NEW PRE FEASIBILITY REPORT US AMINO PVTenvironmentclearance.nic.in/writereaddata/Online/TOR/15_Nov_2017... · The partners of the company have good experience in handling the production

PRE FEASIBILITY REPORT

OF

M/S- US AMINO PVT. LTD. Aaraji No. 588 Village- Ladana, patwar mandal- Vasani kala Tehsil- Mavali

Dist.- Udaipur (Raj.)313205

FOR

BULK DRUGS UNIT

Page 20 of 51

Pre-Feasibility Report

1.0 EXECUTIVE SUMMARY

M/S- US AMINO PVT. LTD. was incorporated to produce bulk drugs at registered address Aaraji

no. 588 Village- Ladana, patwar mandal- Vasani kala Tehsil- Mavali Dist.- Udaipur (Raj.)313205.

The company proposes for expansion of its bulk drug and intermediate manufacturing capacity in

same premises.

S. NO PARAMETER DESCRIPTION

1. Category of

Project as per

EIA Notification

&Amendments

5(f) “A” (Proposed project located outside the notified

industrial area)

2. Project cost for

Expansion

85.0 lacs

3. Plot area 4129.00 SQM

4. Existing

Products

S.

No.

Product Existing

capacity

(TPA)

Expansion

Proposed

(TPA)

Total

(TPA)

1 Carnitine

Tratrote

60.00 MT - 60.00 MT

2 Cystine 12.00 MT - 12.00 MT

3 L- Lysine

HCL

240.00 MT - 240.00 MT

4 N-Acetyl L

cystine

60.00 MT - 60.00 MT

5 Proposed

products

S.

No.

Product Proposed Capacity

(TPA)

1 Methotrexate 6.0 MT

2 Rosuvastatin calcium 2.4 MT

3 Telmisartan 12.0 MT

4 Sucralfate 6.0 MT

5 Arteemether 6.0 MT

6 Arteether 6.0 MT

Page 21 of 51


6. Resources

I Electricity

Requirement

Existing 90 KVA Proposed 60 KVA

Total – 150 KVA

Source of

electricity

Ajmer Vidyut Vitran Nigam Limited, Rajasthan

D. G. Sets

(Stand by)

Existing :

1. 62.5 KVA

Proposed: Nil

II Water

consumption

Existing : 4.5 KLD

Proposed : 3.5 KLD

Total: 8.0 KLD

Source of water By Tanker (out sourcing)

Waste water

generation

Existing 1.9 KLD Proposed 2.4 KLD

Total- 4.3 KLD

Mode of disposal Zero Discharge System

III Boiler Existing :

1. Baby boiler (0.6 TPH)

Proposed- Nil

IV Fuel Existing:

1. 1.5 lph HSD

2. WOOD BRIQUETTES -100 KG/ Hr

6. Solid waste

generation

Existing:

1. Spent carbon- 0.59 MT/Annum

Proposed: 1. ETP Sludge- 1.0 MT/Annum

S.

No

Name of the Solid

Waste

Disposal Method

1. Spent carbon CTDF Udaipur

2. ETP Sludge

CTDF Udaipur

7. Nearest Highway State Highway No. 9 - (1.0 KM) North

8. Nearest Railway

Station

Fatehnagar- 5.0 KM

9. Nearest Air Port Maharana Pratap Air Port (Dabok)- 30.0 KMs

Page 22 of 51


2.0 INTRODUCTION OF THE PROJECT/BACKGROUND INFORMATION

2.1 Identification of Project and Project Proponent

S. No. Name of partner

1 Mr. Rajesh Vora

Director

Experience in Bulk drugs Sales- APP.-25 Years

2 Mr. Nitin Kumawat

Managing Director

Mob: +919414555529

The partners of the company have good experience in handling the production management,

financial management and all the allied areas.

2.2 Brief description of nature of the project-

M/s – US AMINO PVT. LTD is Directorship concern and proposed project was established

as Bulk Drugs Manufacturing Unit on Feb. 2015 and registered under the District Industries

Center (DIC) at Khasara no. 588 Village- Ladana, Patwar mandal-Vasni Kala Tehsil-

Mavali Dist. Udaipur, Rajasthan. Rajasthan State Pollution Control Board had issued the

Consent To Operate vide letter No. file no. : F(Tech)/Udaipur(Mavli)/2561(1)/2015-

2016/1808-1809, Copies of the same are attached.

2.3 Need for the project and its importance to the country and or region-

The Company proposed products is essential for human body and must be supplied in the

diet and disease. The project is being set-up for expansion in production capacity by addition

of few new products in existing production plant. The technology is totally proven and safe

in all aspects. The project will help industrial development in the region. Various products

have export potential and will help in own’s economy by generating foreign exchange and

also will be increase employment opportunities in the region. This project will help the

MAKE IN INDIA concept in our own small way.

2.4 Demands-Supply Gap.-

Importance and day to day requirement

Competition in the Indian Chemical market swelled in recent years, with increasing generic

compounds introduction in the domestic market. The price of the products has reduced

substantially which led to less supply of high profit margin products in the market. A

demand- supply gas is created due to less supply of products. To capture this newly created

gap between demand and supply in the domestic market company wishes to introduce low

margin products.

Page 23 of 51


2.5 Imports Vs Indigenous production

Main primary Raw material available in domestic market and rare raw material will be

Import from outside.

2.6 Export Possibility- In this time huge possibility of export of API

The company has great demand from existing as well as new clients for expansion products

in domestic market. Some of the company’s APIs will be exported to Europe, Japan, South-

East Asia and Middle East countries which will generate foreign exchange for the country.

2.7 Domestic/export Markets-

The finished goods will be sold in domestic market primarily and it would be exported to the

Regulated International Market as per demand.

2.8 Employment Generation (Direct and Indirect) due to the project

At present the company has – 09 employees. We have a strong team of manufacturing,

Quality Control and Quality Assurance chemist.

The Details of employment for expansion of product in this unit shown in below

Table.

TABLE 2.1: EMPLOYMENT REQUIREMENTS FOR EXPANSION

Particulars No. of employees Functional Area

Key managerial staff 3 Finance, Marketing, Production, Quality

control, R&D, Logistics etc

Administration 2 Office work

Skilled and semi-

Skilled

15 Production Process, Maintenance,

stores, Safety.& Un skilled workers

Total 20

3.0 PROJECT DESCRIPTION

3.1 Type of Project

M/s US Amino Pvt. Ltd. Proposes new products for expansion in the existing premises

situated at Khasara no. 588 Village- Ladana, patwar mandal- Basani kala Tehsil- Mavali

Dist.- Udaipur, Rajasthan. The proposed project is categorized under category B of 5 (F)

{Synthetic Organic Chemical Industry (dyes & dye intermediates; bulk drugs and

intermediates excluding drugs formulations; synthetic rubbers; basic organic chemicals,

other synthetic organic chemicals and chemical intermediates)}.

3.2 Location

The site coordinates are

Latitude: N240 47’ 23.85”

Longitude: E 740 03’ 34.10”

Page 24 of 51


Fig. 3.1 Location Map Satalite Image

Page 25 of 51


Fig 3.2 Key plan of proposed project on G.T. Sheet

3.3 Details of alternate sites considered

It’s an expansion project in existing premises.

3.4 Size or magnitude of operation

M/s Us Amino Pvt. Ltd. wants to make new products within existing premises. The

proposed enhance production are shown in table 3.1

Page 26 of 51


Table 3.1: Existing product quantity

S. No. Product Existing capacity

1 Carnitine Tratrote 60.00 MT

2 Cystine 12.00 MT

3 L- Lysine HCL 240.00 MT

4 N-Acetyl L cystine 60.00 MT

Table 3.2: Proposed new product quantity

S. No. Product Proposed Capacity

(TPA)

CAS Number

1 Methotrexate 6.0 MT 59-05-2

2 Rosuvastatin calcium 2.4 MT 147098-20-2

3 Telmisartan 12.0 MT 144701-48-4

4 Sucralfate 6.0 MT 54182580

5 Artemether 6.0 MT 71963-77-4

6 Arteether 6.0 MT 75887-54-6

3.5 Project Description with Process Detail

1. METHOTREXATE

Structure

IUPACE NAME (2S)-2-[(4-{[(2,4-Diaminopteridin-6 yl)methyl] (methyl) amino}

benzoyl) amino] pentanedioic acid

Molar mass - 454.44 g/mol

BRIEF MANUFACTURING PROCESS FOR METHOTREXATE

Methotrexate is manufacturing in two step reaction.

1. Hydrolysis

2. Purification

1. Hydrolysis: - Methotrexate ester is hydrolysis with Sodium hydroxide in presence of

acetone as solvent after completion of reaction crude Methotrexate obtained.

2. Purification: - Crude Methotrexate is dissolve with Methanol and heat the mass and

add carbon and filer the mass and cool the mass up to crystallization then centrifuge and

dried and packing.

Page 27 of 51


Methotrexate ester Sodium Hydroxide

Page 28 of 51


PROCESS FLOW CHART METHOXATRATE

Production Qty. / Month-500kg

Batch Size in Kg – 100kg

No. of Batches per Month - 5

Methoxatrate ester (1000kg) Acetone (2850kg) Loss (150kg)

Acetone (3000kg) Methoxatrate Acid sulary (3100kg)

Water (2000kg)

HCL 10%(100 KG)

Sodium Hydroxide 10% Soln. (100kg) Methoxatrate sulary (3200 kg.)

Methoxatrate Acid sulary (3100kg)

Methoxatrate sulary (3200 kg.) Methoxatrate wet cacke-1260 kg

Waste water-1940 kg

Methoxatrate wet cacke-1260 kg DRY METHOXATRATE-900 KG

Water Evoporated-360 kg

Acidification

Neutralization

Centrifuge

Drying

Milling

Store

Packing

Page 29 of 51


MATERIAL BALANCE METHOXATRATE

1st Stage

S.No Input Out put

1. Methoxatrate ester (1000kg) Acetone (2850kg) Loss (150kg)

2. Acetone (3000kg) Methoxatrate Acid sulary (3100kg)

3. Water (2000kg)

4. HCL 10%(100 KG)

6100kg 6100 kg.

2nd

Stage

S.No Input Out put

1. Methoxatrate Acid sulary

(3100kg)

DRY METHOXATRATE-900 KG

2. Sodium Hydroxide 10% Soln.

(100kg)

Water loss- 360 Kg

Waste water1940 kg. (Sodium chloride

soln.)

TOTAL-3200 Kg 3200 Kg

2. ROSUVASTATIN CALCIUM

Molecular Formula- C44H64CaF2N8O12S2

Molecular Weight- 1001.14

Route of Synthesis

Rosuvastatin calcium is manufactured by Rosuvasatatin ester and Calcium chloride

and Tolune as a solvent

Page 30 of 51


3

C O Ca

CH H

O N

N

CH3

N N H3C

H C

OH OH O

Pg - 3

ROSUVASTATIN CALCIUM CONDENSATION

F

OH OH O

N O Na

H C CaCl2

SO2CH3 CH3

sodium (3R,5S,E )-7-(4-(4-fluorophenyl)-6-

isopropyl-2-(N-methylmethylsulfonamido) pyrimidin-5-yl)-3,5-dihydroxyhept-6-enoate

Chemical Formula: C22H27FN3NaO6S

Molecular Weight: 503.52

F

CH3 SO2CH3

SO2CH3 CH3

F

calcium (3R,5S,E )-7-(4-(4-fluorophenyl)-6-isopropyl -2-(N-methylmethylsulfonamido)pyrimidin

-5-yl)-3,5-dihydroxyhept-6-enoate

Chemical Formula: C44H54CaF2N6O12S2

Molecular Weight: 1001.14

(ROSUVASTATIN CALCIUM)

C

N N

H CH

+ 3

H C 3 N N 3 O OH OH

Page 31 of 51


FLOW CHART ROSUVASTATIN CALCIUM

Production Qty. / Month-200kg


No. of Batches per Month – 4

Rosuvastatin Ester (1430 KG) TOLUNE (760 L) LOSS-40 L

METHANOL(300 ) METHANOLIC SOLN. OF ROSUVASATATIN (2460 KG)

TOLUNE (800L)

HYDRCHLORIC ACID 0.3 N (230 L)

SODIUM HYDROXIDE(500.00 KG)

METHANOLIC SOLN. OF ROSUVASATATIN (2460 KG)

HYDRCHLORIC ACID 0.3 N (100 L ) METHANOL(285 L)

. Calcium chloride Soln. (670 l) Rosuvastatin calcium sulary (2945l)

Rosuvastatin calcium sulary (2945l)

DM WATER (400L) Waste Waste Water (1495 l)

Wet Cacke Rosuvasatatin (1450 kg)

Wet Cacke Rosuvasatatin (1450 kg) SU Dry Rosuvasatatin Calcium (1000 KG)

WATER EVOPORATE-450 KG

Crystallization

Centrifuge

Drying

Milling

Packing

Store

Page 32 of 51


MATRIAL BALANCE ROSUVASTATIN CALCIUM

Batch Size in Kg 270

Production per month in kg 200

No. of Batches per month 01

Name of the Input Quantity

In kg Name of the out put

Quantity

in Kg

Rosuvastatin ester 1430.00 Rosuavasatatin calcium 1000.00

Hydrochloric acid 0.3 N 330.00 Solvent Recovery

Sodium hydroxide Soln. 5% 500.00 Toluene 760.00

Toluene 800.00 Methanol 285.00

Methanol 300.00 Solvent loss

Calcium chloride 270.00 Toluene 40.00

DM Water 800.00 Methanol 15.00

Waste Water 2230.00

Total 4430.00 4430.00

3. TELMISARTAN

IUPAC name

2-(4-{[4-Methyl-6-(1-methyl-1H-1,3-benzodiazol-2-yl)-2-propyl-1H-1,3-benzodiazol-1-

yl]methyl}phenyl)benzoic acid

CAS Number - 144701-48-4

Formula C33H30N4O2

Molar mass 514.617 g/mol

Manufacturing Process

2-n-Propyl-4-methyl -6(1-methyl benzimidazole-2-yl) benzimidazole (RM-I) is treated with

methyl-4’-(bromomethyl)-biphenyl-2-carboxylate (RM-II) presence of Methyl iso butyl

ketone as solvent .and Potassium hydroxide to form 4-[4’-methyl - 6- (1- methyl-1H-

benzimidazole-2yl-2-propyl-1H-benzimidazole-1-ylmethyl] biphenyl-2-carboxylic acid

methyl ester which is hydrolyzed with sodium hydroxide in aqueous to give Telmisartan is

purified in metylene di chloride.

Page 33 of 51


N N

O O

N

CH3

N CH3

Chemical Reaction

CH3

KOH, IPA,

RT, 3 hrs

CH3

N

N

CH3

N H

4’-

Bromomethylbiphenyl-2-

carbonitrial

M.W.272.14

CH3

2-n-Propyl-4-methyl-6-(1’-

methylbenzimidazole-2-yl)

benzimidazole

MW 305.0

Telmisartan methyl ester

Methyl 4'-((1,4'-dimethyl-2'-

propyl-2,6'-bi(1H-benzo

[d]imidazol)-1'-

yl)methyl)biphenyl-2-

carboxylate

KOH, IPA, 800C,30 mins.

CH3

N N

N

CH3

MW 514

O OH

N CH3

N CH3

Page 34 of 49


PROCESS FLOW CHART TELMISARTAN

MIBK (2400kg) MIBK (2160kg) Loss (240kg)

Potassium Hydroxide (760kg) Stage-I (1238kg)

RM-I (825kg) Waste Water (6707L)

Water (5000 L) Water evaporation losses-

500 L

RM-II (760kg)

Stage-I (1238kg) N-Butanol (5580kg) Loss (620kg)

N-Butanol (6200kg) Stage-II (1115kg)

Sodium Hydroxide (1060kg) Waste Water (9133L)

Hydoro Chlorice Acid (1000kg) Water evaporation losses-500 L

Water (7450L)

Stage-II (1115kg) Telmisartan Sulary (9465KG)

Methylene di chloride (5600 kg) MDC (5040 kg) Loss (560kg)

Acetic Acid (600kg)

Water (7450L) Ammonia Soln.(300 kg)

Telmistran sulary (9465 kg) Waste water (7765 l)

Telmistran wet cake(1700

kg)

Steam

Telmistran wet cake(1700) Dry Telmistran (1000kg)

Evaporation losses-700 l

Condensation

Oxidization

Crystallization

Centrifuge

Drying

Milling

Packing

Store

Page 35 of 49


MATERIAL BALANCE TELMISARTAN

1st STAGE

S.no Input Out put

1. 2-n-Propyl-4-methyl-6-(1’-methylbenzimidazole-2-yl) -

825 kg benzimidazole (RM-I)

Methyl iso butyl

ketone(2160kg) Loss (240kg)

2. 4’-Bromomethylbiphenyl-2-carbonitrial -

760kg

Stage-I (1238kg)

3. Potassium Hydroxide (760kg) Waste Water (6707L)(KBR

SOLN. SOLID BY SOLAR

EVOPRATION)

4. Methyl iso butyl ketone (MIBK) (2400kg) Water losses in drying-500 L

5 Hydro chloric acid (1100 kg)

5 DM Water ( 5000L)

TOTAL 10845 kg 10845 kg.

II STAGE

S.no Input Out put

1. I -STAGE MATERIAL-1238 KG N-Butanol (5580kg) Loss

(620kg)

2. N-Butanol (6200kg) Stage-I I (1115kg)

3 Sodium Hydroxide (1060kg) Waste Water (sodium chloride

soln.PH 6.5 TO 7.0) (9133L)

4. Hydoro Chlorice Acid (1000kg) Water losses in drying-500 L

5 DM Water (7450 L)

TOTAL-16948 KG 16948 KG

III STAGE

Sno Input Out put

1. I I -STAGE MATERIAL-1115 KG PURE TELMISARTAN-1000

KG

2. Methylene di chloride-5600 kg.

3 Ammonia soln.-300 KG Methylene chloride -5040 KG

4. Acetic Acid-600 KG Water losses in drying-400 L

5 DM Water 5500 L Waste water(Ammonium acetate-

5975 L

6 EVOPORATION LOSSES-700 L

TOTAL-13115 KG 13115 KG

Page 36 of 49


4. SUCRALFATE

CHEMICAL FOURMLA-C12H64Al16O7S8

MOLECULAR WT.-2086.75

Sucralfate Route of Synthesis Sucrose is reacted with chlorosulfonic acid in pyridine and Ammonium Hydroxide

get Ammonium Salt which is reacted with Aluminum chloro hydrate to get the

required product.

OH

8

OSO2ONH3

8

Chlorosulfonic acid

Py

Sucrose

40 to 45oC

Aluminium chloro hydrateOSO2OAl(OH)2

8RT, 12hr

NH3

Sucralfate

Page 37 of 49


FLOW CHART & MATERIAL BALANCE Production Qty. / Month-500kg


No. of Batches per Month – 1

SUCROSE (200kg) SUCRAL FATE AMMONIUM

SALT(630 kg)

PYRIDINE(500kg) PYRIDINE(475kg) loss(25kg)

CHLOSULPHONIC ACID (560kg) Waste Water(290kg)

AMMONIUM HYDROXIDE(160kg)

SUCRAL FATE AMMONIUM SALT(630 kg) . . . SUCRALFATE (2444 KG)

ALUMINIUM CHLOROHYDRATE (814kg)

WATER (1000kg)

.

SUCRALFATE(1400kg) WET CACKE Waste Water(1044kg)

SUCRALFATE WET CACKE-

1400 KG

SUCRALFATE WET CACKE-1400 KG SUCRALFATE DRY -1000 KG

WATER EVOPORATE-400 KG

Condensation

Oxidization

Centrifuge

Drying

Milling

Packing

Store

Page 38 of 49


MATERIAL BALANCE SUCRALFATE

I STAGE

S. No INPUT OUT PUT

1. SUCROSE-

200 kg

SUCRALFATE AMMONIUM SALT -

630 kg

2. PYRIDINE

500 kg

PYRIDINE-

475kg loss -25 kg

3. CHLOSULPHONIC ACID

560 kg

WASTE WATER

290 L

4. AMMONIUM HYDROXIDE

160 kg

TOTAL 1420 kg 1420 KG

II STAGE

S. No INPUT OUT PUT

1. SUCRAL FATE AMMONIUM

SALT -630 kg

SUCRALFATE DRY-

1000 KG

2. ALUMINIUM CHLOROHYDRATE-

814 kg

WASTE WATER-

1044 L

3. WATER

1000 L

WATER EVOPORATE-

400 L

TOTAL- 2444 KG 2444 KG

5. Artemether

BRIEF MANUFACTURING PROCESS

Charge DHAM ( Dihydroarte misnin ) along with methanol and catalyst in

reaction vessel, check for TLC and if ok add water directly in the vessel to separate

the crude product; after filtration and drying the crude product is purified with

methanol, dried and packed. Final product obtained.

Page 39 of 49


FLOW CHART & MATERIAL BALANCE FOR ARTEMETHER

DI HYDROMISNIN (1110 KG) METHANOL(4950)

LOSS(550) METHANOL (5500kg)

MDC+HYDROMISNIN(6860 KG)

SODIUM BORO HYDRIDE( 155 )kg

DM WATER(4000L) WASTE WATER(4155

L )

Methylene chloride(5750 KG)

MDC +HYDROMISNIN(6860 KG) MDC5175 KG+

LOSS 575 KG

TRI METHYL ORTHO ACETATE (1100 KG) ARTHEMETHER

SULARY 7710 KG METHANOL 3500 KG + LOSS 1000 KG

METHANOL 5000 KG

DM WATER 5000 L

ARTHEMETHER SULARY 2950 KG ARTEMETHER WET

CACKE 1400 KG

WASTE WATER

(1550 KG)

ARTEMETHER WET CACKE (1400 KG) ARTEMETHER DRY

1000 KG

WATER EVOPORATE

400 KG

Reduction

CONDENSION

Centrifuse

Drying

Milling

Store

Page 40 of 49


Material balance

I STAGE

S.No Input Out put

1. DI HYDROMISNIN 1110 KG METHANOL 4950 KG LOSS 550 KG

2. METHANOL 5500 kg MDC+ HYDROMISNIN 6860 KG

3. Water 4000 L WASTE WATER 4155 L

4. SODIUM BORO HYDRIDE 155 kg

5 Methylene chloride 5750 KG

TOTAL 14515 kg 14515 KG

II STAGE

S.No Input Out put

1. MDC+ HYDROMISNIN 6860 KG MDC (R)-5175 KG + LOSS-575 KG

2. TRIMETHYL ORTHO ACETATE

1100 KG

ARTEMETHER -1000 KG

3. METHANOL 5000 KG METHANOL-3500 KG+ LOSS-1000

4. WATER 5000 L WATER EVOPORATION LOSS-400 L

5. WASTE WATER 6310 KG

TOTAL- 17960 KG 17960 KG

6. Arteether

BRIEF MANUFACTURING PROCESS

Charge DHAM ( Dihydroarte misnin ) along with ethanol and catalyst in reaction

vessel, check for TLC and if ok add water directly in the vessel to separate the crude

product; after filtration and drying the crude product is purified with methanol, dried

and packed. Final product obtained.

Page 41 of 49


FLOW CHART & MATERIAL BALANCE FOR ARTEETHER

DI HYDROMISNIN (1110 KG) METHANOL(4950) LOSS(550)

METHANOL (5500kg) MDC+HYDROMISNIN(6860 KG)

SODIUM BORO HYDRIDE( 155 )kg

DM WATER(4000L) WASTE WATER(4155 L )

Methylene chloride(5750 KG)

MDC+HYDROMISNIN-6860 KG METHYLENE CHLORIDE+ ARTEETHER LAYER-6750KG

ETHANOL -3330 L WASTE WATER 6250 KG

PARA TOLUNE SULPHONIC ACID-310 KGS

WATER 2500 L

METHYLENE CHLORIDE+ ARTEETHER LAYER-6750KG METHYLENE CHLORIDE-5175+LOSS 575 KG

REDUCTION

DISTILITION

PACKING

STORE

Page 42 of 49


Material balance

I STAGE

S.No Input Out put

1. DI HYDROMISNIN 1110 KG METHANOL 4950 KG LOSS 550 KG

2. METHANOL 5500 kg MDC+ HYDROMISNIN 6860 KG

3. Water 4000 L WASTE WATER 4155 L

4. SODIUM BORO HYDRIDE 155 kg

5 Methylene chloride 5750 KG

TOTAL 14515 kg 14515 KG

II STAGE

S.No Input Out put

1. MDC+ HYDROMISNIN 6860 KG MDC (R)-5175 KG + LOSS-575 KG

2. ETHANOL - 3330 L ARTEETHER -1000 KG

3. PARA TOLUNE SULPHONIC ACID-

310Kgs

WASTE WATER 6250 KG

4. WATER 2500 L

5.

TOTAL- 13000 KG 13000 KG

3.6 Raw materials required with estimated Quantities

S.No. Chemicals Quantity /Month (In KG)

1. Methoxatrate ester 555.5

2. Acetone 1666.67

3. Hcl 10% 55.5

4. Sodium hydroxide 10% soln. 55.5

5. Rosuvastatin ester 286

6. Hydrochloric acid 0.3 n 66

7. Sodium hydroxide soln. 5% 100

8. Toluene 160

9. Methanol 8060

10. Calcium chloride 54

11. 2-n-propyl-4-methyl-6-(1’-methylbenzimidazole-2-yl) -

benzimidazole (RM-I)

825

12. 4’-bromomethylbiphenyl-2-carbonitrial 760

13. Potassium hydroxide 760

14. Methyl iso butyl ketone (MIBK) 2400

15. Hydro chloric acid 1100

Page 43 of 49


16. N-butanol 6200

17. Sodium hydroxide 1060

18. Hydoro chloric acid 1000

19. Methylene di chloride 5600

20. Ammonia soln. 300

21. Acetic acid 600

22. Sucrose 100

23. Pyridine 250

24. Chlosulphonic acid 280

25. Ammonium hydroxide 80

26. Aluminium chlorohydrate 407

27. Di hydromisnin 555

28. Sodium boro hydride 77.5

29. Methylene chloride 5750

30. Trimethyl ortho acetate 550

31. Di hydromisnin 555

32. Sodium boro hydride 77.5

33. Ethanol 1665 liter

34. Para tolune sulphonic acid 155

3.7 Resource optimization – Utilize & Recycling

The plant will work to optimize the resource utilization. The domestic and RO reject water

will be recycled and reused which reduce water requirement significantly. There will be

recover ≥96% solvent and unit will follow solvent guideline.

3.8 Availability of water and its source, Energy/Power requirement

3.8.1 Water

Water requirement of the project for domestic and industrial activity during operation phase

will be 8.3 KLD. The water requirement will be met through outsourcing.

Table 3.3: Water Requirement

S. No. Purpose Water Requirement in KLD

Existing Proposed Total

1. Process 2.50 1.5 4.0

2. Laboratory 0.25 0.25 0.5

3. Boiler Make up 1.0 1.0 2.0

4. Cooling towers Make

up

0.25 0.25 0.50

5. Domestic Usage 0.5 0.50 1.00

Total 4.5 3.5 8.0 KLD

Page 44 of 49


Water balance

3.8.2 Power Requirement

Ajmer Vidyut Vitran Nigam Limited (AVVNL), Rajasthan.

3.8.3 Fuel Requirement

For boilers:- Wood fire 20 MT. /Month

DG sets ;- HSD 200 LPM

3.9 Quantity of wastes to be generated (liquid and Solid)

Proposed unit already works on Zero Liquid discharge system, therefore no effluent will

generated.

Water consumption

Fresh water – 8.0 KLD

DM

Plant –

4.0

Utility

2.5

Domestic

Usage 1.0

Laboratory

0.5

Boiler

Make up

2.0

Cooling

towers

Make 0.5

up

ETP

3.7 KLD

Dispose

through

soak pit

0.6 KLD

Process waste

water – 1.8

KLD

DM Waste

water 1.3

KLD

Boiler blow

down 0.1 KLD Cooling

tower waste

0.1 KLD

Loss in Drying

0.9 KLD

Laboratory

W/W 0.4

After treatment used

in plantation

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3.9.1 Waste Water Generation and utilization

Table 3.5: Wastewater generation and Treatment Method

S. No Unit

Effluent Generation in KLD Treatment

Method Existing Proposed Total

1 Process waste 0.50 1.30 1.8

Through ETP

(3.7 KLD)

2 Laboratory 0.2 0.2 0.4

3 DM Waste 0.8 0.5 1.3

4 Boiler Blow down 0.05 0.05 0.10

5 Cooling tower

waste

0.05 0.05 0.10

6 Domestic Usage 0.30 0.30 0.60 Through Soak

pit

Total 1.9 2.4 4.3 KLD

3.9.2 Solid waste generation and Disposal

Table 3.6: Solid waste generation and Disposal

S. No. Name of the Solid

Waste

Total Quantity Disposal Method

1 Spent Carbon 0.59 MT/Annum CTDF, Udaipur

2 ETP Sludge 1.0 MT/Annum CTDF, Udaipur

Gaseous emissions & control

Flue gas emissions

There will be flue gas emission from one boiler and one DG set. The fuel consumption detail

and air pollution control measures are covered in below table.

Page 46 of 49


Sr. No. Stack

Attached

To

Stack

Height (m)

Type of Fuel Air

Pollution

Control

Measures

Parameter

1 Baby Boiler

30 MTR Wood

Briquettes

Cyclone Dust

Collector

PM

SO2

NOX

2 D.G. Set

Diesel - PM

SO2

NOX

3.10 Schematic representations of the feasibility drawing which give information of EIA

purpose.

The applicability of the S.O 1533 for the proposed project was explored by

considering different possibilities & provision made in the said notification.

Considering the products & project location of the proposed project it is noticed that the

proposed project falls under Category 5 (f) “A” of the Schedule-I of EIA Notification

SO 1533 and its amendments.

As per the provision of the SO 1533, it is necessary to get Environmental Clearance by

applying to Moef.cc, New Delhi along with the Environmental Impacts Assessment

Study Report for the proposed project prior to commissioning of the project

activities.

Therefore, the EIA is required to conduct to comply with provisions of SO 1533 made for

Category 5(f) “A” of schedule –I of the notification.

4.0 SITE ANALYSIS

The project proponent did not consider any other alternative site for proposed project.

4.1 Connectivity

Nearest Highway- State Highway-9 (1.0 KM) North

Nearest Airport- Dabok Udaipur Airport (30.0KM) South west

Nearest Railway station- Fatehnagar 5.0 KM North East

The nearest habitation from the site is Basani, Basni kala, Fatehnagar.

4.2 Land Form, Land use and Land ownership.

The land is registered by the name of “US Amino Private Limited”. The area where unit is

proposing expansion is already used for industrial activity and is almost flat terrain. The

total land area of the project is 4129 SQM and due to expansion there will be no additional

land acquired.

Page 47 of 49


4.3 Topography

The topography of the study area is mostly plain and gradually slopes towards east. There

will be no change in topography of area due the proposed project.

4.4 Existing Land use pattern

Table 4.1 Land Use Pattern

S No. Particulars Area Sq. M Percentage

1 Total Plant Area 615 14.89

2 Total Garden and Plantation Area 3017 73.1

3 Roads & Open Area 497 12.02

Total 4129 SQ. M. 100%

Fig. 4.1 Plant Layout

Page 48 of 49


4.5 Existing Infrastructure

Proposed expansion project has the basic Infrastructure there. The existing plant has capacity

to produce expanded quantity of product and there is no requirement of additional

infrastructure for the said expansion.

5.0 PLANNING BRIEF

Proposed plant activities will start after getting statutory clearance form related authorities.

The project will complete within one year. Further proposed project activities will take

care of all the rules and regulation of statutory authority and provide the control

measure and devices to achieve the standard norms.

6.0 Corporate Social Responsibilities:-.

The applicant shall spend 1.0 lacs/ Annum for five years for the development of the area. It is

proposed to provide drinking water facility in surrounding villages and schools by hand

pump/dug well/water tank, health camps and free medicine clothes distribution to poor

villagers.

6.1 Amenities /Facilities

Education- schools including middle, secondary and higher secondary schools, social welfare

hostels. Medical and Health- Community Health Centre, & Primary Health center are

available near villages.

6.2 Connectivity

The project site is very well connected by road through State Highway no. 9 and

Southern railways.

6.3 Drinking water Management

All the villages are electrified and drinking water facilities are extended to all villages.

6.4 Social Infrastructure available

Well-developed social infrastructure facilities are available at nearby habitations.

6.5 Power Requirement & Supply/Source

All the villages are electrified and drinking water facilities are extended to all villages.

7.0 REHABILITATION AND RESETTLEMENT (R & R) PLAN

Rehabilitation & Resettlement (R&R) plan is not require to proposed project.

Page 49 of 49


8.0 PROJECT SCHEDULE & COST ESTIMATES

8.1 Likely date of start of construction and likely date of completion

Construction is not required because the proposed expansion will be executed in existing

infrastructure. Proposed project activities will be started after getting statutory

clearance from related authorities.

Environment clearance 31st March, 2018 Consent to establish and consent to operate by 31st

April, 2018

Start production from 1th

June, 2018

8.2 Estimated Project Cost along with analysis in terms of economic viability of project

Proposed activity will provide benefits to the local people in terms of financial and

social welfare. Project cost for the proposed Expansion projects is Rs.85 lacs which includes

the cost of new plant machinery.

9.0 ANALYSIS OF PROPOSAL (FINAL RECOMMENDATIONS)

• Local people will get direct financial benefit by way of employment.

• Local people will get some contracts of supply and services to get indirect

income.

• Company will contribute in improving education and health facilities in nearby area.

Documents

NEW PRE FEASIBILITY REPORT US AMINO PVTenvironmentclearance.nic.in/writereaddata/Online/TOR/15_Nov_2017... · The partners of the company have good experience in handling the production