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Enaltec Labs Pvt. Ltd. August 2017

Sadekar Enviro Engineers Pvt. Ltd. Page 1

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Plot No-825/826, Pitampur Industrial Area, Sector - III Dist:Dhar, -454775Madhya Pradesh, India.

EIA Consultant

M/s. SADEKAR ENVIRO ENGINEERS PVT. LTD.

QCI – NABET accredited EIA consultancy for schedule 5(f) Cat.-‘A’Certificate No – NABET/EIA/1518/RA 020

NABL Accredited Laboratory, Valid up to 29.06.2018Lab. Recognized by MoEF& CC, GOI, Valid up to 2.01.2019

Certified by ISO 9001:2008 & BS OHSAS 18001:2007

310, Dempo Towers, EDC Patto, Panaji, Goa state, India. PIN: 403001Email :[email protected] / [email protected]

Web site:-www.sadekarenviro.com Telephone :0832-2437048/2437164



Table of Content

Sr. Title Page no.1 Executive summary 32 Introduction of the project 43 Description of Project 64 Site Analysis 245 Planning 266 Proposed infrastructure 277 Rehabilitation and resettlement 298 Project schedule and cost estimation 299 Analysis of proposal 29



1. Executive summary

Salient Features of ProjectName & Address of Company M/s Enaltec Labs Pvt. Ltd.

Plot No-825, 826, Pitampur Industrial Area, Sector - IIIDist:Dhar, Madhya Pradesh, India. Pin Code - 454775.

Schedule of project as per EIANotification, 2006

5(f)

Category of Project 'B1'Total Plot Area Components Area in sq. m.

Total plot Area 8581.1Built up area 5084.84Parking area 333.6Green belt 2530.01

Production details Total capacity: 190.284 MT/A

Water Requirement of Project Source : MP AKVNTotal water Requirement : 143 CMD

Bore well water will be used, in case of non availability ofwater from MPAKVN.

Effluent generation Industrial effluent – 40.3 CMDDomestic Effluent – 7.2 CMD.The project will function as a ZLD unit.

Effluent treatment Plant A full fledged ETP with MEE followed by ATFD and R.Oplant will be installed. The treated effluent will be entirelyrecycled within the plant premises. The domestic effluentwill be treated in the aeration tank of the ETP.

Power Requirement ElectricityElectricity Supplied – Madhya Pradesh Electricity Board.Total Connected Load – 1700 KVA.Total Power Requirement – 1150 KVA.

Boiler Details Steam Boiler1. Capacity - 850 Kg/Hr

Fuel Type - Furnace Oil2. Capacity – 1000 Kg/Hr

Fuel type - BriquetteFuel requirement Furnace Oil : 1.5 T/Day

Briquette : 3.0 T/dayHSD: 130 Lit/Hr

D.G. Set 625 KVAScrubber Acid & alkali scrubber will be installed of capacity 1200

CMH.Man power Construction Phase - 100-150

Operational Phase – 18 workers per day ( 60 workers pershift)

Project Cost (Rs.) Total: 494 Lakh.



2. Introduction of the project

2.1 Identification of Project & Project Proponent:

The proposed facility will be setup for manufacturing Active Pharmaceutical Ingredients

(API) to the tune of 190.284 Tonnes/Annum at Pitampur Industrial Area, which is a notified

Industrial area. Thus the project falls in Schedule 5 ‘f’ and Category – ‘B1’ as per the EIA

Notification and its subsequent amendments. Public hearing is exempted for the said project as

per MoEF & CC OM dated 10th December 2014 for projects/ activities located in Notified

Industrial Areas. The Project Proponent has applied to EAC (Industrial Projects - 2), MoEF &

CC, GOI as the tenure of MP SEIAA and SEAC has been completed dated 29.06.17. As per

the Notice vide no – 974/SEIAA/2017 of the MP SEIAA, All the project proponents are

requested to approach the MOEF & CC, GOI in absence of MP SEIAA.

Enaltec was established in 2006 by a group of young and experienced professionals with the

specific objective to develop and produce complex, small volume, technology driven products

at competitive prices, thus providing the critical India advantage to generic formulators across

the world. The company has other units in the country which are US-FDA approved and

WHO GMP certified. The proponent will maintain similar standards and practices in the

proposed unit at Pitampur.

The company is aware about its social responsibilities, the company has designated a share of

2% of its total profit towards CSR activity provisions as per the section 198 of the Companies

Act, 2013.

2.2 Brief description of nature of the project:

The project involves manufacturing API products which are used for various therapeutical

properties. The molecules will be synthesized in house at the facility through different process

which are designed to give maximum purity to the product. The common operations involved

are distillation, centrifugation, drying, filtration, miling, sifting, blending which are essential

for isolation and formulation of the desired project. These chemical reactions undergo at

specified temperatures, thus utilities like boilers, cooling towers and brine plants are required

to bring about the change in temperatures. The unit will generate pollution mainly in the form

of air emissions, effluents from the industrial process and solid wastes from the different

operations. All the required mitigation measures will be implemented to the keep the pollution

level with the pollution levels within limits.



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

Active pharmaceutical ingredients are the active substances that are used in the manufacture

of a drug and have a pharmacological effect. They provide health benefits and play a vital role

in disease diagnosis, prevention, and treatment. Active pharmaceutical ingredients may be

synthesized either chemically or through biotechnological methods.

The Indian pharmaceutical industry ranks among the top five countries based on the

production volume and accounts for about 8.5 per cent of global production and the turnover

has increased from about US$ 0.3 billion in 1980 to about US$ 18 billion last year whereas,

the estimated world market value of US$ 53 billion. Low cost of skilled manpower and

innovation are some of the main factors supporting this growth. India is the third largest active

pharmaceutical ingredient (API) market in the Asia-Pacific region and China is its main

competitor.

Due to the ever increasing pollutions levels and changing living conditions which has caused

increase in stress related disease, better diagnostic facilities have been important drivers for

the growth of the industry.

Government Initiatives like MAKE IN INDIA, Increasing public expenditure on health care

segment under Health care Policy and 100 % FDI for Pharma Industries will ensure a

significant growth in the coming years.

2.4 Demand supply gap:

The project is envisaged to meet the demand supply gap in both domestic market and export

market as API demand is increasing day by day, Enaltec Labs is supplying the API to cater to

the needs of national and international markets. Currently the company exports its drugs to

USA and other major European Countries. Elaborating on the need for the project, the report

states that the growing population needs lifesaving drugs for better health care resulting in

increase of manufacturing better substitute drugs from time to time.

2.5 Imports vs Indigenous Production

The main competitors for these products are Chinese markets.

2.6 Export Possibility

The products will be exported to Middle East and SAARC Countries

2.7 Domestic/Export Markets

The products have growing demand in Indian as well as International markets.



3. Description of Project3.1 Project type

The proposed project is a new activity wherein a new plot has been purchased by the project

proponent along with some existing structures and utilities. The plot has been purchased from

Namokar Speciality Chemicals Pvt. Ltd. The registration of the unit has been done at Plot no –

825 & 826, Pitampur Industrial Area Sector – III, District – Dhar, State – Madhya Pradesh has

been done with Madhya Pradesh Audyogik Kendra Vikas Nigam Indore Ltd. The copy of

lease deed and sale deed are attached as Annexure – 4.

3.2 Location

Company is located at Plot no. 825 & 826, Pitampur Industrial Area Sector – III, District –

Dhar, State – Madhya Pradesh. The geographical co – ordinates of the plant boundary are

given below :

Sr. No Latitude Longitude

1 22°37'14.72"N 75°34'23.87"E

2 22°37'17.35"N 75°34'23.94"E

3 22°37'17.37"N 75°34'20.23"E

4 22°37'14.73"N 75°34'20.22"E

The plot is surrounded by M/s Dupont Rubber towards north direction. There are vacantplots in the west and south directions. Internal AKVN road runs parallel in the eastdirection.

Some of the important industries near the project site are –1. Dupont rubber.2. Epoc Pharma3. Shivangi Sariya4. Parsahuram Puria



The google Image of the plant boundary is shown below -

Fig - Google Image showing location of the plant on Google Earth

Google Earth Image showing 10 km radial distance from the study area

Fig – 10 km radial distance from project site.



The sensitive features and important locations within the 10 km study area are tabulatedbelow –

Sr. No Description Details and distance in kms.1 Nearest Town Pitampur – 9.63 Kms.2 Nearest Habitation Sagore Village – 3.22 Kms.3 Nearest Railway Station Beyond 10 kms from the study area.4 Nearest Wildlife Sanctuary/

National ParksThere are no wildlife sanctuaries /national parks within the 10 km radialdistance from the project site.

5 Reserved Forests /Protected Forests Betma Reserve Forest – 6.10 kms fromthe project site.Bhawargad Protected Forest – 11.2 kmsfrom project site.

6. Inland, coastal, marine, orunderground waters

Pond near Dhureri Village – 8.32 kmaway from project site.Sanjay Jalashay – 10.32 kms fromproject site.Kishanpura Talab – 9.5 kms from Projectsite.Angrer river – 2.83 kms from Project site

7 Other Features There are stone quarries at a distance of6.15 km in the NEE Direction and 5.81kms in the SEE direction.

3.3 Details of alternate sites considered

No alternative sites were examined.

3.4 Size of operation

The proposed project is set up for a capacity of 190.284 MT/A. The total raw material

requirement is 678.15 MT/M. The detailed product and raw material list is given at 3.5. The

project is set over an area of 8581.1 sq. mtr. The total built-up area is 5084.84 sq. mtr.

3.5 Project description with process detail.

Production Details

The product list is tabulated below –

Sr.No. Name of the products Production Quantity /Annum

1 Atorvastatin 300002 Dexketoprofen 120003 Montelukast 120004 Dapoxetine 12005 Losartan potassium 2400



6 Glimepiride 18007 Desloratidine 60008 Escitalopram 60009 Febuxostat 12000

10 Lymecyclin 1200011 Moxifloxacin 3600012 Nitazoxanide 2400013 Risperidone 120014 Topiramate 600015 Rupatadine 360016 Rosuvastatin 1200017 Alcaftadine 618 Bromfenac sodium 6019 DarifenacinHydrobromide 3620 Dronedarone Hydrochloride 36021 Oxcarbazepine 120022 Solifenacin succinate 2423 Tazarotene 6024 Clonidine HCL 1225 Dimethyl fumarate 12026 Flavoxate hydrochloride 12027 Fluvoxamine maleate 12028 Olmesartan Medoxomil 60029 OlopatadineHCl. 1230 Pramipexole dihydrochloride 1231 Roflumilast 1232 Tolperisone HCL 120033 Cinacalcet hydrochloride 8434 Clopidogrelbisulfate 600035 Dalfampridin 1236 Milrinone 637 Nepafenac. 4838 Olanzapine. 60039 Pitvastatin Calcium 12040 Teriflunomide. 12041 Tetrabenazine 18042 TimololMeleate 12043 Trospium chloride 30044 Brimonidinetartarate 12045 Agomelatine. 12046 PrasugrelHCl. 300



The detailed raw material list is tabulated below :-

Sr. No Raw Material Qty MT/Month

Physical andchemical

composition

Sourceof supply Transport

14R,Cis)-1,1-dimethylethyl-cyanomethyl-

2,2-dimethyl- 1,3-dioxane-4-acetate2.500 solid Import

by air androad

2 Methanol 128.000 liquid Local by road

3 Hydrochloric acid 6.439 liquid Local by road

4 Sodium hydroxide 1.790 solid Local by road

5 Raney nickel 0.970 solid Local by road

6 MTBE 4.760 liquid Local by road

7 Aqueous ammonia solution 1.700 liquid Local by road

8 Calcium acetate 0.500 solid Local by road

9 Hyflo 11.100 solid Local by road

10 Pivalic acid 0.250 liquid Local by road

11 Cyclohexane 25.060 liquid Local by road

12 Isopropyl alcohol 77.710 liquid Local by road

13 Ketoprofen 2.220 solid Importby sea / By

Air/road14 N-octyl-D-Glucamine 1.790 solid Import by sea

15 Toluene 74.530 liquid Local by road

16 Ethyl Acetate 107.980 liquid Local by road

17 Tri Buffer 0.340 liquid Local by road

18 Diol Intermediate 2.000 liquid Local by road

19 Mesy1 Chloride 0.550 liquid Local by road

20 DIPEA 0.900 liquid Local by road

21 MDC 85.780 liquid Local by road

22 Mercapto Intermediate 1.400 liquid Import by air/road

23 Dimethy Sulphoxide 24.620 liquid Local by road

2425% Sodium Methoxide solution in

methanol2.260 liquid Local by road

25 Aqueous 40% Sodium hydroxide 2.400 liquid Local by road

26 Acetic Acid Solution 12.8 % 0.100 liquid Local by road

27 n-Heptane 1.100 liquid Local by road

28 Pet ether 12.640 liquid Local by road

29 Activated Charcoal 0.650 solid Local by road

30 Benzene 0.074 liquid Local by road

31 Aluminium chloride 0.122 solid Local by road

32 3-chloro propionyl chloride 0.104 solid Local by road

33 Sodium bi carbonate 1.037 solid Local by road

34 Sodium Sulfate 0.183 solid Local by road

35 S-methyl oxazaboralidine 0.007 solid Local by road

36 Hydrogen Peroxide 0.024 liquid Local by road

37 Sulfuric acid 0.203 liquid Local by road

38 α-naphthol 0.086 solid Local by road



39 Potassium carbonate 1.727 solid Local by road

40 Tetrahydrofuran 12.812 liquid Local by road

41 Triethylamine 3.400 liquid Local by road

42 Di-methyl amino pyridine 0.059 solid Local by road

43 Methane sulfonyl chloride 0.365 liquid Local by road

44 Di-methyl amine solution 0.142 liquid Local by road

45 Acetonitrile 0.957 liquid Local by road

462-butyl-4-chloro-1-[p-(o-1H-tetrazol-

5ylphenyl) benzyl]imidazole-5-methanol0.210 solid Local road

47 Acetone 26.960 liquid Local by road

48N-(4-[2-(3-ethyl-4-methyl-2-oxo-3-

pyrroline-1-carboxamide-ethyl]-benzenesulfonamide

0.199 solid Local by road

49 Trans-4-methyl-cyclohexyl isocynate 0.105 liquid Local by road

50 Loratadine 0.660 solid Local by road

51 Sodium Hydroxide pellets 1.620 solid Local by road

52

4-[4-(dimethylamino)-1(4-fluorophenyl)-1-hydroxybutyl]-3-

(hydroxymethyl)benzonitrile Di-P-Tolulyl-D-Tartarate


53 Para toluene sulphonyl chloride 0.245 solid Local by road

54 oxalic acid 0.087 liquid Local by road

55Ethyl-2(3-cyano)-4 Isobutoxyphenyl} 4-

methyl-5-Thiazole carboxylate.1.250 solid

Local /Import

by road /byair

56 Lithium Hydroxide 0.260 solid Local by road

57 L-lysine HCl 0.430 solid Local by road

58 Formaldehyde 0.227 liquid Local by road

59 Gati ester 4.650 solid Importby sea / By

Air

60 Nonane 1.680 liquidLocal /Import

by air/road

61 Zinc chloride 0.060 solid Local by road

62 Boric acid powder 0.990 solid Local by road

63 Acetic anhydride 9.338 liquid Local by road

64 Asiprin 3.040 solid Local by road

65 DMF 0.062 liquid local by road

66 SOCI2 2.239 liquid local by road

67 Nitro Comp 1.600 solid Importby sea / By

Air

686-Fluoro-3-(4-piperidinyl)-1,2-benzisoxazole hydrochloride


693-(2-chloroethyl)-2-methyl-6,7,8,9-

tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one HCl


70 TBAB 0.037 solid Local by road

71 Sodium chloride 2.230 solid Local by road

72(3as,5aR,8bS)-2,2,7,7-

TETRAMETYHYL TETRAHYDRO-0.715 solid Local by road



3aH-bis[1,3]DIOXOLO[4,5-b:4,5' -a]PRYAN [-3a-YL] METHANOL

73 Desloratadine 0.300 solid In House In House

743-(Chloromethyl)-5-methylpyridine

hydrochloride0.204 solid In House In House

75 Acetic acid 0.354 liquid Local by road

76(4R-cis)-[(Acetyloxy)-methyl]-2,2-

dimethyl-1,3-dioxane-4-aceticacid-1,1-dimetyl ethyl ester (KSM)

2.500 solid Import by air/road

77N-[5-(bromo methyl)-4-(4-fluoro

phenyl)-6-isopropyl pyrimidin-2-yl]-N-methyl methane sulfonamide.TPP salt

4.290 solid Local road

786,11-dihydro-11-(4-piperidinyl)-5H-imidazo-[2,1-b][3]benzazepine (e)-2-

butenedioate(1:2)0.005 solid local by road

79 Paraformaldehyde 0.051 solid Local by road

80 Thiophene 0.000 liquid local by road

81 Palladium carbon 0.001 solid local by road

82 Formaldehyde solution (37-41%) 0.008 liquid Local by road

83 Chloroform 0.025 liquid Local by road

84 Manganese dioxide 0.008 solid Local by road

85 Methyl ethyl ketone 0.588 liquid Local by road

86 2-Amino-4-bromobenzophenone 0.013 solid local by road

87 Ethyl-α-(methylthio)acetate 0.009 solid Import by air/road

88 t-Butyl hypochlorite 0.007 solid In House In house

893-(S)-(+)-(1-Carbamoyl-1,1-

diphenylmethyl)pyrrolidine-L-(+)-tartrate

0.005 solid In House In House

905-(2-Bromoethyl)-2,3-

dihydrobenzofuran0.003 solid Import by air/road

912-butyl-5-nitrobenzofuran-3-yl)(4-hydroxyphenyl)methanone

0.035 solid Importby air / bysea/road

92N-butyl-N-(3-chloropropyl) butan-1-

amine0.022 solid Import by air/road

93 10 methoxy iminostilbene 0.123 solid Import by air/road

94 Sodium cynate 0.071 solid Local by road

95 Glacial acetic aicd 0.389 liquid Local by road

96(1S)-1-phenyl-1,2,3,4-Tetrahydroisoquinoline


97 Ethyl chloroformate 0.001 solid Local by road

98 R-(-) Quinuclidinol 0.002 solid Local by road

99 Succinic acid 0.001 solid local by road

100 Triphenyl phosphine 0.001 solid Local by road

101 6-ethynyl-4,4-dimethylthiochromane 0.007 solid Local road

102 Ethyl 6-chloronicotinate 0.007 solid local by road

103 Cuprous iodide 0.000 solid Local by road

104 1,4 dichlorobenzene 0.003 solid Local by road

105 Benzoyl Chloride 0.012 liquid Local by road



106 Ammonium Thiocyanate 0.002 solid Local by road

107 Methyl Iodide 0.004 liquid Local by road

108 Isoamyl alcohol 0.031 liquid Local by road

109 3-methylflavone-8-Carboxylic acid 0.011 solid Import by air/road

110 1-(2-hydroxy ethyl ) piperidine 0.005 solid Import by air/road

1115-Methoxy-1-[4-(trifluoromethyl)

phenyl]-1-pentanone0.009 solid Import by air/road

112 Hydroxylamine Hydrochloride 0.005 solid Local by road

113 2-chloroethylamine Hydrochloride 0.006 solid Local by road

114 Maleic Acid 0.009 solid Local by road

115 PEG-400 0.004 liquid Local by road

116 Trityl Olmesartan 0.091 solid Local by road

117(11-oxo-6,11-dihydrodibenzo[b,e]

oxepin-2-yl)acetic acid0.005 solid Import Air/road

1183-(brooms(triphosphorany)-N,N-

dimethylpropan-1-amine.HBr0.031 solid Import Air/road

119(S)-4,5,6,7-tetrahydrobenzo[d]thiazole-

2,6-diamine0.002 solid Local by road

120 Propionaldehyde 0.001 liquid Local by road

121 Sodium borohydride 0.002 solid Local by road

1223-(cyclopropyl methoxy)-4-

(difluoromethoxy)benzoic acid0.002 solid Import by air/road

123 3,5-dichloro-4-pyridinamine 0.002 solid Import by air/road

124 4'-Methyl propiophenone 0.074 solid local by road

125 1,3 Dioxolane 0.119 solid local by road

1263- 3-(trifluoromethyl)phenyl

propionaldehyde0.014 solid local by road

127 (R)- (+)-1-(1-Naphthyl)ethylamine 0.010 solid local by road

128 Pyridine 1-oxide hydrochloride 0.002 solid In House In House

129 Fuming Nitric acid 0.002 liquid Local by road

1301-ethoxy-2-(4-pyridinyl)ethenyl methyl

ketone0.001 solid local by road

131 Malononitrile 0.004 solid Local by road

132 Amino benzophenone 0.009 solid Import by air/road

133 N-Chlorophthalimide 0.009 solid Local by road

134 2-(Methylthio)acetamide 0.007 solid In House In House

1352-Methyl-4- Piperazine 1-yl-10-H-Thieno [2,3,6][1,5] Benzediapene

0.059 solid Local By road

136

Ter-butyl 2-((4R, 6S)-6-((E)-2-(2-cyclopropyl-4-(4-flurophenyl) quinolin-3-yl) vinyl-2, 2-dimethyl-1,3-dioxan-4-

yl)acetate

0.012 solid Import Air/road

137 Disiopropyl ether 4.116 liquid Local by road

138 Calcium Chloride dihydrate 0.003 solid Local by road

1395-methyl-N-(4-(trifluoromethyl) phenyl)

isoxazole-4-carboxamide0.011 solid Import Air/road

140 6,7-dimethoxy-3,4-dihydroisoquinoline. 0.050 solid In House In House

1413-((Dimethylamino)methyl)-5-

methylhexane-2-one iodomethane0.101 solid in house In House



142 Reducer 0.390 liquid Local by road

1434-(4-(((5S)-3-tert-butyl-2-

phenyloxazolidin-5-yl) methoxy)-1, 2, 5-thiadiazol-3-yl) Morpholine

0.011 solid local by road

144

3-(2-hydroxy-2,2-diphenylacetoxy)spiro[bicycle3,2,1]octane-8,1-pyrrolidin]-1-

ionchloride

0.028 solid Import by air/road

145 6-amino 5 bromo quinoxaline 0.020 solid Local by road

146 Benzoyl Chloride 0.012 liquid Local by road

147 Ammonium thio cyanate 0.008 solid Local by road

148 Bromobenzene 0.195 liquid Local by road

149 Ethylene diamine 0.018 Local by road

150 L(+) Tartaric acid 0.007 liquid Local by road

1512-(7-methoxynaphthalen-1-

yl)acetonitrile0.013 solid Import Air/road

152 Hydrogen Gas 0.010 Gas Local by road

1532-bromo-1-cyclopropyl-2-(2-

fluorophenyl)ethanone0.063 solid In House In House

1545,6,7,7a-tetrahydrothieno[3,2-c]pyridin-

2(4H)-one HCl0.044 solid Local road

155 IPA.HCl(13%) 0.232 liquid Local by road



Details of Manufacturing Process:

Moxifloxacin Hydrochloride

Brief Description of Manufacturing Process:

Stage-A1-cyclo propyl-6,7 di fluoro-1,4 dihydro-8methoxy4-oxo-3-quinoline carboxylic acid ethylester reacts with Boric acid, Zinc chloride to give Stage-A.

Stage-BStage-A reacts with [S,S]-2,8- Diazabicyclo-[4,3,0] Nonane in presence of Triethyl amine,Methylene dichloride to give moxifloxacin complex further hydrolysis with Conc. HCl inIsopropyl alcohol to give Stage-B.

Stage-FinalStage-B further purified in Methanol, Isopropyl alcohol, Conc. HCl and Acetone to give pureform of.

Route Synthesis

N

O

OH

O

F

O

CH3

N

HN

HCl

Triethylamine

Acetone

Stage-B

Moxifloxacin Hydrochloride

HN

NH

N

O

F

O

CH3

O

N

B-OO

O+

O

CH3

O

CH3

HN

N

O

OH

O

F

OCH3

N

HN

HCl

HCl

N

OO

F

OCH3

OEt

F

N

O

F

OCH3

O

F

B-OO

O+

O

CH3

O

CH3

Stage-A

Boric acid

(1-cyclo propyl-6,7 di fluoro-1,4 dihydro-8methoxy4-oxo-3-quinoline carboxylic acid ethyl ester)

Chemical Formula: C16H15F2NO4Molecular Weight: 323.29

2,2-diacetoxy-6-cyclopropyl-8,9-difluoro-7-methoxy-4-oxo-4,6-dihydro-2H-[1,3,2]dioxaborinino[5,4-c]quinolin-1-ium-2-uide

Chemical Formula: C18H16BF2NO8Molecular Weight: 423.13

NonaneChemical Formula: C7H14N2Molecular Weight: 126.16

HCl

MethanolPurified water

1-cyclopropyl-6-fluoro-8-methoxy-7-((4aS,7aS)-octahydropyrrolo[3,4-b]pyridin-6-yl)

-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochlorideChemical Formula: C21H25ClFN3O4

Molecular Weight: 437.89

H2O

Chemical Formula: C21H24FN3O4.HCl.H2OMolecular Weight: 455.90



Mass balance:



Mass Balance in Moles

Sr.No.

InputComponent Mol wt

AmountIn Kg Moles

MolarRatio Remark

Existingconsumption

MT/Day

Proposedconsumption

MT/Day

Totalconsumption

MT/Day

1 Gati ester 323.29 1.55 4.795 1Startingmaterial

0 155 155

2 Nonane 0.56 Solvent 0 56 56

3Methylenedichloride

9.44 Solvent 0 944 944

4 TEA 101.19 0.56 5.53 1.15 Solvent 0 56 56

5 Zinc chloride 136.286 0.02 0.15 0.03 Reagent 0 2 2

6 Methanol 3.61 Solvent 0 361 361

7 Charcoal 0.14 0 14 14

8 Conc HCl 0.85 Reagent 0 85 85

9 Acetone 1.50 Solvent 0 150 150

10Boric acid

powder61.831 0.33 5.34 1.11 Reagent 0 33 33

11Acetic

anhydride102.09 3.10 30.3653 6.3327 Reagent 0 310 310

12 Hyflo 0.03 0 3 3

13Isopropylalcohol

5.38 Solvent 0 538 538

The manufacturing process of other major products is attached as Annexure – 3.



3.6 Resource optimization ( recycle/ reuse)

The process will be designed to achieve maximum conversion rate of raw material to

products.

The plant will be operated as a ZLD unit, wherein the treated effluent will be entirely

recycled/ reused within the plant premises.

The Mother Liquor and solvent mix will be sent to the authorized recyclers/ reprocessors

for recovery.

The spent catalyst will be sent to the authorized recyclers/ reprocessors for recovery.

The discarded drums and containers will also be sent to authorized recyclers.

Provision for Rain Water Harvesting will be done, so as to harness the rain water.

3.7 Availability of water, energy fuel

Sr.No

Particular Source Quantity

1 Water MPAKVN. There is aborewell in the plant sitewhich will be used inabsence of water supplyfrom MPAKVN.

143 CMD

2 Energy MP Electricity Board Connected Load – 1700 KWTotal Power Requirement – 1125KVA

3 Fuel Local Vendor Furnace Oil – 1.5 T/DayBriquette – 3.0 T/DayDiesel – 130 L/Hr (For D.G Set,only operated during powerfailure)



Water balance calculations for expansion unit

Components

ProposedConsumption

Proposed Losses Raw Effluent in CMD

(CMD) (CMD) (Before treatment)Domestic Industrial

Domestic 9 1.8 7.2 --Process 16 -- -- 16Equipment cleaning 14 14Boiler 37 36 -- 1

Cooling Tower 61 51.7 -- 9.3

Garden 6 6 -- --

Total 143 CMD 95.5 CMD 7.2 CMD 40.3 CMD

Total Effluent Generated: Industrial – 40.3 CMD + Domestic – 7.2 CMD = 47.5 CMD

The plant will function as a ZLD unit the entire effluent will be recycled and reused by means of a full fledged ETP with MEE followed by ATFD and

R.O plant.



3.8 Quantity of waste to be generated

1. Hazardous waste

HW will be stored separately in demarcated area and disposed to CHWTSDF as perthe Hazardous And Other Wastes (Management and Trans-boundary Movement)Rules, 2016. The details are tabulated below -

Sr.No

Particulars CategoryProposedTPM

Method of Disposal

1Hyflo and carbonwaste

28.3 1.5 To CHWTSDF

2 Spent Solvent 28.6 555 To the authorized recycler3 Process/solid waste 28.1 5 To CHWTSDF

4 Catalyst waste 28.2 1.5 To authorized recycler

5 Spent Oil 5.1 0.2 To CHWTSDF

6 Distillation residue 36.1 5 To CHWTSDF

7Off specificationproducts

28.5 0.1 To CHWTSDF

8Date expiredproducts

28.5 0.1 To CHWTSDF

9 ETP Sludge 35.3 3 To CHWTSDF10 MEE Residue 37.3 82 To CHWTSDF11 Discarded containers 33.1 1 To authorized recycler

2. Non hazardous waste

Sr. No Particulars TPM Method of Disposal

1Plastic waste, plastic

wrappers, scrap0.1

Sold to approved scrap dealers

3. Effluent generation:

Domestic effluent generation: 7.2 CMD

Process effluent: 16 CMD

Equipment Washing : 14 CMD

Cooling tower blowdown: 9.3 CMD

Boiler blowdown: 1 CMD

Total Effluent generation after expansion: 47.5 CMD.



Effluent Treatment Scheme:

For High COD/TDS Stream:

High COD/TDS Effluent

Oil & Grease Trap

Collection cum EqualizationTank

Flash Mixer

Flocculator

Primary Settling Tank

MEE Feed Tank

MEE with ATFD (40-42KLD)

MEE Condensate Tank

Sent to ETP for furtherTreatment

Sludge Tank

Dewatered Sludge fordisposal

RO reject Tank

CIP Tank

Solids Out

Solids for disposal

Sludge

Acid & Lime Dosing System

Poly Dosing System

Stripper (30KLD)Solvents

Alum Dosing System



For low COD/TDS Stream:

Low COD EffluentDomestic Sewage

Flash Mixer

Oil & Grease Trap

Flocculator

Collection cum Eq.Tank

Septic Tank

Primary Settling Tank

Aeration Tank

Sec. Tube Settler

Polishing Tank

Pressure Sand Filter

Activated Carbon Filter

Sludge DewateringSystem

Sludge for disposal

RO Feed Tank(To RO for Further Treatment)

Excess sludge

Excess sludge

Sludge re-circulation

Sludge Tank

Flash Mixer

Flocculator Clarifier

Caustic

Alum & Poly

Alum & Poly

Acid & Lime

MEE Condensate



3.10 Schematic Representation of the Feasibility Drawing of EIA

PRODUCTION ACTIVITY

RESOURCE CONSUMPTION(WATER)

POWER CONSUMPTION

WASTEGENERATION

FINISHED PRODUCTS

MARKET

ECONOMY

EMPLOYMENT

RAW MATERIAL

POLLUTIONABATEMENT

CLEANENVIRONMENT



4. Site Analysis

4.1 Connectivity

The project is located in Pitampur Industrial area, Sector - III is easily connected to Mhow

Gatabillod road by internal roads provided by MPAKVN which is further connected to NH-3

(Mumbai – Agra Highway)

Nearest Railway Station: Haranya Kheri Railway Station, approximately at a distance of

21.3 km.

Nearest Airport: Indore Airport ( Devi Ahilyabai Holkar Airport, Indore) approximately at a

distance of 260.3 km.

Location and Access

The industrial area is centrally located and easily accessible through all modes of transport.

Road: Easily connected to Mhow Gatabillod road by internal roads provided by MPAKVN

which is further connected to NH-3 (Mumbai – Agra Highway)

4.2 Land Form, Land use and Land Ownership

The land is owned by the MP AKVN and the lease deed has been executed with M/s Enaltec

Labs Pvt. Ltd. The Project location & the surrounding environs being located in the notified

industrial area prevails industrial land use form. In the 10 km area the major land use is

agricultural area, scattered intermittent with residential area and stone quarries.

Area details:

Components Area in sq. m.Total plot Area 8581.1Built up area 5084.84Parking area 333.6Green belt 2530.01



PLOT LAYOUT



4.3 Topography:

The project site is located in Pitampur Industrial Area, which is a developed Industrial area.

The existing natural toposgraphy has been disturbed and industrial area has been developed.

Slope has been maintained to channelize and drain the storm water.

4.4 Existing infrastructure

The existing manufacturing facility has two manufacturing plants, and other infrastructure

required for production. Some additional utilities and an additional will be constructed in the

new activity along with an ETP with MEE followed by ATFD and R.O plant.

4.5 Soil classification

The Pitampur area is covered by medium black soils. These soils are 0.46 to 0.9 meters thick

and are rich in lime and lime nodules. The sub-soil and the partially disintegrated rock below

allows easy drainage and hence these medium black soils can be freely irrigated.

4.6 Climatic data from secondary sources

The climate in proposed area is characterized by hot summer and general dryness throughout

the year except the south west monsoon season.

Climate Classification: Project site features an arid climate. In rainy season the climate is

very humid.

Temperature: Annual average max. Temperature is 40°C and min. temperature is 10 °C. The

highest temperatures are observed in the Month of May and the lowest are observed in the

Month of January.

Humidity: The humidity ranges between 14 to 90% throughout the year. The highest

humidity is found in monsoon followed by summer. The least humidity is observed in winter

season.

Rainfall: The average annual rainfall recorded is about 1000 mm. Majority of the rainfall is

received between July to September.

4.7 Social infrastructure available:

The supporting social infrastructure namely schools, hospitals, housing facilities etc are

available near the Pitampur Industrial Area.



Planning Brief

5.1 Planning concept:

The time schedule and planning of expansion will be determined after discussion with

architect and civil contractors.

The MP AKVN Indore have adequate road network and water will be provided by MP

AKVN Indore, however there is a bore well in the existing unit which will be used in

absence of supply from MP AKVN.

Electricity is provided by Madhya Pradesh Electricity Board. No additional power

transmission lines are required.

The construction material is available locally and it will be transported through road

network.

5.2 Population projection:

As per the 2011 census data, the Dhar district has total population of 2,185,793, out of which

1,112,725 are males and 1,073,068 are females. The literacy rate is 59% in the district.

The district has 47.03% worker population, out of which cultivators and agricultural workers

is a major source of labour type.

5.3 Land use planning:

The industry will be set up at existing site at Pitampur Industrial Area. The land is developed

as an Industrial Area and the land use will be industrial type. No cultivated land or forest land

will be utilized for the proposed unit.

5.4 Assessment of Infrastructure demand

The major physical infrastructure like road, water supply is provided by MP AKVN. The

electricity will be supplied by Madhya Pradesh Electricity Board by means of continuous

feeder substation.

The industrial infrastructure will be constructed after grant of EC. The need of social

infrastructure is not presently envisaged.

5.5 Amenities:

Basic amenities like road, electricity, process water are available at site. The drinking water

will be provided by further purification of process water by RO purification unit. In the plant

personal hygiene facilities will be provided to workers as per the rule.



6. Proposed infrastructure

6.1 Industrial area

The proposed infrastructure will be construction of an additional manufacturing plant with

supporting utilities along with ware house and ETP and MEE.

6.2 Green belt

Total 2530.01 sq. m. green belt area is provided in the plant. The green belt will be developed

by planting local trees which are resistant to pollutants.

6.3 Social infrastructure:

The supporting social infrastructure namely schools, hospitals, housing facilities etc are

available near the Pitampur Industrial Area.

6.4 Connectivity

The project is located in Pitampur Industrial area, Sector - III is easily connected to Mhow

Gatabillod road by internal roads provided by MPAKVN which is further connected to NH-3

(Mumbai – Agra Highway)

6.5 Sewerage system

The internal storm water drains are channelized through proper drains provided by MPAKVN.

6.6 Industrial waste management

The effluent generated from unit will be treated in a full fledged ETP with MEE followed by

ATFD with R.O plant to ensure recycle/ recovery of the entire treated effluent. The plant will

be operated as a ZLD unit.

6.7 Solid waste management

The hazardous waste is presently segregated as per category in schedule I of “Hazardous and

Other Wastes (Management and Transboundary Movement) Rules, 2016” and it is stored in

the demarcated area. The hazardous waste is disposed through CHWTSDF or it is sold to

authorized re-processing/ recycling vendors.



6.8 Power requirement/ supply/ source

For proposed activity, a transformer with a capacity of 1700 KVA is installed. The total power

requirement is 1150 KVA. The power will be supplied by Madhya Pradesh Electricity Board.

7. Rehabilitation and resettlement:

The unit will be established in notified industrial area of Pitampur. No rehabilitation and

resettlement will be envisaged.

8. Project schedule and cost estimation

It is proposed that the project will be commissioned after 12 months from grant of EC. The

cost estimation is presented in CA certificate attached as Annexure - 5.

9. Analysis of proposal :

Proposed production activity will provide employment to the local residents, resulting

financial and social benefits of the nearby people.

Indirect employment will be generated by the proposed unit like canteen, transportation

facilities to locals.

The export will result in generation of foreign exchange to the country.

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