

SSR

Reactor

Sparkler

Filter

GLR

Reactor

Drier

Charcoal Methanol

Distill Methanol

Ethyl Acetate

Cool to 0-5°C

Amlodipine Besylate

Miller

Sifter

Blender

CF


- 35 -

3. AMLODIPINE BESYLATE Material balance of Amlodipine besylate

Stage – I

S.

No

Name of the

Input

Quantity in

Kg

S.

No

Name of the Out

put

Quantity in

Kg

1 Mono methylamine 2.62 1 Amlodipine base 0.81

2 Phathoyl

Amlodipine

1.07 2 Operation /

Evaporation loss

0.08



Material balance of Amlodipine besylate

Stage – II

S.

No

Name of the

Input

Quantity

in Kg

S.

No

Name of the Out

put

Quantity in

Kg

1 Amlodipine base 0.81 1 Amlodipine besilate

Crude 1.16

2 Benzene sulphonic

acid 0.43 2 Operation /




Material balance of Amlodipine besylate

Stage – III

S.

No

Name of the

Input

Quantity

in Kg

S.

No

Name of the Out

put

Quantity in

Kg

1 Amlodipine

besilate

1.16 1 Amlodipine besilate

pure

1

2 Methanol 5.81 2 Methanol 5.75

3 Ethyl acetate 5.81 3 Ethyl acetate 5.79

4 Activated charcoal 0.02 4 Operation /

Evaporation loss

0.06

5 Hyflow 0.02 5 Residue 0.22



- 36 -

4. Fluconazole

4.1 Brief Manufacturing Process Stage-1 To di-floro aceto phenone material, 1,2,4 trizole, Toluene and TMSI is added slowly and the mass is maintained for about 4 hours, Adjust pH with KOH flakes and kept under maintenance at 65-68oC,Cool to 5oC and centrifuge, washed with Toluene. The wet material is charged in to SS tray drier. The Material is air dried for 1 hour

and then at 45C to 50C with steam. Drying is continued till LOD content is less than 0.5% w/w. Dried material is unloaded and taken for next stage of purification. Stage 2 The stage I material is taken in a reactor and treated with MDC, Citric acid adjust the pH 3.5 with HCL and charcoal and filtered. The filtrate is distilled to remove MDC and the mother liquor is collected to recover the MDC and the wet material is dried.

4.2 ROUTE OF SYNTHESIS

Stage-I&II

O

N

N

NF

F

NH

N

N

OH

N

N

NF

F

N

N

N

+

2,4-Difluoro-1-(1H-1,2,4 Trizoyl) Aceto phenone

C10H7F2N3O 223.18

1,2,4 Trizole

C3H9IOS 69.06

TMSI

FLUCONAZOLE


- 37 -

4.3 FLOW CHART

Stage-1

Difloro Aceto phenone RO Water

TMSI Potassium Hydroxide

1,2,4 Triazole Toluene

Maintenance at 65-68oC

Distillation

Crystallization

Centrifuge and Toluene washing

Unloading the material

SS Reactor

CF-01


- 38 -

Stage-II

Stage-1 Material Citric acid

MDC

pH Adjustment with HCL(CP Grade)

Heating Temp 60oC

Hyflow supercell

Activated Carbon

Filtration

Distillation MDC

Centrifuge




SS Reactor

CF

TD

SS Leaf

Filter

GLR


- 39 -

Material balance of Fluconazole

Stage – I

S.

No

Name of the

Input

Quantity

in Kg S. No

Name of the Out

put

Quantity

in Kg

1 1,2,4 Triazole 0.52 1 Fluconazole(Crude) 1.16

2 Potassium

Hydroxide 0.75 2 Toluene 0.34

3 Tri methyl

sulfoxonium Iodide 0.52 3 Process water 3.48

4 Di floro acetone

phenone 1.16 4

Operation /


5 Toluene 0.39 5 Residue 1.19

6 Purified Water 2.9 6 0


Material balance of Fluconazole

Stage – II

S.

No

Name of the

Input

Quantity

in Kg S. No

Name of the Out

put

Quantity

in Kg

1 Fluconazole(Crude) 1.16 1 Fluconazole(Pure) 1.00

2 CP HCL 0.83 2 MDC 1.40

3 MDC 1.56 3 Process water 0.90

4 Citric acid 0.03 4 Operation /


5 Carbon 0.06 5 Residue 0.30

6 Hyflow 0.02



- 40 -

5. Febuxostat

5.1 Process Description: Stage-I: Ethyl-2-(3-cyano-4-isobutoxyphenyl)-4-methyl-5-thiazolecarboxylate (NV07-3) is

hydrolyzed with sodium hydroxide solution in isopropyl alcohol to furnish the

product. The pH is adjusted with hydrochloric acid and solid is separated by

filtration as Febuxostat crude.

Stage-II Febuxostat (crude) is dissolved in acetone and charcolised. After filtration,

acetone is distilled out and solid is filtered to give Febuxostat.

5.2 Route of Synthesis:

Ethyl-2-(3-Cyano-4-isobutoxyphenyl)-4- IPA, NaOH, HCl Febuxostat Crude methyl-5-thiazolecarboxylate M.Wt.=344.428 Stage II – Purification of Febuxostat

H 3C H O

H 3C

H O S O Acetone S

H 3C O O

N

H 3C O

C H 3

C H 3 N

N Febuxostat Crude N Febuxostat

M.Wt=316.37


- 41 -

5.3 Process Flow chart:

STAGE –1:

NV07-3 Purified Water

Sodium hydroxide Hydrochloric acid

Isopropyl alcohol

Maintenance Temp.

Distillation

Crystallization

Centrifuge and EA washing


Purification:

Stage-I Crude Acetone

Temp. Maintenance

Centrifuge and Acetone Washing

Unloading the material (Pure)

SS Reactor

1.6 KL

CF

SS Reactor

103

CF


- 42 -

5.4 MATERIAL BALANCE

Material balance of FEBUXOSTAT

Stage – I

S. No

Name of the Input Quantity

in Kg

S. No

Name of the Out put

Quantity in Kg

1

Ethyl-2-(3-cyano-4-isobutoxyphenyl)-4- methyl-5-thiazolecarboxylate 1.528

1 Stage-1 1.299

2 Sodium hydroxide 0.231


3 Con. Hydrochloric acid 0.624

3 Process water 34.864

4 Isopropyl alcohol 6.005

Isopropyl alcohol 5.705

5 Water 34.009

Residue 0.289


Material balance of FEBUXOSTAT

Stage – II

S. No


in Kg S.

No Name of the

Out put Quantity

in Kg

1

Febuxostat crude 1.299

1 FEBUXOSTAT 1

2

Acetone 13.338


3

Activated carbon 0.065

3 Acetone

12.671

4

Celite 0.057

4 Spent Carbon

0.187

5

5 Residue (Org. + Carbon) 0.367



- 43 -

6. Pregabalin

6.1 PROCESS DESCRIPTION Stage-I (+)-3-(Carbamoy methyl)-5-methyl hexanoic acid (Di Acid) react with R(+) Phenyl Ethyl amine in the presence of Chloroform to get the product R-(-)-3-(Carbamoylmethyl)-5-methylhexanoic acid Stage-II R-(-)-3-(Carbamoylmethyl)-5-methylhexanoic acid react with Bromine in the presence of alkaline condition by using sodium hydroxide in the presence of chloroform and purified water to get pregabalin technical Stage-III The product of Pregabalin, the technical grade, dissolved with Iso propyl alcohol at temperature 80-85oC and filtered the reaction mass. Then cool to 0-5oC then filter in Centrifuge to get Pregabalin pharma


Stage-I

NH2

OCH3

CH3

OH O

CH3 NH2

R-(+)-1-Phenyl ethyl amine salt ofR-(-)-3-(Carbamoylmethyl)-5-methylhexanoic acid

NH2

OCH3

CH3

OH O

HCl

NaOH

Stage-II

NH2

OCH3

CH3

OH O

CH3

CH3

OH O

NH2

NaoCl

(

R-(-)-3-(Carbamoylmethyl)-5-methylhexanoic acid S-(+)-3- Amino methyl)-5-methyl hexanoic acid (Tech) C9H17NO3 : 187.24 C8H17NO2 : 159.226


- 44 -

Stage-III

CH3

CH3

OH O

NH2

CH3

CH3

OH O

NH2

IPA

Water

6.3 FLOW CHART

Stage-I

CMH Acid

Chloroform Sodium Hydroxide

R(+) Phenyl ethyl hexanoic acid

HCL

Maintenance at 35oC

Crystallization

Cf. and Chloroform washing

Unloading the material

SS Reactor

4.0 KL

CF-01


- 45 -

Stage-II

Stage-2 Material NaOH Flakes

Bromine DM water


Cool to 10oC

Centrifuge and DM Washing

Unloading the material (Technical)

SS Reactor

2.0 KL

CF-

01


- 46 -

Stage-III

Stage-III Material

Iso Propyl alcohol

Heating to temp 50oC

Cool to 0oC to 5oC

Hyflow supercell

Activated Carbon

Filtration

Distillation IPA

Centrifuge




SS Reactor

2.0 KL

CF-

02

TD-02

SS Leaf

Filter

LF-01

GLR

2.0 KL


- 47 -

Material balance of Pregabalin

Stage – I

S.


Quantity

in Kg

S.

No

Name of the Out

put

Quantity

in Kg

1

(±)-3-

(Carbamoylmethyl)-5-

methylhexanoic acid

(CMH Acid)

3.64 1 Stage-I 1.42

2 R(+) Phenyl Ethyl

amine 1.86 2

(±)-3-

(Carbamoylmethyl)-

5-methylhexanoic

acid (CMH Acid)

2.22

3 Chloroform 43.69 3 R(+) Phenyl Ethyl

amine 1.79

4 Methanol 0.72 4 Chloroform 42.44

5 NaOH 0.27 5 Operation /


6 HCL 0.97 6 Process water 1.14

7 Purified Water 0.27 7 Residue 2.27 Total 51.42 Total 51.42


Stage – II

S.

No


in Kg

S.

No

Name of the

Out put Quantity

in Kg

1

R-(-)-3-

(Carbamoylmethyl)-5-

methylhexanoic acid

1.68

1 Pregabalin

(Crude) 1.18

2 NaoH flakes 1.1 2 Process Water 7.25

3 Bromine

1.3

3 Operation /


4 Purified water 4.3 4 Residue 0.46

5 HCl 2.36 5 0



Stage – III

S.


Quantity

in Kg

S.

No

Name of the

Out put

Quantity

in Kg

1 Pregabalin (Crude) 1.18 1 Pregabalin (Pure) 1

2 Iso propyl Alcohol 4.71 2 Iso propyl Alcohol 4.5

3 Purified Water 4.71 3 Water 4.57

4 Hyflow 0.06 4 Operation /


5 Organic Residue 0.5



- 48 -

7. Dabigetran

7.1 Process Description:

Stage-I:

The propanoic acid methyl ester derivate of formulae-I is dissolved in IPA and acetic

acid, hydrogenated with damp Pd/C at RT at 2 bar hydrogen pressure. After

completion of the reaction the catalyst is filtered off and dissolved in IPA was added

to filtrate. To get formulae-II precipitated out which was filtered off and dried.

Stage-II:

The Tosylate salt obtained in the stage I was dissolved in acetone and the mixture

is combined with hexyl chloroformate in presence of potassium hydroxide at

temperature 15oC. After completion of the reaction the precipitated product is

filtered off and washed with acetone mixture. The resulting crude is crystallized

with water. Schematic diagram of Dabigatran is shown below and material balance

for Dabigatran is presented below

7.2 Route of synthesis: Stage-I CH CH

3

N3 N O

O

N NH

CO2

O N NH O H2,Pd,C,IPA,ACOH

N HN

NH

O N NH

O N 2

PTSA,

O N

M. Wt 44.01

O N

M. Wt: 499.56

M. Wt: 541.56

[ I ] [ II ]

Stage-II

CH3 Acetone/ CH

3 O O

C6 H13

N NH

KOH N KCl

O HN

Mol. Wt.: 56.11 O N M. Wt: 36.46

O N NH2 Hexa chloro formate O N

N HN NH

N 2

H2O

O N M.Wt.164.63 O N

M. Wt: 499.56 Dabigetran (Pharma) Mol. Wt.: 18.02

[ II ]

M. Wt: 627.73


- 49 -

7.3 Process Flow chart:

STAGE –1:

Propionic acid ethyl ester (KSM) Purified Water

Acetic acid IPA

P-toulene sulphonic acid

Maintenance Temp.

Distillation

Crystallization

Centrifuge


Purification:

Stage-I Crude

Potassium hydroxide Acetone

Hexa chlorofomate

Temp. Maintenance

Centrifuge and Acetone Washing

Unloading the material (Pure)

SS Reactor

1.6 KL

CF

SS Reactor

103

CF


- 50 -

9.4 MATERIAL BALANCE

Material balance of Dabigetran

Stage – I

S. No

Name of the Input Quantity in Kg

Output

Quantity in Kg

Remarks

1 3-[(1-Methyl-2-{[4-(5-oxo-4,5-dihydro- [1,2,4]oxadiazol-3-yl)-phenylamino]-methyl)-1H benzoimidazole-5- carbonyl)-pyridin-2-yl- amino]-propionic acid ethyl ester

0.0485 Stage-1 product

0.0423 To stage-2

2 P-toluene sulphonic acid

0.0125 Carbon dioxide

0.0037 let out in atmosphere safely

3 Acetic acid 0.01 Solvents

4 IPA 1.25 IPA 0.7121

IPA recovered 1.225 Recovered & Reused

IPA loss 0.0063 Fugitive loss

IPA residue 0.0188 Solvent in residue

3-[(1-Methyl-2-{[4-(5-oxo- 4,5-dihydro- [1,2,4]oxadiazol-3-yl)- phenylamino]-methyl)-1H benzoimidazole-5- carbonyl)-pyridin-2-yl- amino]-propionic acid ethyl ester

0.0024 Organic residue



Acetic acid 0.01 Organic residue

Total Input 1.321 Total out put 1.321


- 51 -

Material balance of Dabigetran

Stage – II

S. No

Name of the Input

Quantity in Kg

Output

Quantity in Kg

Remarks

1 Stage I Product 0.0423 Dabigetran 0.05 Final Product

2 Hexa chlorofomate 0.014 Potassium chloride

0.0063 To Wastewater

3 Acetone 0.6 Water formed in reaction


4 Potassium Hydroxide

0.0048 Acetone recovered

0.5748 Recovered & Reused

5 Hydrochloric acid 0.00019 Acetone loss 0.0036 Fugitive loss

6 Water 0.5 Acetone to Wastewater


Acetone residue

0.0168 Solvent in residue

Organics

Stage I Product


Hexa chlorofomate


Water 0.5001 To Waste water

Total Input 1.1612 Total out put 1.1612

8. Verapamil HCl 8.1 PROCESS DESCRIPTION Stage 1: 2-(3,4-dimethoxyphenyl)-3-methylbutanenitrile is condensed with N-(3-chloropropyl)-N-[2-(3,4-dimethoxyphenyl) ethyl]-N-methylamine in presence of sodamide, nitrogen and toluene. Methanol is added to neutralize sodamide and later on with water. The solvent is separated and used directly for next step. Stage 2 Verapamil base in toluene is treated with activated carbon, filtered and the filtrate is treated with HCl to give a precipitate of verapamil HCl, which is filtered, washed with toluene.


- 52 -


Scheme:

Stage-I

Stage-II

HCl


- 53 -

Filtrate

Centrifuge

Verapamil HCl

8.3 FLOW CHART

Stage-I

2-(3,4-dimethoxyphenyl)-3-

methylbutanenitrile Sodamide, N2

N-(3-chloropropyl)-N-[2- Reactor

(3,4-dimethoxyphenyl)

ethyl]-N-methylamine Toluene

Methanol, water

Organic layer

Filter

Filtrate

Next step

Material Balance

Stage-II

Verapamil base in toluene

Activated carbon Reactor

Filter

HCl

Wash with toluene


- 54 -

Material balance of Verapamil HCl

Stage – I

S.


Quantity

in Kg

S.

No Name of the Out put

Quantity

in Kg

1

2-(3,4-

dimethoxyphenyl)-3-

methylbutanenitrile

1.08 1 Verapamil base 1.32

2

N-(3-chloropropyl)-N-

[2-(3,4-dimethoxy

phenyl) ethyl]-N-

methylamine

0.75 2 Toluene 6.94

3 Sodamide 0.16 3 Operation / Evaporation

loss 1.98

4 Toluene 7.21 4 Process water 4.07

5 Methanol 2.68 5 Process Residue 1.07 6 Purified Water 3.5 0


Material balance of Verapamil HCl

Stage – II

S.


Quantity

in Kg

S.

No Name of the Out put

Quantity

in Kg

1 Verapamil base 1.32 1 Verapamil HCl 1.00

2 Toluene 5.62 2 Toluene 5.58

3 HCl 0.61 3 Operation / Evaporation

loss 0.06

4 Activated carbon 0.01 4 Process water 0.74

5 Hyflow 0.02 5 Residue 0.20


9. Terfenadine

9.1 Process Description

Stage – I

1-(4-tert-butyl phenyl)-4-chloro-1-butanone was dissolved in Methyl Iso butyl Ketone

followed by addition of Azacyclonol and water in presence of Sodium bi carbonate

and potassium iodide. Reaction mixture was refluxed for about 36 hours. After the

reaction was completed, reaction mixture was cooled to 80oC charging by purified

water. The reaction mixture was stirred at same temp. for 30 min, there after

allowed the mass to settle and separate aqueous layer. Organic layer was distilled

under reduced pressure and degassed for 2 hours to get the oily mass. Known volume

of water and Ethyl acetate was added to the reaction mixture at the same

temperature and stirred for 2 hours at 5oC, the product was filtered and washed


- 55 -

with Ethyl acetate, i.e., 1-(4-tert-butylphenyl)-4-{4-

[hydroxyl(diphenyl)methyl]piperidin-1-yl}butan-1-one

Stage – II

Stage-I 1-(4-tert-butylphenyl)-4-{4-[hydroxyl(diphenyl)methyl]piperidin-1-yl}butan-

1-one was added to a mixture of methanol. The reaction mixture was cooled to 10°C

and a solution of sodium boro hydride was added. The reaction mixture was stirred

at room temperature for 4 hours and monitored by TLC. After the reduction was

completed the solution was heated to 60°C and the pH was adjusted to neutral by

adding with dilute hydrochloric acid The reaction mixture was again heated to reflux

for about 2 hour and cooled to 5° C, the product was filtered and washed with water

and methanol. The material was dried. i.e., Terfenadine.


TERFENADINE ROUTE OF SYNTHESIS Stage-1

CH3CH3

Cl

O

CH3

NH

OH

OH

O

N+

1-(4-tert-butyl phenyl)-4-chloro-1-butanone

M.F C14

H19

CLO2

M.Wt. 238.75

1-(4-tert-butylphenyl)-4-{4-[hydeoxy(diphenyl)methyl]piperidin-1-yl}butan-1-one

M.F: C32

H39

NO2 :M.Wt. 469.658

Azocyclonol

M.F. C18H21NO, M.Wt : 267.365

MIBK,NaHCO3

KI

Stage-2

1-[4-(1,1-Dimethylethyl)phenyl]-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]buta

n-1-ol.

M.F. C32

H41

NO2 : M.Wt 471.7

OH

O

N

OH

OH

N

SBH

Methanol

1-(4-tert-butylphenyl]-4-[4-(hydroxy(diphenyl)methyl]piperidin-1-yl]butan-1-ol.

M.F. C32

H39

NO2 : M.Wt 469.658


- 56 -

9.3 FLOW CHART

STAGE –1:

TR Chloro Compound Purified Water MIBK Sodium Bi Carbonate Potassium Iodide Ethyl Acetate Maintenance Temp. Distillation Crystallization Centrifuge and EA washing Unloading the material (Stage-1)

SS Reactor

1.6 KL

CF


- 57 -

Stage-2

Stage-1 Material Sodium Boro Hydried Methanol


pH Adjustment 6.50 to 6.80 Centrifuge and Methanol Washing Unloading the material (Crude)

Purification:

Stage-II Crude Methanol


Cool to 5oC Centrifuge and Methanol Washing Unloading the material (Pure)

SS Reactor

103

CF

SS Reactor

103

CF


- 58 -

Material balance of Terfenadine

Stage – I

S. No Name of the

Input

Quantity

in Kg

S.

No

Name of the

Out put

Quantity in

Kg

1 1-(4-tert-

butylphenyl)-4-

chloro-1-butanone 0.91

1

Stage-I 1.18

2

Azacyclonol 0.77 2

Operation /

Evaporation

loss

0.2

3 Purified water 2.27 3 Process water 2.6 4 Sodium bi

carbonate 0.39 Ethyl Aceate

0.98

5 Potassium Iodide 0.01 Residue 0.47 6 Ethyl Aceetate 1.08


Material balance of Terfenadine

Stage – II

S. No Name of the

Input

Quantity

in Kg

S.

No

Name of the

Out put

Quantity in

Kg

1 Stage-1 1.18 1 Stagae-II 1 2 Sodium boro

hydride 0.1 2 Operation /

Evaporation

loss 0.45 3 HCl 0.46 3 Methanol 4.26 4 Methanol 4.49 4 Residue 0.52



- 59 -

3.6 RAW MATERIALS The raw materials required for the manufacture of APIs are appended in the table 3.2 below. Raw materials as listed will be procured as per the production requirement.

Table -3.2 Raw Materials Requirement for manufacture of API Sl. No.

Product Raw materials Quantity required Solvents required after

recycling kg/annum

kg/batch kg/month kg/annum

1 Fexofenadine HCL

Methyl (Stage1) 273 4095 49140 -

Azacylonol 231 3465 41580 -

Potassium iodide

3 45 540 -

Sodium bi carbonate

117 1755 21060 -

Sodium Boro hydride

30 450 5400 -

Sodium hydroxide flakes

66 990 11880 -

HCL 300 3285 39420 -

methyl iso butyl ketone

1092 16380 196560 -

Hyflow 3 45 540 -

Activated Carbon

3 45 540 -

Purified water(stage 1)

681 10215 122580 -

Stage 2 138 2070 24840 -

Methanol(stage 2)

1089 16335 196020 19440

Stage 3 165 2475 29700 2700

Ethyl acetate 324 4860 58320 5400

Iso propyl alcohol

165 2475 29700 2700

2 Ambroxol HCL

2-amino-3,5-Dibromo Benzaldehyde

216 3240 38880 -

Trans 4-aminocyclohexnol

90 1350 16200 -

Sodium Borohydride

30 450 5400 -

Activated carbon

6 90 1080 -

Hy flow 3 45 540 -

HCL 54 810 9720 -

Purified water 765 11475 137700 -

Acetone 1800 27000 324000 25920


- 60 -

Methanol (Stage I)

1224 18360 220320 22140

3 Amlodipine besylate

Monomethylamine

786 11790 141480 -

Phathoylamlodipine

321 4815 57780 -

Benzene sulphonic acid

129 1935 23220 -

Activated charcoal

6 90 1080 -

Hy flow supercell

6 90 1080 -

Purified water (stage 1)

621 9315 111780 -

Stage 2 735 11025 132300 -

Methanol 1743 26145 313740 3240

Ethyl acetate 1743 26145 313740 1080

4 fluconazole Di-floro-tetra-aceto-phenone

348 5220 62640

Trimethyl solfoxonium iodide

156 2340 28080

1,2,4 triazole 156 2340 28080

Potassium hydroxide

225 3375 40500

HCL 249 3735 44820

Hyflow supercell

6 90 1080

Citric acid 9 135 1620


Toulene 117 1755 21060 2700

5 Febuxostat Ethyl-2-(3-cyano-4-isobutoxyphenyl)-4-methyl-5-thiazolecarboxylate

153 1530 18360

Febuxostat crude

130 1300 15600

NAOH 23 230 2760

HCL 62 620 7440

Acetone 1333.8 13338 160056 8004

Isopropyl alcohol

600 6000 72000 3540

Activated carbon

6 60 720

Celite 6 60 720


- 61 -

Water 3401 34010 408120

6 Pregabalin R-(-)-3- carbamoymethyl hexanoic acid

504 5040 60480

Hydrochloric acid

708 7080 84960

Sodium Hydroxide

330 3300 39600


Isopropyl alcohol

1413 14130 169560 7560

7 Dabigetran 3-[(1-Methyl-2-

{[4-(5-oxo-4,5-

dihydro-

[1,2,4]oxadiazol

-3-yl)-

phenylamino]-

methyl)-1H

benzoimidazole-

5- carbonyl)-

pyridin-2-yl-

amino]-

propionic acid

ethyl ester

15 150 1800


4 40 480

Acetic acid 3 30 360

IPA 375 3750 45000

Hexa

chlorofomate

4 40 480

Acetone 180 1800 21600

Potassium

Hydroxide

2 20 240

Hydrochloric

acid

0.1 10 120

Water 150 1500 18000

8 Verapamil HCL

2-(3,4- Dimethoxyphenyl)-3-methylbutanenitrile

324 3240 38880

N-(3-choloropropyl)-N-[2-(3,4-dimethoxyphenyl)ethyl]-N-methylamine

225 2250 27000

Sodamide 48 480 5760


- 62 -

HCL 183 1830 21960

Activated carbon

3 30 360

Hyflow supercell

6 60 720

Toluene (stage 1 )

2163 21630 259560 9740

Stage 2 1686 16860 202320 1440

RO water 1050 10500 126000

Methanol 804 8040 96480

9 Terfenadine 1-(4-tert-butyl phenyl)-4-chloro-1-butanone

273 2730 32760

Azacyclanol 231 2310 27720

Potassium Iodide

3 30 360

Sodium bi carbonate

117 1170 14040

Sodium boro hydride

30 300 3600

HCL 138 1380 16560


Methanol 1347 13470 161640 3600

Ethyl Acetate 324 3240 38880 8280

3.6.1 STORAGE FACILITY FOR RAW MATERIALS AND PRODUCTS Adequate storage facilities are provided for the raw materials, products etc. the

details of Storage Facilities is given in Table-3.3

Table 3.3:- Details of Storage Facilities

Sl. No. Storage Facility for Facility

1 Raw Materials Warehouse 2 Products Bonded finished goods store

3 Industrial Effluent Effluent treatment Plant with Multiple Effective Evaporator (MEE) followed by RO filtration with adequate storage tanks

4 Hazardous Waste In organic Process residue and organic waste from process is collected in HDPE Bags and sent to PCB authorized Processers for land filling Spent carbon is collected in HDPE Bags and sent to PCB authorized Processers for land filling Used Containers after detoxification will be sold to authorized agents.


- 63 -

3.6.2 MACHINERY & EQUIPMENT DETAILS The detailed list of machinery & equipments in the industry are appended in the tables 3.4 below

Location: Pharma Block

Table 3.4 List of Major Production Equipment

Location: Intermediate Block

Location: Pilot Block

Sl. No.

Name of the Equipment

Identification Number

MOC Capacity

1. Glass Lined Reactor R-107 GLR 1.6 KL 2. SS Reactor R-106 SS 316 2.0 KL

3. Leaf Filters LF-01 SS 316 100 L 4. Nutsche Filter NF-02 SS 316 500 L 5. Centrifuge CF-02 SS 316 36”

6. Tray Dryer TD-02 SS 316 48 Trays

7. Multi Mill MM-01 SS 316 100 Kg / Hr 8. Double Cone Blender B-01 SS 316 500 L

9. Sifter SF-01 SS 316 30”

10 Pulveriser PUL-01 SS 316 50 Kg / Hr

Sl. No.



MOC Capacity

1. Glass Lined Reactor R-104 GLR 3.0 KL 2. Glass Lined Reactor R-102 GLR 1.6 KL

3. Glass Lined Reactor R-109 GLR 3.0 KL

4. SS Reactor R-105 SS 316 3.0 KL

5. SS Reactor R-103 SS 316 2.0 KL 6. SS Reactor R-101 SS 316 1.6 KL 7. SS Reactor R-108 SS 316 2.0 KL

8. SS Receivers REC-01 SS 316 500 L

9. SS Receivers REC-02 SS 316 500 L 10. SS Receivers REC-03 SS 316 500 L

11. SS Addition Tanks AT-01 SS 316 500 L

12. SS Addition Tanks AT-02 SS 316 500 L 13. SS Addition Tanks AT-03 SS 316 500 L

14. FRP Addition Tanks AT-04 FRP 500 L

15. Leaf Filter LF-101 SS 316 100 L

16. Nutsche Filter NF-101 SS 316 500 L

17. Centrifuge CF-101 SS 316 48”

18. Tray Dryer TD-101 SS 316 48 Trays

Sl. No.



MOC Capacity

1. All Glass Assembly PB-01 Borosil 25L




- 64 -

Table-3.4a. List of Major Utilities

S.No Name of the equipment Capacity Qty (Nos)

1 Brine Chiller (-20 Deg C) 20TR 1

2 Boiler 2 Tons/hr 1

3 Cooling tower 80TR 1

4 Cooling tower 200TR 1

5 RO plant 3KL/hr 1

6 High Vacuum pump (oil ring type) 2TR 1

7 High Vacuum Pump (Jet type) 40TR 2

8 Solvent storage tanks 15KL 2

9 Air Compressor (110ltrs) 100Psi 1

10 DG set 250KVA 1

11 Acid storage (HCl) tank (PP/FRP) 10KL 1

12 Scrubber 2000CFM 1

13 Multiple Effect Evaporator 600ltr/hr 1

Table- 3.4b List of major laboratory Equipments


Sl. No.

Name of the Equipment Identification Number

Make & Model

1. Analytical Balance VPL/QC/AB 001 Contech, CA – 214

2. Analytical Semi MircoBalance

VPL/QC/AB 002 Radwag, Model No. AS 60/220.R2

3. KF Titrator VPL/QC/KF 001 Galaxy Scientific Equipments

4. KF Titrator VPL/QC/KF 002 Polmon Instruments MI 453

5. Melting Point Apparatus VPL/QC/MP 001 DBK Instruments 6. TLC View Chamber VPL/QC/TV 001 Galaxy Scientific Equipments

7. Hot Air Oven VPL/QC/OV 001 Galaxy Scientific Equipments 8. Vacuum Oven VPL/QC/VO 001 Multispan UTC 113P 9. Muffle Furnace VPL/QC/MF 001 Bio – Technics India, 774

10. pH Meter VPL/QC/PH 001 Henna : HI 2215 11. pH Meter VPL/QC/PH 002 Galaxy Scientific Equipments SV4

12. HPLC VPL/QC/LC 001 Shimadzu, LC-2010

13. HPLC VPL/QC/LC 002 Waters, Alliance. 2695

14. Gas Chromatography VPL/QC/GC 001 Shimadzu, GC-2014, C11484506286 with Head space Tekmar

15. Ultrasonic Sonic cleaner VPL/QC/SC 001 Ultrasonic Sonic

16. UV-spectrophotometer VPL/QC/UV 001 Shnmadzu : UV 1601

17. Stability Chambers VPL/QC/STB 001 ADITI Associate

18. Stability Chambers VPL/QC/STB 002 MAK Pharma

19. Stability Chambers VPL/QC/STB 003 MAK Pharma

20. Potentiometer VPL/QC/AT 001 Spectra Lab Model No. AT38-C


- 65 -

3.7 RESOURCE OPTIMIZATION/RECYCLING AND RE-USE ENVISAGED IN THE PROJECT

3.7.1 Solvent Recovery & Re-Use

Various solvents are proposed to be used during the manufacturing process. The

solvents proposed to be recovered and recycled during the process of recovering the

solvent of such product are detailed in table 3.5 below.

Table 3.5 Solvent Recovery

Sl.No

Product Raw materials Quantity (kg/annum)

Recovered and recycled

Lost

1 Fexofenadine HCL Stage 1



Stage 3 Iso propyl alcohol 27000 2700

Methanol 27000 2700

Methyl iso butyl ketone

186840 9720

2 Ambroxol HCL Stage 1

Methanol 198180 22140

Stage 2 Acetone 298080 25920

3 Amlodipine besylate Stage 3

Methanol 310500 3240


4 fluconazole Toluene 18360 2700

5 Febuxostat Iso propyl alcohol 68460 3600

Acetone 152052 8004

6 Pregabalin Stage 3

Iso propyl alcohol 162000 7560

7 Dabigetran Iso propyl alcohol 44100 227

Acetone 6897.6 432

8 Verapamil HCL Stage 1

Toluene 249840 9720

Stage 2 Toluene 200880 1800

9 Terfenadine Ethyl acetate 35280 3600


Note: * The solvent lost during the process of solvent distillation is mainly due to organic thermal disintegration and in form of residue left behind from the bottom un-distilled product. Evaporation loss is minimized by the passage of chilled water through the condenser.


- 66 -

3.7.2 SOLVENT RECOVERY SYSTEM

1. Solvent to be recovered is transferred in to a closed, Jacketed, Vertical,

cylindrical and agitated reactor.

2. Control measure for reactor, are Temperature, Pressure and speed of agitator.

3. Reactor Jacket has all the utility connections.

4. Vapor line connected to primary condenser, where in the cooling water is

circulated. (Cooling water has the multi pass facility to achieve better heat

transfer and counter flow).

5. The system has an additional facility of reflux system.

6. The condensed liquid from primary condenser will flow to secondary condenser

by gravity, where in chilled water is circulated for further sub cooling of

recovered solvent.

7. The vent of primary condenser is connected again to the same secondary

condenser with necessary control valve system. In total secondary condenser acts

like sub cooler and as well as vent cooler.

8. The measure control for both condenser and sub cooler are pressure and

temperature both on tube side and on shell side.

9. The sub cooled solvent then flows and collects in 2 receivers, where in further

cooling is made by circulating the chilled brine. The measure control for both

receiver is the temperature and pressure in shell as well as in Jacket.

10. The vent is always from the receiver to the wet scrubber or the vacuum pump.

3.8 HAZARDOUS RAW MATERIALS USED IN THE MANUFACTURING PROCESS

The following raw materials used during the process of manufacture of APIs are hazardous in nature according to Manufacture, Storage and Import of Hazardous Chemical (Amendment) Rules, 19th January 2000, Schedule I, Part II in the table 3.6

Table: 3.6 Hazardous raw materials

Hazardous raw material Sl. No. as per Manufacture, Storage and Import of Hazardous Chemical (Amendment) Rules, 19th January 2000, Schedule I, Part II

Hydrochloric acid 313

Ethanol 248

Sodium Hydroxide 571

Potassium hydroxide 522

Methanol 377

Toluene 628

Iso Propyl Alcohol 334

Formaldehyde 295

Dimethyl Amine 215

Acetone 4

Chloroacetyl Chloride 124

Methylene chloride 400


- 67 -

3.8.1 Hazardous waste generation and its management during the manufacturing process

The hazardous wastes generated during the process of manufacture of different APIs

are stored at hazardous waste storage area and sent to authorize processers. The

quantities of hazardous waste generated from various processes are shown in the

Table- 3.7.

1. Solvent residue/ Spent Carbon

Table: 3.7 Quantity of process residue generation from solvent recovery and

Carbon waste generated from manufacturing process

Sl. No.

APIs Quantity of hazardous waste generated, kg/annum

Spent Carbon waste generated, kg/annum

1 Fexofenadine HCl Stage 1

25380 -

Stage 2 23760 -

Stage 3 17820 -

2 Ambroxol HCl Stage 1

17820 -

Stage 2 18360 1080

3 Amlodipine Besylate 11880 1080

4 Fluconazole stage 1 64260

Stage 2 16200 3240

5 Febuxostat 3468

Stage 2 4404 2244

6 Pregabalin Stage 1 8172 -

Stage 2 16560 -

7 Dabigatran 34200 -

Stage 2 26700 -

8 Verapamil HCl stage 1

38520 -

Stage 2 7200 -

9 Terfenadine 16920 -

Stage 2 18720 -

TOTAL 3,70,344 7,644


- 68 -

3.8.2 Hazardous Waste Quantity and Disposal Details

Table 3.8 Hazardous Waste Quantity and Disposal Details

Sl. no

Hazardous waste Quantity kg/annum

Disposal Details

1 Residue from the manufacturing process

3,70,344 In organic Process residue and organic waste from process is collected in HDPE Bags and sent to PCB authorized Processers for land filling

2 Spent Carbon 7,644 Spent carbon is collected in HDPE Bags and sent to PCB authorized Processers for land filling 3 Waste oil

generation from DG set

200 Collected and sent to authorized reprocessors

4 Inorganic salt from MEE.

52,800 Spent carbon is collected in HDPE Bags and sent to PCB authorized Processers for land filling 5 Used Containers 12 kg Used Containers after detoxification will be sold to authorized agents.

3.9 DOMESTIC SOLID WASTE RE-USE

The total quantity of domestic wastes generated is about 12.5 kg/day which will be segregated at source, collected in bins and composted. The composted waste will be used as manure for landscape development.

3.10 WATER, ENERGY/POWER REQUIREMENT & SOURCE

3.10.1 Water

The water demand is met from Bore well water supply. The requirement of water for the unit is for domestic, industrial purposes. Details are appended in section 3.11.1 later in the report.

3.10.2 Power

The total power requirement of the industry is 150 kVA. Further two diesel generator of 250 kVA and 15 kVA capacity is installed to serve as an alternative source of power supply to this unit.

3.11 WASTES GENERATED & SCHEME FOR THEIR MANAGEMENT/DISPOSAL

3.11.1 Water demand and wastewater/effluent discharge

Source of water supply: Bore well Total number of employees: 50 people

Per capita water demand: 40 LPCD


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The total quantity of water required for the industry is about 6 KLD. The break-up of the consumption of water is as presented below.

Table 3.9: Water Consumption and Discharge

Water consumed for Consumption (LPD)

Discharge (LPD)

(a) Domestic (toilet, canteen etc.) 2000 1800

(b) Gardening/Landscape development

350 -

(c) Industrial purpose

Process

1. RO plant and its reject 7200-5513=1687 (reject)

8873 (process effluent + Rejects) a. Process consumption 5513

2. Washing/Cleaning 1500 1500

3. Boiler feed for 2 MT boiler 3000 100 (Blow down)+ DM reject 600 a. DM plant/rejects 600

4. Cooling tower – 2 nos. 1000-800 (Condensate)= 200 (make up water)

20

5. Scrubber – 1 no. 500 500

6. R & D 150 150

Total 16300 13543 or say 13600KLD

At any given time only one product will be manufactured Note: LPD – liter per day; KLD – kilo liter per day *Start up water requirement for industrial purpose is 13950. After recycling of Evaporator condensate the fresh water requirement will be 4000 LPD. Therefore the total fresh water requirement for the project is 6.5 KLD. The treatment methods and the final disposal of each type of wastewater generated

is appended in the table 3.10 below

Table 3.10: Sewage/effluent treatment and discharge

Sewage/effluent generated from

Treatment units provided Final disposal point

(a) Domestic Treated in Septic tank Disposed to Soak pit

(b) Industrial Collection tanks of 10 KL capacity (4 No.s) are provided.

Industrial effluent is proposed to be treated in Effluent Treatment Plant with Multiple Effect Evaporator (MEE) followed by RO filtration for treatment, reuse and disposal.


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3.12 Product wise water consumption and discharge

Table 3.11: Product-wise water consumption for process and effluent discharge

Sl.NO

Products Water consumption

(L/batch)

Effluent discharge (L/batch)

No. of batches /month

Total water consumption

(L/month)

Total effluent

discharge (L/month)

1 Fexofenadine HCL

819 1140 15 12285 17100

2 Ambroxol HCL

765 816 15 11475 12240


1355.65 2202 15 20334.75 33030

4 Fluconazole 870 1314 15 13050 19710 5 Febuxostat 3401 3486 10 34010 34860

6 Pregabalin 2784 3888 10 27840 38880

7 Dabigatran 150 151 10 1500 1510 8 Verapamil 1050 1443 10 10500 14430

9 Terfenadine 681 780 10 6810 7880 Total 1,37,804.75 1,79,640

Note:

Considering no. of working days/month = 25 1. Daily water consumption from process

= 1,37,804.75/25 = 5512.19 or say 5513 LPD 2. Daily effluent discharge from the process

= 179640/25= 7185.6 or say 7186 LPD 3. Daily effluent discharge from the washings/Cleaning

= 37500/25 = 1500 LPD

3.12.1 Waste Water Characteristics Table 3.12 Waste Water Characteristics

Sl.No Characteristics

Units Values

1. pH Mg/L 6.20-6.50

2. Total Dissolved Solids Mg/L 10,500-19,500

3. Total Suspended solids Mg/L 130-180

4. Chemical Oxygen Demand Mg/L 1000-1800

5. Biological oxygen Demand Mg/L 1600-3000

6. Chlorides as Cl Mg/L <500

7 Sulphates as SO4 Mg/L <1500

8. Oil & Grease Mg/L <1.00


- 71 -

3.12.2 Treatment Scheme for Industry Waste water

11743 LPD

Screening

Neutralization

tank

Clarifier Tank

Feed

Tank

Condensate

9982 LPD

(85%)

Inorganic

Residue

176 Kg

Loss

235 LPD

MEE


- 72 -

LANDSCAPING 350 LPD

BOREWELL WATER SUPPLY

Cooling Tower bleed off 20 LPD

WATER CONSUMPTION- 6318 LPD or 6.5 KLD

DOMESTIC WATER DEMAND 2000 LPD

Scrubber

500 LPD Boiler consumption 3600-2700=900 LPD

Cooling tower Make - up water 200 LPD (1000-800 return)

Washing/ Cleaning

1,500 LPD

Scrubber effluent 500 LPD

INDUSTRIAL WATER DEMAND- 13950 LPD- Start up requirement Daily requirement after recycling from Evaporator Condensate:

13950 – 9982 = 3968 LPD or say 4KLD

RO water Plant

7200 LPD

Process consumption

5,513LPD

Domestic wastewater

1800 LPD

R&D

150 LPD

R&D effluent 150 LPD

DM tank 900 LPD

Boiler blow down

100 LPD + DM reject 600

* Process effluent & RO

rejects 8873 LPD

Washing effluent

1,500 LPD

12 KLD will be sent to Effluent Treatment Plant with Multiple Effect Evaporator followed by RO for Reuse

Loss 180 LPD

Septic tank Soak pit

Condensate, 2700


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3.13 Air Pollution Details The major air pollution sources from the industry are DG set, boiler and process sections. These sources are provided with stacks of adequate height so as to disperse the emanating flue gases containing SPM, oxides of sulfur and nitrogen without affecting the ground level concentrations and packed column scrubbers are provided to the process sections with adequate stack height as per the regulatory requirements.

The sources of air pollution, type of fuel used, fuel consumption and chimney heights for each of the air pollution sources of the project are indicated in the following table 3.13.

Table-3.13 Air Pollution Sources and Control

SI. no.

Stack attached to

Fuel used Fuel consumption

Number of

stacks

Stack/s height

Air pollution control unit

Predicted emissions

1 Process section

- - 1 15 m ARL

Packed column scrubber – 1 no.

Acid mist/ VOCs

2 Steam boiler –2 Ton capacity – 1 no.s

1 ton capacity 1 no (proposed)

Briquette 334.81 Kg/hr

167.47 Kg/hr

1 30.48 m AGL

Mechanical dust collector

SO2, NOx, SPM

3 D.G. set – 250 kVA – 1 no.

15 kVA- 1 no (Proposed)

HSD 58.75 L/hr

3 .5 L/hr

1 5 m AGL

3m AGL

Stack SOx, NOx, SPM

4 Thermic Fluid Heater (Proposed)

Briquette 75 Kgs/hr 1 10 m AGL

Stack SOx, NOx, SPM

3.13.1 Scrubbing System Details

Evacuation 750M3/Hr at Room temperature Acid Fume Capacity 25 Kg/Hr Scrubbing Media Caustic Solution/Chilled water MOC PP+FRP, body made of 3mm PP and 5mm FRP Pickings 12mm Honeycomb packing in PVC Operating Temperature Ess than 350C Blower Capacity 750M3/Hr, 2 HP Motor


- 74 -

3.4 Scrubbing System

3.14 Noise pollution details The major source of noise pollution in the industry is the DG set for which acoustic enclosure is provided. Also ambient noise levels will be ensured within the ambient standards by inbuilt design of mechanical equipment and building apart from vegetation (tree plantations) along the periphery and at various locations within the industry premises. 3.15 Solid waste details The quantity of solid waste generated from the proposed industry is detailed in the following table 3.14.

Table: 3.14 Solid Waste Generation during the Operation Phase

Total no. of employees 50

Assuming per capita solid waste generation rate as 0.25 kg/capita/day

Quantity of solid waste generated 12.5 kg/day

Organic solid waste : 60 % of the total waste 7.5 kg/day

Inorganic solid waste : 40 % of the total waste 5 kg/day

Disposal of domestic solid waste The domestic wastes are segregated at source, collected in bins and composted.


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3.16 SCHEMATIC REPRESENTATIONS OF THE FEASIBILITY DRAWING

A schematic representation of the overall feasibility and environmental assessment process is shown in Figure 3.6.

Fig 3.6: Feasibility & environmental assessment process

Significant

Not

economic

Feasibility study conducted for newly proposed industry

Statement of intent by proponent

Guidelines for EIA by SEAC/MoEF

Abandon project

Determine the coverage of the EIA - scoping

Describe the environment – baseline study

Describe the project

Identify the impacts

Evaluate the impacts

Mitigation

Preventive measures

Prepare draft EIS

FINAL EIA REPORT

CONSIDER ALL PHASES OF PROJECT –

CONSTRUCTION, DEVELOPMENT, INSTALLATION &

FINAL OPERATION/ PRODUCTION

SO

CIO

-ECO

NO

MIC

ISSU

ES

MO

NIT

OR R

EVIE

W


76

CHAPTER-4 SITE ANALYSIS

4.1 SITE CONNECTIVITY Table-4.1 Connectivity to Project Site

Sl. No.

Road Distance from the project site

(km)

Direction w.r.t. project

site

1 NH 207 1.4 North west

2 NH-4 1.7 South west

3 Dabaspet Railway station 2 North west

4 Tumkur 20 South west

5 Kempegowda International Airport, Bangalore

48 East

Fig- 4.1 Google Map Showing Connectivity to Project Site

Note: All distances mentioned are aerial.

4.2 LAND FORM, LAND USE & OWNERSHIP M/s. VPL Chemicals Pvt. Ltd., is an Active Pharmaceutical Ingredients (APIs),

manufacturing industry already established at Plot No. 64, Sompura Industrial Area,

Dabaspet, Nelamangala Taluk, Tumkur Road, Bangalore. Now the proponents intend

to expand and modify the products in the existing facility.

Dabaspet

railway station


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4.3 TOPOGRAPHY

M/s. VPL Chemicals Pvt.Ltd., is located at latitude of 13°13'29.51"N & longitude

77°15'55.85"E at an elevation of 933 m above MSL. The topo map showing the

location of the project site is appended as fig 4.2.

Fig-4.2 Topo Map

4.4 EXISTING LAND USE PATTERN

Table 4.2 Existing Land Use Pattern

Sl. No.

Particulars Details Distance from the project site

(km)

Direction w.r.t.

project site

1 Agriculture Minor activities - scattered

Beyond industrial area

-

2 National park, forest

Bannerghatta national park

60 km South east

3 Water bodies No water bodies within 5 km

Project Site


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Note: a) All distances mentioned are aerial. b) The project is a notified by KIADB, Karnataka Govt. industrial area.

4.5 EXISTING INFRASTRUCTURE

The list of existing infrastructure at the project site is 1. Water supply from Bore well 2. Power supply will be from BESCOM 3. Storm water drainage system is provided

4.6 SOIL CLASSIFICATION The soils of Bangalore Rural districts are broadly classified in to four categories viz

(i). Loamy soil (ii) Lateritic soil (iii) Lateritic gravelly soil and (iv) Red sandy soil.

Red loamy soils generally occur on hilly to undulating land slope on granite and

granite gneisses. Lateritic soil occurs in undulating terrain forming plain to gently

sloping topography of peninsular gneiss region. Lateritic gravelly soils occur in

upland regions of lateritic soils, Red sandy soil occurs in undulating land slopes.

These soils are derived from acidic rocks granites and granitic gneiss.

4.7 CLIMATIC DATA FROM SECONDARY SOURCES

Table 4.3: Meteorological Data of Bangalore for the Year 2015

Month Temperature 0C

Relative humidity

%

Precipitation rate

(mm/hr)

Atmospheric pressure

(mb)

Wind speed (m/s)

Inversion / mixing height

(m)

Cloud cover

(tenths)

Min Max Max Min Min Max Min Max Min Max Day Night Min Max

Jan 12.4 25.6 84.8 58.3 0 1.27 909 919 0 6.7 2303 2477 2 10

Feb 13.1 28.9 76.9 44.8 0 1.52 908 915 0 5.1 2517 1786 2 5

Mar 16.4 29.5 69 38.8 0 1.02 907 917 0 6.2 2798 2057 2 6

Apr 18.2 30.8 76.7 50.7 0 3.81 908 914 0 5.1 2910 1799 2 5

May 18.5 32 82.7 61.0 0 2.54 905 913 0 6.2 3319 2317 2 5

June 17.9 30.9 88.6 71.7 0 4.83 904 913 0 10.3 2828 4000 2 10

July 17.4 29.4 89 75.5 0 3.81 904 912 0 8.7 2691 3638 2 10

Aug 17 28.5 88.9 74.5 0 4.06 904 912 0 7.2 2678 2779 3 10

Sept 17.2 29.5 91.4 75.3 0 2.29 905 912 0 7.2 2802 2801 2 10

Oct 16.8 28.8 88.5 73.5 0 2.03 904 913 0 5.7 2575 2046 3 10

Nov 16.8 25.9 93.5 78.1 0 3.81 905 915 0 6.2 2177 2247 2 10

Dec 11.8 24.4 87.6 66.8 0 1.52 906 914 0 6.7 1756 2522 2 10

4.7.1 Temperature The mean maximum temperature is observed at (32°C) in the month of May and the

mean minimum temperature at (11.8°C) is observed in the month of December. In

the summer season the mean minimum temperature is observed during the month


- 79 -

of March (16.4°C). During the monsoon the mean maximum temperature is observed

to be 30.9°C in the month of June with the mean minimum temperature at 17°C

during August. By the end of September with the onset of post monsoon season

(October - November), day temperatures drop slightly with the mean maximum

temperature at 28.8°C in October and mean minimum temperature is observed at

16.8°C for both October & November. The values are presented in table 4.3.

4.7.2 Relative Humidity

Minimum and maximum values of relative humidity have been recorded. The

minimum humidity is observed to be at 38.8% in the month of March and the

maximum is 91.4% in the month of September. The mean minimum values of

humidity during summer, monsoon, post-monsoon and rainy seasons are 38.8%,

71.7%, 73.5% & 44.8% during the months of March, June, October and February

respectively. Similarly the maximum values are 82.7%, 91.4%, 93.5%, 87.6% in the

months of May, September, November & December during the summer, monsoon,

post monsoon & winter seasons. The values are presented in table 4.3.

4.7.3 Rainfall

The monsoon in this region usually occurs twice in a year i.e. from June to September

and from October to November. The maximum annual rate of precipitation over this

region ranges between 1.02 to 4.83 mm/hr.

4.7.4 Atmospheric Pressure

The maximum and the minimum atmospheric pressures are recorded during all

seasons. In the summer season, the mean maximum and minimum pressure values

are observed to be 917 mb in the month of March and 905 mb in the month of May

respectively. During monsoon season, the maximum pressure is 913 mb and minimum

904 mb. The maximum pressure during the post-monsoon season is observed to be

915 mb in November and minimum pressure is 904 mb in the month of October.

During the winter season the minimum atmospheric pressure is 906 mb in December

and the maximum is 919 mb in the month of January. The values are presented in

table 4.3.

4.7.5 Inversion Height

The maximum inversion heights at the project site during the day time & night time

for all the months of the year is as given in the table 3.1. The maximum mixing

height of 4000 m is observed during the month of June during the night time and

3319 m during the month of May during the day time. The minimum inversion heights

are 1756 m in the month of December during the day and 1786 m during the night in

the month of February.


- 80 -

4.7.6 Cloud cover

The minimum cover measured in the unit of tenths is 2 and the maximum observed

cloud cover is 10.

4.7.7 Wind

The data on wind patterns are pictorially represented by means of wind rose diagrams for the entire year as figure 4.3 (for different seasons).

Predominant wind directions

Season Period Wind direction

Summer March to May North West

Monsoon June to September East

Post monsoon October to November South West

Winter December to February North West

4.8 SOCIAL INFRASTRUCTURE Infrastructure is the basic physical and organizational structures needed for the

operation of a society or enterprise or the services and facilities necessary for an

economy to function.

The term typically refers to the technical structures that support a society, such as

roads, water supply, sewers, electrical grids, telecommunications and so forth and

can be defined as "the physical components of interrelated systems providing

commodities and services essential to enable, sustain or enhance societal living

conditions”.

Viewed functionally, infrastructure facilitates the production of goods and services

and also the distribution of finished products to markets, as well as basic social

services such as schools and hospitals; for example, roads enable the transport of

raw materials to a factory.

Table -4.4 List of Infrastructural Facilities in the Surroundings

Sl. No.

Hospital Distance from the industry

Direction w.r.t. the industry

1 Nelamangala General Hospital 19.8 South East

2 Harsha Hospital 18.8 South East

3 Manipal Hospital 20.2 North West

4 Nidavanda Govt.high school 10 South east

5 Nidavanda Railway Station 2.3 North East

6 Bangalore City Railway Station 43 South East

7 Kempegowda International Airport

48 East

Note: All distances mentioned are aerial.


- 81 -

Fig 4.3: Wind Rose Diagrams

1. March to May (summer season)

WRPLOT View - Lakes Environmental Software

WIND ROSE PLOT:

Wind rose diagram - summer season

COMMENTS:

MODELER:

M/s. Aquatech Enviro Engineers

DATE:

1/18/2012

PROJECT NO.:

NORTH

SOUTH

WEST EAST

4%

8%

12%

16%

20%

WIND SPEED

(m/s)

>= 11.1

8.8 - 11.1

5.7 - 8.8

3.6 - 5.7

2.1 - 3.6

0.5 - 2.1

Calms: 9.19%

TOTAL COUNT:

2208 hrs.

CALM WINDS:

9.19%

DATA PERIOD:

Start Date: 3/1/2010 - 00:00End Date: 5/31/2010 - 23:00

AVG. WIND SPEED:

2.73 m/s

DISPLAY:

Wind SpeedFlow Vector (blowing to)

3/1/2011

5/31/2011


- 82 -

2. June to September (monsoon season)


WIND ROSE PLOT:

Wind rose diagram - monsoon season

COMMENTS:

MODELER:


DATE:

1/18/2012

PROJECT NO.:

NORTH

SOUTH

WEST EAST

7%

14%

21%

28%

35%

WIND SPEED

(m/s)

>= 11.1

8.8 - 11.1

5.7 - 8.8

3.6 - 5.7

2.1 - 3.6

0.5 - 2.1

Calms: 1.91%

TOTAL COUNT:

2928 hrs.

CALM WINDS:

1.91%

DATA PERIOD:


AVG. WIND SPEED:

4.09 m/s

DISPLAY:



- 83 -

3. October to November (post monsoon season)


WIND ROSE PLOT:

Wind rose diagram - post monsoon season

COMMENTS:

MODELER:


DATE:

1/18/2012

PROJECT NO.:

NORTH

SOUTH

WEST EAST

4%

8%

12%

16%

20%

WIND SPEED

(m/s)

>= 11.1

8.8 - 11.1

5.7 - 8.8

3.6 - 5.7

2.1 - 3.6

0.5 - 2.1

Calms: 3.76%

TOTAL COUNT:

1464 hrs.

CALM WINDS:

3.76%

DATA PERIOD:


AVG. WIND SPEED:

3.26 m/s

DISPLAY:



- 84 -

4. December to February (winter season)


WIND ROSE PLOT:

Wind rose diagram - winter season

COMMENTS:

MODELER:


DATE:

1/18/2012

PROJECT NO.:

NORTH

SOUTH

WEST EAST

5%

10%

15%

20%

25%

WIND SPEED

(m/s)

>= 11.1

8.8 - 11.1

5.7 - 8.8

3.6 - 5.7

2.1 - 3.6

0.5 - 2.1

Calms: 2.73%

TOTAL COUNT:

2160 hrs.

CALM WINDS:

2.73%

DATA PERIOD:


AVG. WIND SPEED:

3.21 m/s

DISPLAY:



- 85 -

CHAPTER 5 PLANNING BRIEF

5.1 PLANNING CONCEPT

M/s. VPL Chemicals Pvt. Ltd., is an Active Pharmaceutical Ingredients (APIs) manufacturing industry. It is the expansion and modification project. The expansion and modification of the API’s will be done in the existing facility.

5.2 POPULATION PROJECTION

The expansion and modification will be done in existing facility no construction activity is envisaged Total no. of people employed during operation phase: 50 people

5.3 LAND-USE PLANNING

The land use planning is given in Table 5.1

Table 5.1: Land-Use Pattern

Sl. No. Particulars Area (SQM) In %

1 Total plot area 4856.23 100%

2 Hard paved area 926.23 20%

3 Landscape/Green-belt area 1500 30%

4 Built-up area 2430 50%

5.4 ASSESSMENT OF INFRASTRUCTURE DEMAND

1. National highway 207 is at 1.4 Km from project site

2. National highway 4 which connects Bangalore – Pune is at distance 1.7 km from

project site

3. The project is in designated industrial area internal roads in the industrial area

and project site is already available.

5.4.1 Water supply & sewerage infrastructure

Water demand for the industry is from Bore well.

The domestic sewage generated is treated in septic tank and sent to soak pit. The industrial wastewater is treated in Effluent treatment Plant (ETP) with MEE followed by RO filtration for treatment, reuse and disposal. 5.5 AMENITIES/FACILITIES

Proper site services such as with Drinking water, safety equipments & first Aid is

provided to the workers.


- 86 -

CHAPTER 6 PROPOSED INFRASTRUCTURE

6.1 INDUSTRIAL AREA (PROCESSING AREA)

M/s. VPL Chemicals Pvt. Ltd., is an Active Pharmaceutical Ingredients (APIs) manufacturing industry. The expansion and modification of the API’s will be done in the existing facility.

6.2 RESIDENTIAL AREA (NON PROCESSING AREA)

The non-processing area is green belt and open area.

6.3 GREEN-BELT An area of 1500 Sq.m of total plot area is green-belt/landscape development. About 50 trees of various native/indigenous variety are already planted. Another 50 trees are proposed in the expansion project

6.4 SOCIAL INFRASTRUCTURE

Details Given in Chapter- 4, section 4.8 6.5 CONNECTIVITY The site is well connected with roadways. NH-207 & NH-4 which is about 1.4 km &

1.7 km respectively.

6.6 SEWERAGE SYSTEM Sewage pipes are laid in entire company for the removal and disposal of mainly non

harmful liquid wastes from the offices and domestic waste, these liquid wastes are

sent to septic tank & soak pit.

6.7 INDUSTRIAL WASTE MANAGEMENT

The industrial wastewater is treated in Effluent Treatment Plant with Multiple Effect Evaporator followed by RO filtration for treatment, reuse and disposal. 6.8 SOLID WASTE MANAGEMENT

The domestic garbage is composted within the industry premises & the product will be used as manure for green-belt/landscape development. Hazardous solid waste will be stored in HDPE bags and sent to authorize reprocessors.


- 87 -

6.9 POWER REQUIREMENT & SUPPLY SOURCE

The total power requirement of the industry is 150 kVA which is sourced from

BESCOM. Further two diesel generator of 250 kVA & 15 kVA capacity is installed to

serve as an alternative source of power supply to this unit.

CHAPTER 7 REHABILITATION & RESETTLEMENT PLAN

M/s VPL Chemicals Pvt. Ltd. is in a designated industrial area. The expansion and

modification will be in the existing facility. No home outstees/land outstees are

expected & hence no rehabilitation plan is envisaged.

CHAPTER 8

PROJECT SCHEDULE & COST ESTIMATES

8.1 TIME SCHEDULE The time schedule for completion of the proposed project is given in the following table

Particulars Time schedule

Start of construction activity Existing plant

Completion Existing facility

8.2 ESTIMATED PROJECT COST Total capital investment on the proposed Project is detailed as under

Sl.No. Details In lakhs

1 Investment on Plant and machinery 5

2 Environment Management Budget 3

TOTAL 8

Eight Lakhs only


- 88 -

CHAPTER – 9 ANALYSIS OF PROPOSAL

Observing the demographic pattern of the study area it can be inferred that occupational pattern is a mixture more of agriculture rather industrial. The proposed project will increase the employment potential by creating direct and in-direct employment opportunities and thus be beneficial for the local and nearby populace The management of the industry gives preference to local people with both direct and indirect employment.

GOOGLE IMAGE

TOPO MAP

PROJECT SITE

, c ~',. ~.~E~B1~r1~rj~.t.."r'~'~.,~ v~.D J-"~ ~d.£l~e "t~J.,,"t«ratr . -1 0 ~

, greement made at Bangalore the Eighteenth.d~y.of anua month TwoThousand Ten between the Karnataka Industri"al Areas Development Boardhaving its Head Office at No: 14/3, 2nd Floor, Rastrothana Parishath Building,Nrupatunga Road, Bangalore-560001 represented by Sri. H S Nagarudrappa,Assistant Secretary, hereinafter called the 'lessor' (which term shall wherever thecontext so permits, mean and include its successors in interest) of the one part ANDMIs VPL Chemicals Pvt Ltd., No.27, Behind "The Club', Nayandahalli, MysoreRoad, Bangalore-560 039 represented Sri. Sasidhara Goud Patil, ManagingDirector, hereinafter called the 'lessee' (which term shall wherever the context sop~rmits, mean and include his/her/its heirs, executors, administrators, assignee andlegal representatives) of the other part.

Whereas the lessee has applied to the lessor for allotment of land for settingup of an Industrial project, a'ld in pursuance thereof, the lessor on allotment hasagreed to lease the plot of land herein described, upon terms and conditions hereincontained.

1(a) Now it is hereby agreed between the parties as follows:The lessee has paid to the lessor a sum of Rs. 68,36,840/- (Rupees Sixty eight lakhthirty six thousand eight hundred and forty only) towards the allotmentconsideration, fixed tentatively, the receipt of which is hereby confirmed by the lessor.

1(b) In consideration of the above sum and of the rent hereby reserved andperformance of covenants and conditions on the part of the lessee hereinaftercontained, the lessor hereby conveys to the lessee by way of lease a plot of landknown as Plot Nos. 64 in the Sompura I Stage Industrial Area comprised in Sy.No(s): 11-Part within the village limits of Bhartipura, Hobli Sompura, TalukNelamangala, District Bangalore admeasuring 4854.00 sqmtrs or thereabouts andmore fully described in the Schedule hereunder written and delineated on the planannexed hereto and surrounded thereon by red color boundary line, together with allrights, easements and appurtenants thereto belonging EXCEPT AND RESERVINGunto the lessor all mines and minerals in or under the said land or any part thereof

- 1 -

~.~H.S.NAGARUDRAfP A

AssistantSecretaryKarnataka Industrial Areas

Development Board,Bangalore - 560 001.~orv~rf~"

Managing Director

(hereinafter referred to as the "Schedule Property") and the lessee shall hold theSchedule Property so conveyed commencing from Twenty Sixth day of Decembermonth Two Thousand Nine on the terms, conditions and tenure herein provided.

1(c )years.

The conveyance of the Schedule Property is on lease for a period of TEN

1(d) Both during the subsistence of the lease period and also thereafter, that is duringthe interregnum between the expiry of the lease period and the execution of the saledeed, the lessee shall pay to the lessor yearly rent of Rs.1200/- (Rupees Onethousand two hundred only) and maintenance charges of Rs.3000/- (Rupees Three

~ ' .,thousand only) on the from Twenty Sixth day of December month each and every. ..

' '. year~ ~ ;' -.#.~ "I.~' <.

Pr.ovidedalways that in case the lessee fails to pay the said rent on or before thedate stipulated, the lessee shall pay to the lessor simple interest at 12.75% per annumor such other rates as may be fixed by the lessor from time to time on the rent due. Itis .'hereby agreed that expiry of lease period by itself shall not be construed asconverting the lease-hold rights into free-hold rights.

2 The lessee shall be liable to pay to the respective jurisdictional local authoritiesall existing and future taxes, rates, assessments and out goings of every description inrespect of the Schedule Property from the date on which possession of the ScheduleProperty is handed over to the lessee.

3. The lessee shall neither make any excavation in or upon any part of theSchedule Property nor it shall remove any stone, sand, gravel, clay or earth there fromexcept for the purposes of either forming foundations of building or executing any civilconstruction work or related activities in pursuance of this agreement.

. -+..4 The Lessee shall not disturb/close the valley/drain, if any, running across theSchedule property till such time a suitable alternative for the drainage with the prior

-2 -

B.S.NA~~~Assistant sccreta~

Karnataka Industrial ArcasDCII"clopment Board,Bangalore - 560 001.

F:or,VPL CHEMICALS PVT. LTD..

~".'~ ~ t.ManagingDirector

approval of the Lessor is devised and implemented. The decision of the Lessor in thisbehalf shall be final and binding on the Lessee.

5.1 The lessee shall not construct any building or erect any structure on anyportion of the Schedule Property without getting the building plans duly approved bythe lessor in accordance with the prevailing building regulations of the Board.

5.2 (i) The'(.essee shall submit the comprehensive plans for land utilization, buildings,sheds ~tc.~ in triplicate',-for prior approvalwithin one month from the date of thisagreement.

5.2 (ii) The lessee shall commence civil construction works within three months from." the date of approval of building plan and after obtaining license from the Chief. Inspector of factories and Boilers of Karnataka State and or from any other authority. as required under Law.. ~ ...

.' .1',.

. ,,",," ,~ 5.2 (iii) The lessee shall complete civil construction works, erect machineries

and commence production within twenty four months from the date of takingpossession of the Schedule Property, that is the from Twenty Sixth day of Decembermonth Two Thousand Nine after obtaining necessary licences/clearances/ approvalsfrom the concerned such as Government of India, State Government, Local Bodies,Statutory Bodies etc., wherever it is r~.quired. .';',

." ...' ,.::.; . . . t ~.6 After the construction of :buildings, the lessee shall not make any majormodifications/alterations/additions to the existing buildings/structures except with theprior approval of the lessor in writing. .

6 (a) The lessee shall maintain the Schedule Property and the buildings erectedthere on in good repairs and conditions to the satisfaction of the lessor.

6 (b) The lessee, in respect of the Schedule Property, shall observe and conform toall rules, regulations and byelaws of the local Authority concerned or any otherstatutory regulations in force relating to public health and sanitation,

- 3 -

H.S.NA~~Assistant Secretary

Karnataka Industrial AreasDevelopment Board,

Bangalore -560 001.

For VPL CHEMICALSPVT.Lru..

-'--"1. ~Managing Director

,

7 The lessee shall permit the lessor and officers, surveyors or others employedby it at all reasonable time of the day during the term hereby granted after a week'sprevious notice to enter into or upon the Schedule Property to inspect theimplementation of the project and compliance of any of the terms and conditions of thelease hereby granted.

8(a) The lessee shall use the Schedule Property only for the purpose setting up ofan industry for manufacture of Chemicals or establishing any other industrypermissible under the Law, after obtaining prior approval of the lessor, without creatingany nuisance, annoyance and disturbance to the owners, occupiers or residents ofother premises in the vicinity and the lessee shall observe and conform to rules,regulations ~nd.g!Jidelines as framed by the Department of Ecology and Environment,Karnataka Stite.. Po.llution Control Board and other competent and jurisdictionalauthoritiyit~~ard to prevention of water, air and noise pollution...

8(b) It shall be mandatory for the lessee to obtain clearance for the project fromKarnataka State Pollution control Board before commencement of approved project

9 The lessee shall keep the Schedule Property and the buildings existing thereoninsured in the name of the lessee against any damage or destruction as per thestatutory norms or in compliance with its obligations to financial institutions and bankswho may have lent moneys for the purpose of erection of factory building, plant andmachinery.

10(1) The Lessor may at its discretion extend the time for completion of civilconstruction works, erection of machineries and commencement of production afterissue of 90 days notice in terms of Sec.34-b (i) & 30 days notice in terms of 34-b(ii) ofthe KIAD Act 1966 and after consideration of the reply furnished by the lessee to suchnotice, the Lessor may extend the time for a further period of:

10(1) (a) 12 months without revising the tentative price of land if the Lessee hastaken steps to the satisfaction of the Lessor for implementation of the project and hasstarted civil construction works and has spent at least 25% of the cost towards civil

-4-

H.S.NA~~~Assistant Secretary

Karnataka Indu8trial Area.Development Board,Bangalore - 560 001.

For VPL CHE~llC1\LS PVT. LT!.J.

/. ~Managing Director

. .

,.. , -!.' IE-I -,

constructionwhich should be evidenced by a certificate of investment issued byFinancialInstitution/Bank/CharteredAccountant.

10(1) (b) At the end of the third year, a further extension of six months time bylevying an amount equivalent to 25% of the prevailing allotment price for the land atthe time of such extension after being satisfied that the lessee has invested aminimum of 25% of the project cost (excluding the land cost) which should beevidenced by a certificate of investment from the financial institutions/banks/ CharteredAccountant.

10(1) (c) Further extension of six months time by levying an amount equivalent to25% of the prevailing allotment price for the land at the time of slich extension afterbeing satisfied that the Lessee has invested a minimum of 50% of the project cost(excluding the land cost) which should be evidenced by a certificate of investment fromthe financial institutions/ banks/Chartered Accountant.

10(1) (d) No further extension shall be granted beyond a total period of four yearsfrom the date of lease-cum-sale agreement or Possession Certificate whichever islater, provided the opportunity for remedying the breach is afforded in terms of Clause-34-b(i) & (ii) of the KIAD Act. This agreement shall automatically stand terminated, ifthe lessee has not completed the civil construction work, erected machinery andcommenced production at the end of the period of four years.

10(1) (e) In the event lessee fails to take one of the effective steps as indicatedat (a), extension of time for implementing the project will be granted only on paymentof difference in land cost between the tentative cost of land at the allotted rate andcost of land prevailing at the time of grant of extension of time. If there is no upwardrevision in the tentative cost of land at the allotted rate, extension of time will begranted by levying a penalty of 10% of the cost of land at the allotted rate. Failure tofulfill any of the conditions (a) to (c) mentioned above shall result in allotment beingcancelled and agreement being terminated under clause 14. The refund of amountand forfeiture shall be in accordance with the provisions contained in the Clause 15 ofthis agreement.

- 5-

H.S.NAt~~Assistant Secretary

Karnataka Indu8trial AreasDevelopment .Board,Bangalore - 560 001.

-~w.. ".._.~._-

10(2) The lessee shall utilise not less than 50% of the schedule property and inaccordance with the proposals furnished by the lessee to the lessor in the applicationfor allotment of land and project report submitted to SHLCC/ SLSWCC/ DLSWCC/Allotment Committee.

11(1) The lessee may mortgage the lease hold righVs in the Schedule Property afterobtaining consent in writing from the lessor to secure loans for erection of building,plant and machinery on the schedule property or to avail working capital facilities forthe purposes of the project on the schedule property from financial institutions andbanks. The Lessor may consider permission to offer the lease-hold rights of thescheduled property as collateral security to financial institutions for raising loan for anyother project other than the project in this agreement, in cases where the projects arefully implemented and the land is utilized as per terms of the agreement. The decisionof the Lessor in this regard is final and binding.

11(2) Whenever the Lessee defaults in payment to financial institutions and suchfinancial institution/s, proceed against the Lessee for recovery of its dues, the Lessorreserves the right to determine the lease in accordance with Sec.34(b) of the KIAD Act1966, after giving such notice as mentioned in the lease-cum-sale agreement. Withoutprejudice to the powers of the Lessor-Board, as mentioned above, the Lessor maypermit transfer of lease-hold rights in favour of the Auction Purchaser recommendedby the financial institution/s, on payment of an amount equivalent to the differencesbetween the prevailing allotment price and the amount already paid by the Lesseeherein, to the Lessor towards the cost of land through the financial institution/soThefinancial institution/s shall be liable to pay the amount mentioned above for the Lessor-Board to consider such transfer of leasehold rights.

11(3) In case the lessee/allottee goes into liquidation or winding up proceedingswithout implementing the project fully, the lease-cum-sale agreement shall stand

terminated. N~~-6 - 8.'1.515ta'" s..rcta~Karnataka Industrial Area.

Development Board,Bangalore - 560 00 1~

For VPL CHEMICALS PVT. LJil.

---r~Managing Director

11(4) On a written request from the lessee, the lessor may permit the sub-lease of thebuilding constructed on the schedule property on such terms as may be prescribed bythe lessor from time to time after implementation of the project as approved by thecompetent authority and subject to obtaining such clearances as may be required bythe Financial Institutions / Banks. However, where the project consists of differentphases or consists of more than one building and the lessee wants to give on lease,the lessee can sub-lease such completed portion of the building with the prior approvalof the lessor even before the full implementation of the project.

12(i) The original applicanV partners/ promoter directors/ shareholders shall continueto hold a minimum of 51% interesVshareholdings in the lessee's firm/company till theend of the lease period/ execution of sale deed, whichever is later...

12(ii) The lessee shall not change- the constitution/status of itsfirm/company(proprietary or partnership (registered or unregistered) or private limitedcompany or public limited company} without the previous written consent of the lessoror any other officer authorized by the lessor and such consent shall be granted by thelessor subject to the condition that the original applicanVpartners/ promoterdirectors/shareholders should continue to hold a minimum 51% of the interesVshares inthe newly constituted firm/company till the end of the lease period/execution of saledeed, whichever is later.

Explanation: For the purpose of this Clause, the word "firm / company" means andincludes any body Corporate, like a company registered under the Companies Act,Partnership firm, Association or Society registered under the Societies RegistrationAct-1960, Trust etc.,

12(iii) In the event of lessee reducing its interest / share holdings either in the lessee'sfirm/company or in the newly constituted firm / company below 51% of the total share-holdings of the company, the lessee shall pay to the lessor a penalty or revised cost ofland as decided by the lessor from time to time in this regard, provided that suchrelaxation shall be permissible if the Lessee has substantially implemented the project.

- 7-

H.S.NA~~Assistant Secretary

Karnataka Industrial AreasDevelopment Board,

Bangalore -560 001.

For VPL CHEMICALS PVT. LTG.,

'f'. ~Managing Director

12(iv) In case of amalgamation of companies through due process of law/orders ofthe Hon'ble High Court, the successor company shall be liable to pay to the lessor, thedifference in cost of land between the allotted rate and the prevailing rate beforetransfer of lease-hold rights to the successor company.

13. In the event of the lessee's death the person to whom the title has beentransferred as heir or otherwise shall cause notice thereof to be given to the lessorwithin three months from such death. The Survivors and his/her or heirs of the allotteeconcerned would acquire the same lease-hold rights over the property, as the originalallottee had in schedule property, but only after the determination of the claims andcounter claims by the Lessor. If the claims and counter claims are of complicatednature, it is open to the Lessor to call upon the claimants and counter claimants toapproach a competent Civil Court for the purpose of getting the matter adjudicated.

14. The lessor shall be entitled to determine the lease hereby granted and to resumethe possession of the whole of the Schedule Property or any part thereof, includingexisting structures if any thereon, whenever there is breach of any of the covenantsand obligations contained herein by the lessee, after due notice to the lessee, or aftervarious stages as contemplated in the clause-10 supra are complete"

15. On determination of the lease and resumption of the scheduled property or anypart thereof, the lessor shall forfeit 25% of the allotment consideration paid togetherwith rents payable, interest due and payable on the unpaid rents and earnest moneydeposit and the residuary amount would be paid to the lessee. In such of the caseswherein the amount towards allotment consideration or part of the allotmentconsideration has been paid directly by the financial institutions / banks, to thelessor, the amounts paid by such of the financial institutions/banks towards theallotment consideration or part of allotment consideration shall be refunded to themand out of the remaining amount not exceeding 25% of the allotment considerationtogether with the rents and maintenance charges due and payable, interest due andpayable on the unpaid rents and earnest money deposit shall be forfeited to thelessor. The lessee shall not be entitled for the payment of any compensation by the

- 8 -H.S.NjJi~

Assistant SecretaryKarnataka Industrial Areaa

Development Board,Bangalore - 560 001.

For VPL CHEMICALSPVT. LTI;,

--T-~fManaging Director

lessor on account of building constructed or any improvements made on the ScheduleProperty.

Forfeiture of 25% of allotment consideration shall be limited to the area of landresumed in case of part resumption of the scheduled property.

16 Notwithstanding any such default the lessor may at its discretion extend theperiod of lease at the cost and expense of the lessee on payment of rent mentionedherein before and subject to the same covenants, provisions and stipulations hereincontained.

17. The lessor may at its discretion consider the request of the lessee for thetransfer of leasehold rights of schedule property in favour of a new entrepreneur asidentified by the lessee during the currency of lease, imposing such terms andconditions as decided by the lessor from time to time in this regard, provided that suchtransfer shall be permissible if the Lessee has substantially implemented the project.

18. The lessor may accept the voluntary surrender of schedule property by thelessee on such terms and conditions as decided by the lessor from time to time in thisregard.

For VPL CHEMICALS PVT. LTu.,

r ~

19. The lessee shall not sink bore-well on the demised premises. Any bore-wellsunk by the lessee on the demised premises unauthorisedly will become the propertyof the lessor and the same should be surrendered to the lessor within one month fromthe date of issue of notice by the lessor. If the demised premises has goodunderground sources of water, the lessor is at liberty to sink the borewell and waterrequired for the lessee's project will be supplied to the required extent through thescheme implemented by the lessor. The lessee shall have no objection to supply ofexcess water drawn from the borewell sunk on the plot allotted to it, to other plotsallotted by the Lessor. The lessee shall adhere to the terms and conditions as decidedby the lessor regarding water supply scheme from time to time.

- 9- H.S. NAf~uWAssistant Secretary

Karnataka Industrial Area.Development Board,Bangalore -560 001.

Managing Director

20(a) The lessee, in the Industrial units to be established in the schedule property,shall create maximum possible employment opportunities and provide minimum of80% of the employment to the Kannadigas on an overall basis. However, the lesseeshall reserve 100% of the jobs to Kannadigas in case of group C and D categories(persons who are living in the state for the past fifteen years and who possess theknowledge of reading and writing of Kannada are considered as Kannadigas).

20(b) The lessee, in the industrial units to be established in the scheduleproperty, shall employ only Kannadigas for the post of Personnel Officer.

20(c) The lessee, in employing skilled and unskilled labour, in the industrial units tobe established in the scheduled property, shall as far as possible give preference tothe members of the families of the landowners whose lands have been acquired forthe purpose of formation of industrial areas subject to the eligibility as perqualifications prescribed for the job.

21 The lessee shall pay the cost of additional power infrastructure if any, neededover and above the existing power infrastructure to the Indl. Area. No ObjectionCertification in favour of KPTCUBESCOMI MESCOM/HESCOM and GESCOM will beissued only after payment of additional expenditure to be incurred by the Boardtowards the cost of power infrastructure.

22 As soon as it may be convenient the lessor will fix the price of the saidpremises at which it will be sold to the lessee and communicate it to the lessee anddecision of the lessor in this regard will be final and binding on the lessee. The lesseeshall pay the balance of value of property. If any, after adjusting the allotmentconsideration and earnest money deposit excluding rents and interest and penaltiesand maintenance charges levied and paid by the lessee within one month from thedate of receipt of communication by the lessor. On the other hand, if any sum isdetermined as payable by the lessor to the lessee after adjustment as aforesaid, suchsum shall be refunded to the lessee before the date of execution of sale deed.

- 10- H.S.N~~~AssistantSecretary

Karnataka Industrial AreasDevelopment .Board.

Bangalore -560 001.

For VPL CHEMICALS PVT. LTG..

"-.-"-f'--'- ~Managing Director

23 The Lessor shall sell the schedule property to the Lessee at the end of TENyears referred to in Clause 1[C] or the extended period, if any, if the Lessee hasperformed all the conditions herein contained and committed no breach thereof. Allattendant expenses in connection with the sale, such as stamp duty, registrationcharges etc., shall be borne by the Lessee.

24 The Lessee hereby also confirm that this agreement shall be subject to theprovisions of the Karnataka Industrial Areas Development Act, 1966 (Act No: 18 of1966), the Rules and the Regulations there under.

25 If the Lessor incurs any expenditure arising from legal proceedings, whetherinitiated by the Lessor or Lessee, the expenditure shall be debited from the Lessee'saccount.

26. The terms and conditi.ons of allotment letter, dated 20.05.2009 bearingNo:IADB/HO/AS/Aliot/18236/1630/2009-10 in so far as they do not contradict thecovenants pre-cribed herein before, are to be treated as part and parcel of thisagreement.

IN WITNESS WHEREOF The Karnataka Industrial Areas Development Boardhath caused Assistant Secretary Karnataka Industrial Areas Development Board toset his/her hand and affix the official seal hereto on their behalf and the Lessee hasset his/her hand and seal thereto the day and year first above written.

SCHEDULE

(DESCRIPTION OF LAND)

for VPL CHEMICALS PVT. LTu..

"'-'7'~-"~

All that piece of land known as Plot No.64 of Sompura I Stage Industrial Areacomprised in Sy. No(s) 11-Part of Bhartipura village, Sompura Hobli, NelamangalaTaluk, Bangalore District containing by admeasurements 4854.00 Sq.mtrs. or

thereaboutsand boundedas followsthat is to say:- .~11 dy./ /- - H.S.N~J1~uRAPPA'

Assistant SecretaryKarnataka Industrial Area.

Development Board,Bangalore - 560 001.. .

Managing Director

Signed, Sealed and Delivered bySri. H S Nagarudrappa, Assistant Secretary.The Karnataka Industrial Areas Development Board,Bangalore.

H.S. NA~~~A8sjstant Secretary

Xarnataka Indultrial AreasDevelopment. Board,Bangalore - 560 001.

IN THE PRESENCE OF:

1) ~.c..e-~~~) .

~~. ~~- 'fU:~~' ~ \t..+...

2) L~~~~!ll\)~ ~r. I~"TA!) B, g~

Signed,Sealedand Deliveredby ~the above named Lessee -:~~:Y~C~EMICALS PVT LTf

Sri. Sasidhara Goud Patil, Managing Director, /A- - 1" JJ . J'M/sVPLChemicalsPvtLtd. ;<' V" ~

Managing Director

INTHE PRESE~E OF:1)

- 12-

On or towards North bv : Road NO.26On or towards South bv : Plot NO.76 & 75On or towards East by : Plot No.65

On or towards West by : Plot NO.63

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H.S.Njf~~Assistaat Secretary

Kamataka Industrial Are...Den:lopmeDt Board,Bangalore - 560 001.

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Acid Storage(1000 Ltrs x02 No.s)

PART

NO

DESCRIPTION SIZE

1Aproach road to the factory

2Material entry gate

3Security

4Visitors waiting room

5Man entry gate

6Transformer yard

7Underground storage tank

8Car parking

9

Internal roads

10Admin block(Ground floor)

11

Main stores

12Canteen above Utility block(1st floor)

13Landing platform

14

Boiler house

15Chimney

16ETP(Efluent treatment plant)

17DM water plant ( Prodn. block Terrace)

18Cooling tower( Prodn. block Terrace)

19Chilled brine plant

20

Foundation for tanks

21 Hydrogenation plant

22 Electrical panel room

23Scrap yard

24

Bore well

25API plant

26

Production block

27 Pilot plant

28QC & R&D above Admin block(1st floor)

29Future expansion above QC & R&D(2nd floor)

30Future expansion space for Utility

31Solvent drum storage yard

32Solid waste storage

33Recovered solvent storage

34

Lawn

35Safe assembly point

36 Vacuum pump

37

Rest room

38

External DG

39Occupational health centre

40 Rain water storage(50000 ltrs)

Aprox 20 mtrs

6 mtrs

2.5x5.0 mtrs

2.6x3 mtrs (HxV)

2 mtrs

4.5x4.5 mtrs

5x7 mtrs (HxV)

10x5 mtrs (HxV)

4 to 6 mtrs

18.5x12.5 mtrs

16.9x15.0 mtrs (HxV)

14.7x6.5 mtrs

4.6x6 mtrs (HxV)

6x11.4 mtrs

18 mtrs Ht.

Aprox 88 Sqm

Aprox 4x6 mtrs (HxV)

Aprox 3x3 mtrs

6.5x9.2 mtrs (HxV)

5.0x1.5 mtrs

6.7x4.35 mtrs (HxV)

Aprox 100 Sqm

2.5x4.5 mtrs (HxV)

1x1 mtrs

16.9x13.5 mtrs (HxV)

16.9x25 mtrs (HxV)

3.2x6.6 mtrs (HxV)

24.4x5.2mtrs (HxV)

6x8 mtrs (HxV)

1.6x3.4 mtrs (HxV)

6x8 mtrs (HxV)

Aprox 1100 Sqm.

Aprox 8x8 mtrs.

2.0x1.0 mtrs (HxV)

3x10 mtrs (HxV)

6x5.5 mtrs (HxV)

3.0x5 mtrs (HxV)

4x5.5 mtrs (HxV)

Up Up

Up

18.5x12.5 mtrs

18.5x12.5mtrs

NORTH

All dimensions are in mm unless mentioned otherwise

R2

REV

41 Security 22.8x3.0 mtrs

BOILER H

OUSE

PROJECT REPORT - Environmental Clearance

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