ANNEXURE – 1
PROJECT LOCATION
Location Map of Project Site in GIDC, Panoli
GUJARAT
LONG VIEW
SHORT VIEW
ANNEXURE – 2
LAND AREA BIFURCATION
Sr.
No.
Area (m2)
Title
1.
Raw material storage area
185.00
2.
Finished product storage area
192.00
3.
Process area
298.00
4.
ETP area
30.00
5.
Boiler area
16.00
6.
D. G Set area
12.00
7.
Hazardous waste storage area
45.00
8.
Office
48.00
9.
Laboratory
24.00
10.
Green belt area
500.00
11.
Open space
150.00
TOTAL
1500.00
ANNEXURE – 4
LIST OF PRODUCT
Sr.
No.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
Name of Product
Choline Chloride Salt
Copper Sulphate
Ferrus Sulphate
Magnesium Sulphate
Zinc Sulphate
Potassium Chloride
Potassium Fluoride
Potassium Bromide
Sodium Bromide
Calcium Sulphate
Potassium Sulphate
Manganese Sulphate
Potassium Iodide
DI - Calcium Phosphate
TRI - Calcium Phosphate
P-Chloro Benzoic Acid
and/or
Allopurinol
and/or
Etodolac
and/or
Chloramphenicol
and/or
P-Hydroxy Benzaldehyde
and/or
Sulphadoxine
and/or
P-Amino Benzoic Acid
and/or
Ortho Cumidine
and/or
Nitro Amino Benzophenone
and/or
Nitro Chloro Benzoic Acid
and/or
Meta Amino Benzoic Acid
and/or
4 Methoxy Ethyl Phenol
and/or
Ariprazole
and/or
Quantity (MT/Month)
Existing
Proposed
Total After Expansion
40.0
20.0
200.0
800.0
20.0
------
40.0
20.0
200.0
800.0
20.0
125.0
--
125.0
35.0
25.0
--
--5.0
35.0
25.0
5.0
--
2.0
2.0
--
2.0
2.0
--
3.0
3.0
--
5.0
5.0
--
2.0
2.0
--
3.0
3.0
--
2.0
2.0
--
3.0
3.0
--
3.0
3.0
--
4.0
4.0
--
3.0
3.0
--
2.0
2.0
Sr.
No.
29.
30.
31.
32.
33.
34.
35.
36.
37.
38.
39.
40.
41.
42.
43.
44.
45.
46.
47.
48.
49.
50.
Name of Product
Doxazosin Mesylate
and/or
Alfuzosin HCl
and/or
Tamsulosin HCl
and/or
Tolterodine Tartrate
and/or
Clonidine HCl
and/or
Amlodipine Besylate
and/or
Bendroflumethiazole
and/or
Losartan Potassium
and/or
Hydrochlorothiazide
and/or
Benazapril HCl
and/or
Telmisartan
and/or
Valsartan
and/or
Lacidipine HCl
and/or
Olmesartan Medoxomil
and/or
Lamotregence
and/or
Levetiracetam
and/or
Tiagabine HCl
and/or
Memantine HCl
and/or
Donepezil HCl
and/or
Phenylepherine HCl
and/or
Buprenorphine HCl
and/or
Meloxicam
and/or
Quantity (MT/Month)
Existing
Proposed
Total After Expansion
--
1.0
1.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
3.0
3.0
--
3.0
3.0
--
2.0
2.0
--
1.5
1.5
--
1.5
1.5
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
Sr.
No.
51.
52.
53.
54.
55.
56.
57.
58.
59.
60.
61.
62.
63.
64.
65.
66.
67.
68.
69.
70.
Name of Product
Larnoxicam
and/or
Pregabalin
and/or
Gabapentin
and/or
Celecoxib
and/or
Pioglitazone HCl
and/or
Cetirizine HCl
and/or
Fexofenadine HCl
and/or
Aldendronate sodium
and/or
Tris Nitro
and/or
Tris Amino
and/or
Butaphosphan
and/or
Sucralfate
and/or
Doxazosin
and/or
Alfuzosin HCl
and/or
Darifenacin
and/or
Amlodipine
and/or
Bendroflumethiazide
and/or
Dinitolmide
and/or
Roxarsone
and/or
Bis(2-Chloroethyl) Amine HCl
Quantity (MT/Month)
Existing
Proposed
Total After Expansion
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
50.0
50.0
--
5.0
5.0
--
3.0
3.0
--
50.0
50.0
--
3.0
3.0
--
2.0
2.0
--
2.0
2.0
--
3.0
3.0
--
2.0
2.0
--
5.0
5.0
--
5.0
5.0
--
15.0
15.0
NOTE: For proposed new products, total production capacity shall not exceed
200 MT/Month.
ANNEXURE – 5
MANUFACTURING PROCESS
(1)
P-CHLORO BENZOIC ACID
Process Description:
Meta bromo phenol react with dimethyl sulphate in presence of caustic lye gives meta bromo anisole
crude. Crude further distil to get pure meta bromo anisole.
Reactions Involved: OXIDATION
Chemical Reaction:
COOH
CH3
Pressure high
+
4HNO 3
+
high temperature
Cl
M WT : 126.5
4NO 2
M WT: 4X 46=186
P-CHLORO BENZOIC ACID
C7H5ClO 2
MWT: 156.5
C7H7Cl
+
2H 2O
+O 2
+
2H2O
NITROUS OXIDE
4X 63 =252
Cl
P - CHLORO TOLUENE
4NO 2
4HNO 3
M WT: 36
(2)
ALLOPURINOL
Process Description:
When 3-Amino-pyrazole-4-carboxamide sulphate, formamide and formic acid together heated in
Allopurinol product is produced.
Chemical Reaction:
O
O
H2SO4
OH
H2N
H2N
N
H2N
H2N
N
H
N
N
H
HCONH2
HCOOH
N
N
N
N
H
MW= 350
MW= 272
3-amino pyrazole-4-carboxamide sulphate
Flow Chart:
3-Aminopyrazole-4-carboxamide sulphate
Formamide
Formic Acid
Final product
2
(3)
ETODOLAC
Process Description:
Product is obtained in two stages.
Stage-1: 7-Ethyl Tryptophol and Methyl 3-oxopentanoate undergo condensation in sulphuric acid and
Methanol media. Reaction takes place as below.
Stage-2: Product is obtained on treating Etodolac Methyl ester with Sodium hydroxide and on
precipitation with Hydrochloric acid .Methanol is the solvent used in the process. Product is purified
with water.
Chemical Reaction:
Stage 1:
O
O
Sulphuric acid
+
Methanol
O O
H
N
+
H2O
O
HO
N
7-Ethyl Tryptophol
C12H15NO
Mol. Wt.: 189.25
O
(1,8-Diethyl-1,3,4,9-tetrahydropyrano[3,4-b] indol-1-yl)acetic acid methyl ester
Methyl 3-oxopentanoate
C18H23NO3
Mol. Wt.: 301.38
C6H10O3
Mol. Wt.: 130.14
Water
Mol. Wt.: 18
Stage 2:
MeOH
Etodalac Methyl ester
M.Wt: 301
Sodium
Hydrochloric
Hydroxide
acid
M.Wt: 36.5
M.Wt: 40
Etodolac
Sodium
Chloride
Methanol
M.Wt: 287
M.Wt: 58.5
M.Wt: 32
Flow Chart:
Stage-1
7-Ethyl Tryptophol
Methyl 3-oxopentanoate
Sulphuric acid
Methanol
Water
Reactor
Centrifuge
Methanol to recovery
Dilute Sulphuric acid
Stage-1 Product
Stage-2
Etodalac Methyl ester
SodiumHydroxide
Hydrochloric acid
Methanol
Water
Reactor
Centrifuge
Finished Product
Methanol to recovery
Inorganic salt solution
(4)
CHLORAMPHENICOL
Process Description:
When (1R, 2R)-2-Amino-1-(4-nitrophenyl) propane-1, 3-diol and Methyl dichloro acetate reacts
together in Methanol solvent medium, Chloramphenicol product is produced.
Chemical Reaction:
OH OH
Cl
HO
-
O
NH2
N+
O
+
O
OH
Cl
MeOH
O
Cl
HN
O2N
(1R,2R)-2-Amino1-(4-nitrophenyl)propane-1,3-diol
C9H12N2O4
Mol. Wt.: 212
+
CH3OH
Cl
O
Methyl dichloro acetate
Chloramphenicol
C3H4Cl2O2
Mol. Wt.: 143
C11H12Cl2N2O5
Mol. Wt.: 323.1
Methanol
Mol. Wt.: 32
Flow Chart:
(1R,2R)-2-Amino1-(4-nitrophenyl)propane-1,3-diol
Methyl dichloro acetate
Methanol
Methanol to recovery
Final product
(5)
P-HYDROXY BENZALDEHYDE
Process Description:
P-Cresol oxydised with oxygen in alkaline condition at morderate temperatere followed by
acidification gives p-hydroxy benzaldehyde.
Reaction Involved: OXIDATION
Chemical Reaction:
O
CH3
+
H
O2
+
32
M WT : 18
OH
P - CRESOL
C7H8O
M WT : 108
(6)
H2O
OH
P -HYDROXY BENZALDEHYDE
C7H6O 2
M WT : 122
SULPHADOXINE
Process Description:
Sulphadoxine is obtained in three stages and produced as below;
Stage-1: Sulfanilamide is reacted with Sodium hydroxide in methanol and treated with water
to get Stage 1.
Stage-2: Stage 1 compound coupled with 4,6 dichloro 5 methoxy pyrimidine in DMF, Acetic
Acid to get Stage 2.
Stage-3: Stage 2 material was treated with MeOH and Sodium Hydroxide followed by treated
with Acetic acid, Calcium hydroxide to get Sulphadoxine.
Chemical Reaction:
O
H2N S O
Na
O
H2N S O
20% aq NaOH
H2O,MeOH
, RT, 1hr
NH2
NH2
Sulfanilamide
Sulfanilamide sodium salt (Or)
Sodium Sulfanilamide
Molecular Formula: C6H8N2O2S
Formula Weight:
172.20492
Na O
H2N S O
Molecular Formula: C6H8N2NaO2S
Formula Weight:
195.194689
N
O
+
NH2
Sulfanilamide sodium salt
Cl
Cl
N
N
DMF,90-95
o
C, 2hr
H2O,Aceticacid
4,6-dichloro-5methoxypyrimidine
Molecular Formula: C6H8N2NaO2S Molecular Formula: C5H4Cl2N2O
Formula Weight:
195.194689
Formula Weight:
179.00406
H2N
N
O
S NH
O
Cl
O
4-amino-N-(6-chloro-5-methoxy
pyrimidin-4-yl)benzenesulfonamide
Molecular Formula: C11H11ClN4O3S
Formula Weight:
314.74804
N
N
N
H2N
O
S NH
O
1. MeOH,NaOH,
60-65oC, 5-6hrs
Cl
H2N
O
2. H2O,Acetic acid
Ca(OH)2, 60-65oC, 1hr
N
O
S NH
O
O
O
4-amino-N-(5,6-dimethoxypyrimidin
-4-yl)benzenesulfonamide (OR)
Sulfadoxine, CAS 2447-57-6
4-amino-N-(6-chloro-5-methoxy
pyrimidin-4-yl)benzenesulfonamide
Molecular Formula: C11H11ClN4O3S
Formula Weight:
314.74804
Molecular Formula: C12H14N4O4S
Formula Weight:
310.32896
Flow Chart:
Stage 1
Sulfanilamide
20% aq NaOH H2O,MeOH,
RT, 1hr
Sulfanilamide sodium salt
Stage 2
Sulfanilamide sodium salt
4,6-dichloro-5methoxypyrimidine
DMF,
H2O,AcOH,
90-95oC, 2hr
4-amino-N-(6-chloro-5-methoxy
pyrimidin-4-yl)benzenesulfonamide
Stage-3
4-amino-N-(6-chloro-5-methoxy
pyrimidin-4-yl)benzenesulfonamide
1. MeOH,NaOH,
60-65oC, 5-6hrs
2. H2O,Acetic
acid, Carbon
Ca(OH)2,
60-65oC
4-amino-N-(5,6-dimethoxypyrimidin
-4-yl)benzenesulfonamide
(7)
P- AMINO BENZOIC ACID
Process Description:
P- nitro benzoic acid hydrogenation in presence of methanol by catalytic reduction at
moderate temperature and pressure. Isolate the material as crude after distilled off methanol
and removal of Raney nickel catalyst. Crude purified in water at higher temperature.
Reaction Involved: HYDROGINATION
Chemical Reaction:
COOH
COOH
+
3H2
RANEY NICKEL
NO 2
2H2O
M WT : 36
NH2
P - NITRO BENZOIC ACID
P -AMINO BENZOIC ACID
C7H7NO 2
C7H5NO4
M WT : 137
M WT : 167
(8)
+
ORTHO CUMIDINE
Process Description:
Ortho nitro cumene hydrogenated with raney nickel catalyst in presence methanol solvent
gives ortho cumidine crude which is further purified by distillation.
Reaction Involved: REDUCTION BY HYDROGENATION
Chemical Reaction:
H3C
CH3
H3C
NO 2
+
ORTHO NITRO CUMENE
C9H11NO 2
M WT: 165
3H2
RANEY NICKEL
HYDROGEN GAS
M WT : 3X 2 =6
CH3
NH2
+
ORTHO CUMIDINE
C9H13N
M WT: 135
2H2O
2X 18 =36
(9) NITRO AMINO BENZOPHENONE
Process Description:
Nitro chloro benzophenone reacts with ammonia at higher temperature and pressure gives
nitro amino benzophenone.
Reactions Involved: AMMONOLYSIS
Chemical Reaction:
O
O
NO 2
+
NO 2
2NH3
+
34
NH4Cl
NH2
Cl
NITRO CHLORO BENZOPHENONE
C13H8ClNO 3
M Wt: 261.50
NITRO AMINO BENZOPHENONE
C13H10N2O 3
M Wt: 242
AMMONIUM CHLORIDE
M Wt: 53.5
(10) NITRO CHLORO BENZOIC ACID
Process Description:
Nitration of p-chloro benzoic acid with 70% w/w in water as solvent at 30-32°c gives Nitro
Chloro Benzoic Acid.
Reaction Involved: NITRATION
Chemical Reaction:
COOH
COOH
+
+
HNO 3
M WT : 63
Cl
P -CHLORO BENZOIC ACID
C7H5ClO 2
M WT : 156.5
NO 2
Cl
NITRO CHLORO BENZOIC ACID
C7H4ClNO 4
M WT : 201.5
H2O
M WT : 18
(11)
META AMINO BENZOIC ACID
Process Description:
Meta nitro benzoic acid hydrogenation in presence of methanol by catalytic reduction at
moderate temperature and pressure. Isolate the material as crude after distilled off methanol
and removal of Raney nickel catalyst. Crude purified in water at higher temperature.
Reactions Involved: HYDROGINATION
Chemical Reaction:
COOH
COOH
+
3H2
RANEY NICKEL
+
NO 2
NH2
META NITRO BENZOIC ACID
C7H5NO 4
M WT : 167
(12)
2H2O
META AMINO BENZOIC ACID
C7H7NO 2
M WT : 137
M WT : 36
4-METHOXY ETHYL PHENOL
4-hydroxy acetophenone brominates at lower temperature in presence of acetic acid gives
bromo intermediate after distilled off acetic acid. bromo intermediate further methoxylated with
methanol and sodium hydroxide at higher temperature. isolate the methoxylated intermediate
after removing the inorganic salt and distilled off the methanol. Residue further hydrogenation
in presence of acetic acid a solvent gives 4-methoxy ethyl phenol crude which is further
purified by high vacuum distillation.
REACIONS INVOLVED: Bromination, Methoxylation and Hydrogenation
Chemical Reaction:
OH
OH
+
Br2
BROMINE
MW:159.8
+
HBr
MW:79.8
COCH2Br
4 HYDROXY BROMO ACETOPHENONE)
C8H7BrO 2, MWT:202.9
COCH3
4 -HAP (C8H8O 2 MW:124)
OH
NaOH + METHANOL
+
OH
NaBr
H2 Pd/C
COCH2OCH3
ACETIC ACID
4 - HYDROXY METHOXY ACETOPHENONE
C9H10O 3
MWT:166
CH2CH2OCH3
-
4 METHOXY ETHYL PHENOL
C9H12O 2
MWT: 152
(13) ARIPIPRAZOLE
Process Description:
A suspension of DCP (1-(2,3-dichlorophenyl)piperazine) Hydrochloride and DBB (1-4Dibromobutane) is made in water and then allowed to react at refluxing temperature in
presence of excess Potassium carbonate. The crude intermediate obtained at this stage by
partial condensation of DCP and DBB is separated out and then solidified by addition of
acetone.
The pure intermediate I and 7-Hydroxy Carbostyryl are suspended in xylem and excess
potassium carbonate is charged. The resulting heterogeneous mixture is refluxed to complete
the reaction. The crude product is isolated by distillation under vacuum followed by addition of
water to dissolve away potassium salts.
The solid product obtained at this stage is used as
such in the next step.
The crude product is dissolved in toluene and carbon is added. Refluxing, filtration, cooling,
filtration and drying provides solid pure product.
Chemical Reaction:
(14)
DOXAZOSIN MESYLATE
Process Description:
Stage-1: Ethyl Acrylate reacts with Bromine in presence of Chloroform as solvent medium to form Stage-1
product.
Stage-2: Stage-1 reacts with Pyrocatechol, Piperazine & Potassium Carbonate in presence of Hydrochloric
acid and Ammonia with Acetone, Toluene and Chloroform as solvent media to give 1-[(2,3-Dihydro-1,4Benzodiaoxan-2-2Yl) Carbonyl]Piperazine compound.
Stage-3:
1-[(2,3-Dihydro-1,4-Benzodiaoxan-2-2Yl) Carbonyl]Piperazine
is condensed with 4-Amino-2-
Chloro-6,7-Dimethoxy Quinazoline and Potassium Carbonate in presence of n-Butanol and Acetone as
solvent media to give Doxazosin base.
Stage-4: Doxazosin base is salt formation with Methane Sulfonic Acid in presence of Chloroform, Methanol
and Acetone solvent media to get Doxazosin Mesylate.
Chemical Reaction:
(15) ALFUZOSIN HYDROCHLORIDE
Process Description:
Stage-I: 4-Amino-2-chloro-6,7-dimethoxy quinazoline on reaction with 3-(N-Methyl amino) Propionitrile
in presence of Triethylamine and further reacts with Tetrahydro-2-furoic acid in presences of Ethyl
Chloroformate and Sodium Hydroxide in Methylene Dichloride and Methanol solvent media to form
Alfuzosin (Crude).
Stage-II: Alfuzosin (Crude) on purification in presence of Methanol solvent medium to get pure form of
Alfuzosin.
Stage-III: Alfuzosin (Pure) on reaction with Hydrogen Chloride in Ethanol in presence of Isopropyl
Ether and Ethanol solvent media and is purified with Carbon to yield Alfuzosin Hydrochloride.
Chemical Reaction:
(16)
TAMSULOSIN HCL
Process Description:
Stage-1: (S)-5-(2-Aminopropyl)-2-methoxybenzenesulfonamide is reacted with 2-(O Ethoxyphenoxy)
ethyl bromide in presence of 50% sodium hydroxide solution and further Hydrochloride salt formation
with Ethanolic HCl gives Tamsulosin HCl.
Stage-2: Product is purified using Methanol and Ethanol.
Chemical Reaction:
(17)
TOLTERODINE TARTRATE
Process Description:
Cyclization of P-Cresol with cinnamic acid and sulphuric acid formed TT-I. Reduction of TT-I with
sodium borohydride in IPA solvent is then to get TT-II. TT-II is insitu stage in which Dimethyl Sulfate is
used for methylation and further PTSCl (P-toluene sulphonyl chloride) react and gives TT-III.
Further reaction of TT-III with N,N-disopropyl amine gives amino compound. This amino compound is
hydrolysed with HBr and water gives TT-IV. TT-IV is then broked by using ammonia to form Tolterodine
base, then there is salt formation with L- tartaric acid gives Tolterodine tartrate.
Chemical Reaction:
(18) CLONIDINE HCL
Process Description:
2,4–Disulphonamide–5-choloroaniline is reacted with Formaldehyde. After completion of the reaction,
the reaction mixture is centrifuged and dried to get ClonidineHCl.
Chemical Reaction:
2,4–Disulphonamide–5-choloroaniline + Formaldehyde
Clonidine HCl
.HCL
(19)
AMLODIPINE BESYLATE
Process Description:
This stage involve, Benzylidine intermediate preparation by condensation of ethyl 4-[2-(1, 3-dioxo1, 3dihydro-2H-isoindol-2-yl) ethoxy]-3-oxobutanoate with 2-chloro benzaldehyde in presence of piperidine
& acetic acid as a catalyst. Benzylidine intermediate further reacted with methyl(2E)-3aminobut-2enoate in acetic acid to form Phthaloyl Amlodipine.
It involves preparation of free base of Amlodipine from Methylamine solution with DNS (Denatured with
Toluene) as a solvent.
Free Amlodipine is reacted with Benzene sulfonic acid with DNS to form crude Amlodipine besylate.
Purification of Amlodipine Besylate crude with DNS as a Solvent is done to get Amlodipine Besylate.
Chemical Reaction:
(20) LOSARTAN POTASSIUM
Process Description:
Stage – I: Cyano biphenyl compound allylic bromination to get Stage –I compound.
Stage-II:
Stage –I and immidazole compound in presence of base condensed to get Stage –II
compound.
Stage-III: Stage –II compound reduction with sodium borohydride to get Alcohol compound.
Stage-IV: Stage –III reacts with sodium azide to get Tetrazole compound.
Stage-V: Stage –IV reacts with potassium hydroxide in presence of methanol solvent to get Losartan
Potassium salt.
Chemical Reaction:
(21) HYDROCHLOROTHIAZIDE
Process Description:
2,4–Disulphonamide–5-choloroaniline is reactedwith Formaldehyde. After completion of the
reaction, the reaction mixture is centrifuged anddried to get Hydrochlorothiazide.
Chemical Reaction:
(22)
BENAZAPRIL HCl
Process Description:
Stage I: Benzene derivative and Methyl ester derivative condensed in presence of sulphuric acid to get
Benazapril base.
Stage II: Benazapril base was purified and converted in to its HCl salt using Isopropyl alcohol as
solvent.
Chemical Reaction:
(23) TELMISARTAN
Process Description:
Bibenzimidazole&bromomethyl ester is condensed in presence of sodium methoxide in DMFto give
Telmi-I (Methyl 4’-[[4-Methyl-6-(1-methyl-1H benzimidazol-2-yl)-2-propyl-1H-benzimidazole1-yl] methyl]
biphenyl-2-carboxylate).
Telmi-I is hydrolyzed using potassium hydroxide in methanol & water mixture to give Telmisartan.
Chemical Reaction:
(24)
VALSARTAN
Process Description:
Stage-I: Esterification of Vilene in presence of Thionyl chloride to get methyl ester of Valene.
Stage-II: Condensation of Valene methyl ester and Bromoderivative in presence of base to get
cynobiphenyl methyl ester.
Stage-III: Condensation of cynobiphenyl methyl ester and pentanyl chloride in presence of base to get
N-Substutedcynobiphenyl methyl ester.
Stage-IV: N-Substutedcynobiphenyl methyl ester reaction with Tributyl tin chloride & Sodium azide to
get Valsartan.
Chemical Reaction:
(25)
LACIDIPINE HYDROCHLORIDE
Process Description:
Biphenyl compound on electrophilic substitution with succinic anhydride in presence of aluminum
chloride and Dichloro methane will give Stage-1 which on further condensation with Chloro compound
and methoxy derivative in Toluene will give Lacidipine Hydrochloride on further purification in Methanol
will give Lacidipine Hydrochloride pure.
Chemical Reaction:
(26)
OLMESARTAN MEDOXOMIL
Process Description:
Hydrolysis of OLMT-I i.e;[Ethyl-4-(1-Hydroxy-1-methylethyl)-2-propyl-1-{4-[2-(trityltetrazole-5yl)phenyl}
methylimidazole-5-carboxylate] with sodium hydroxide in Isopropyl alcohol as solvent resulting into
OLMT-II.
OLMT-II is then reacted with chlorodioxolene (known as 4-chloromethyl-5-methyl-1,3-dioxol-2one) in
presence of potassium carbonate and DMF as solvent to get crude OLMT-III this is then crystallized
with acetonitrile and resulted into OLMT-III.
OLMT-III is deprotected with aqueous acetic acid & removed trityl alcohol from reaction mass after
complete reaction by filtration. Filtrate is then evaporated by ATFD and residual API crystallized with
acetone to get final OlmesartanMedoxomil, which is chemically known as 4-(1hydroxy-1-methylethyl)2-propyl-1-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-1H-imidazole5-carboxylicacid(5-methoxy- 2
-oxo-1,3-dioxol-4-yl) methylester.
Chemical Equation:
(27)
LAMOTREGENE
Process Description:
Stage-1: Water is charged into the reactor followed by amino guanidine bi-carbonate, thencooled.
Sulphuric acid is slowly charged into the reactor and the clear dissolution ischecked. 2, 3 Dichloro
Benzoyl Cyanide solutions are added into the reactor. And maintained for 30-45 min then cooled. The
sample is checked for completion ofreaction and maintained for 20 hours then cooled and maintained
for 1 hour. Thereaction mass is filtered and washed with UF water and collected stage-1 crudematerial.
Methanol is charged into the reactor followed by wet material and CausticSoda Flakes. Mass is stirred
for 10-15 minutes, and heated to reflux then maintainedunder reflux for 2 hours. The reaction mass is
cooled and the sample is checked forcompletion of condensation product. The solvent is distilled off
completely undervacuum UF water is charged into the reactor and heated then stirred at
sametemperature for 15 to 30 minutes. The reaction mass is cooled and maintained at
sametemperature for 1 hour. The mass is filtered and washed with UF water and collectedStage -1 wet
material.
Stage-2: Methanol is used as a solvent in this stage. Initially Methanol is charged into the reactor
followed by stage-1 wet material. The reaction mass is heated to reflux and maintained under reflux for
30-45 min then dissolution is checked. The reaction mass is transferred through Leaf Filter and
Cartridge filters and the filtrate is collected into the reactor by applying the Nitrogen and sample is
checked for particle free. Distilled off the solvent up to 70 % of the total volume under vacuum. Then
cooled and maintained at same temperature for 1 hour. The mass is centrifuged and washed with
Methanol and collected stage-2 technical grade wet material i.e. 6-(2, 3Dichlorophenyl)-1, 2, 4-triazine3, 5- diamine and dried.
Chemical Reaction:
(28)
LEVETIRACETAM
Process Description:
SABAM Hydrohcloride & 4-Chlorobutanoyl chloride (4-CBC) is condensed in presence of tetrabutyl
ammonium bromide and sodium sulfate in MDC to form condensed product which is further cyclised
using potassium hydroxide to give Leve-I. Leve-I is purified in ethylacetate to get Levetiracetam.
Chemical Reaction:
(29) TIAGABINE HYDROCHLORIDE
Process Description:
Tiagabine base dissolve in Isopropyl alcohol and treat with charcoal and add con. Hydrochloric Acid.
Isolate Tiagabine Hydrochloride at lower temperatute. Dry unsre vacuum get the pure Tiagabine
Hydrochloride.
Chemical Reaction:
OH
O
S
N
OH
H3C
H3C
S
+
HCl
S
IPA
O
N
H3C
TIAGABINE BASE
C20H22NO 2S2
M Wt : 375
H3C
S
. HCl
M Wt : 36.5
TIAGABINE HYDROCHLORIDE
C20H22NO 2S2 .HCl
M. Wt : 411.5
(30) MEMANTINE HCl
Process Description:
Bromination of 1,3-Dimethyladamantane gives bromo MMT.Bromo MMT is reacted with acetonitrile &
sulphuric acid and Acetamido MMT is formed.Acetamido MMT is hydrolysed in presence of caustic
gives memantine freebase.Memantine hydrochloride is then prepared in THF solvent by using Aq.HCl
and memantine freebase.
Chemical Reaction:
(31)
DONEPEZIL HYDROCHLORIDE
Process Description:
Stage-I:
1-Benzyl-4-(5,6-dimethoxy-1-indanon)-2-yldienyl
methyl
piperidine
Hydrochloride
was
suspended in Methanol. The reaction mixture was heated at 55-60°C. After complete dissolution of
enone hydrochloride, cooled to 3-8°C. The reaction mass subjected to hydrogenation using 5% pd/c
(50% wet) at 3-8°C for 5 hrs. After completion of reaction, filtered the reaction mass and concentrated
to get residue. This solid was subjected acid base purification then cooled the reaction mass to 5-10°C
and stir it for 6 hrs. Filtered and washed with chilled water to get Donepezil hydrochloride crude.
Stage-II: Donepezil hydrochloride was dissolved in Methanol at 50-60°C and treated with activate
charcoal. The reaction mass was filtered and concentrated to minimum. Then cooled the reaction mass
to 25-35°C and charged MTBE and seeded with Donepezil HCl. The reaction mass was further cooled
to 5-10°C and stirred it for 2 hrs. Filtered the product and washed with chilled Methanol:
MTBE
mixture. The material was dried at 50-55°C under vacuum for 2 hrs to get Donepezil hydrochloride. If
material falling in specification reprocess the material.
Chemical Reaction:
(32)
PHENYLEPHRINE HYDROCHLORIDE
Process Description:
Stage-1:3-HydroxyAcetophenone reacts with Bromine in the presence of Aluminum chloride and Ethyl
Acetate to get Stage-1 Compound
Stage-2: Stage-1 comp. reacts with N-Methyl Benzyl Amine in the presence of IPA-HCl to get Stage-2
Stage-3: Stage-2 reacts with 10% Palladium carbon in the presence of Hydrogen gas and Methanol as
a solvent media to get Stage-3
Stage-4: Stage-3 reacts with L(+) Tartaric Acid in the presence of Isopropyl alcohol and Liq.Ammonia
to get Stage-4
Stage-5: Stage-4 Compound reacts with Liq.Ammonia and Sulfuric Acid in the presence of Acetic
Anhydride to get Stage-5
Stage-6: Stage-5 Compound reacts with Hydrochloride in the presence of Isopropyl Alcohol to get
Phenylephrine Hydrochloride
Chemical Reaction:
(33)
BUPRENORPHHINE HYDROCHLORIDE
Process Description:
Buprenorphhine base dissolve in Isopropyl alcohol and treat with charcoal and add con. Hydrochloric
Acid. Isolate Buprenorphhine Hydrochloride at lower temperature. Dry under vacuum get the pure
Buprenorphhine Hydrochloride.
Chemical Reaction:
HO
HO
O
O
N
H3C
+
CON. HCl
IPA
N .HCl
H3C
O
H3C
O
H3C
CH3
CH3
H3C
H3C
H3C
H3C
CH3
CH3
CH3
CH3
BUPRENORPHINE HYDROCHLORIDE
BUPRENORPHINE BASE
C29H41NO 4
M. Wt : 467
C29H41NO 4 .HCl
(34) MELOXICAM
Process Description:
Condensation of hydroxyl methyl benzothiazine butane dione with 5-methyl-1,3-thiazole-2-amine
in
presence of strong base gives meloxicam which in methasnol and isolate meloxicam at lower temp.
Dry under vaccum to get the pure meloxicam.
Chemical Reaction:
OH
O
CH3
S
+
H3CH2COC
N
N
NH2
5-methyl-1,3-thiazol-2-amine
C4H6N2S
M Wt : 114.16
H3C
S
O
O
1-(4-hydroxy-2-methyl-1,1-dioxido-3,8a-dihydro-2H-1,2-benzothiazin
-3-yl)butane-1,2-dione
NaOH (40)
C13H15NO 5S
M Wt : 281.24
O
N
H3C
S
OH
NH
+ CH3CH2ONa + H2O
N
H3C
S
O
C14H13N3O 4S2
M Wt : 351.40
O
M Wt : 66
M Wt : 18
(35)
LARNOXICAM
Process Description:
The condensation of Pyridin-2-ylcarbamic chloride with 6-chloro-2-methyl-2H-thieno [2,3-e{1,2}thiazin4-ol1,1-dioxide in presence of sodium methoxide gives Larnoxicam crude which is further purified in
methanol gives pure Larnoxicam.
Chemical Reaction:
OH
N
S
COCl
NH
+
+
Cl
N
H3C
S
O
O
6-chloro-2-methyl-2H-thieno[2,3-e][1,2]thiazin4-ol 1,1-dioxide
C7H6ClNO 3S2
M Wt : 251.5
pyridin-2-ylcarbamic chloride
C6H5ClN2O
M Wt : 156.50
N
CH3ONa
Sodium methoxide
M Wt : 54
OH
O
+ NaCl
S
+ CH3OH
NH
Cl
N
H3C
S
O
O
Larnaxicam
C13H10ClN3O 4S2
M Wt : 371.51
(36)
Sodium Chloride
Methanol
M Wt : 58.5
M Wt : 32
PREGABALIN
Process Description:
CMH ((+)-3-(carbamoylmethyl)-5-methyl hexanoic acid) is treated with R-(+)-1 Methyl benzyl amine in
chloroform & methanol mixture to obtain R-CMH Salt [R(+)-1-Methylbenzyl amine
salt of R (-)-3
(Carbamoylmethyl)-5-methyl hexanoic acid] (step-1) as solid whereas the unwanted salt of (S)-isomer
remains in the solution (filtrate-also contains some R(+)-1-Methylbenzyl amine
salt of R (-)-3
(Carbamoylmethyl)-5-methyl hexanoic acid).
R (+)-1-Methylbenzyl amine salt of R (-)-3 (Carbamoylmethyl)-5-methyl hexanoic acid is acidified with
aqueous sulfuric acid in water to obtain R (-)-3 (Carbamoylmethyl)-5-methyl hexanoic acid) step-2 (RCMH) as precipitate, which can be dried under vacuum or it can be directly processed as wet mass in
to the next stage( Hofmann rearrangement).The R (+)-1-Methylbenzylamine goes in filtrate as sulphate
salt.
R (-)-3-(Carbamoylmethyl)-5-methyl hexanoic acid (R-CMH) is reacting with NaOCl solution to undergo
Hoffmann reaction and optical inversion to give wet Crude Pregabalin which can be directly purified as
wet mass or it can be dried under vacuum.
Crude Pregabalin (Step-3 mass) is purified using aqueous isopropanol to afford Pregabalin.
Chemical Reaction:
(37)
GABAPENTIN
Process Description:
1,1-cyclohexane
diacetic
acid
anhydride
(CDAN)
istreated
with
NH3/IPA
to
yield
1,1-
cyclohexanediacetic acid monoamide, whichis converted into Gabepentine by treated with Sodium
Hypobromitesolution.
Chemical Reaction:
(38)
CELECOXIB
Process Description:
Cele-1 is prepared from 4-Methyl acetophenone and ethyltrifluoroacetate in toluene using sodium
methoxide as a base. To slurry of sodium methoxide in toluene 4- Methyl acetophenone is added
slowly and stirred. Then ethyltrifluroacetate is added slowly. Reaction mass is heated and stirred to
complete the reaction. After completion of reaction, reaction is cooled and quenched with water. pH is
made acidic by adding conc. HCl and product is extracted in toluene. Toluene layer is concentrated to
give oil, which is taken in isopropanol, and water is added to obtain Cele – 1 in solid form. Cele-1 is
filtered washed with water and dried.
Cele-1 and 4-Hydrazino benzene sulfonamide HCl are taken in ethanol and refluxed. After completion
of reaction, reaction mass is cooled and filtered to remove excess unreacted 4Hydrazino benzene
sulfonamide. Water is added to ethanol filtrate to precipitate the product. Product is filtered and dried to
get Celecoxib Crude.
Celecoxib pure is obtained from Celecoxib crude by crystallization in toluene. Celecoxib crude is
dissolved in toluene and charcolized with activated carbon. Then reaction mass is cooled and ethanol
is added to it. Reaction mass is filtered through celite bed followed by filtration. Filtrate is heated to
distill out ethanol. The reaction mass is cooled and stirred. Product is filtered and wet solid is again
crystallized with toluene to give pure Celecoxib.
Chemical Reaction:
(39)
PIOGLITAZONE HYDROCHLORIDE
Process Description:
5-Ethyl-2-(2-(4- Nitro phenoxy)ethyl)pyridine (EPNB) is hydrogenated in presence of palladium catalyst
to produce PGL-I, which is further diazotized using sodium nitrite solution in water to get diazotized
PGL-I. It is further reacted with hydrogen bromide and methyl acrylate in presence of copper oxide (I)
to get PGL-II.
PGL-II is cyclized using thiourea and sodium acetate in methanol to give PGL-III (5-({4-[2-(5ethylpyridin-2-yl) ethoxy]benzyl}-2-imino-1,3-thiazolidin-4-one).
PGL-III is reacted with hydrochloric acid in water to give PGL-IV ((5-({4-[2-(5-ethylpyridin-2yl)ethoxy]benzyl}-1,3-thiazolidin-2,4-dione).
PGL-IV is purified in DMF and water mixture to get PGL-V (pure Pioglitazone). PGL-V is isolated as a
hydrochloride salt using concentrated Hydrochloride acid in ethanol water mixture as a solvent to get
Pioglitazone hydrochloride.
Chemical Reaction:
(40)
CETIRIZINE HCl
Process Description:
Stage 1: Piperazine derivative and 2-chloroethanol is charged to the reactor and with the influence of
Triethylamine stage 1 reaction is taken place and Stage 1 product is formed hydroxy compound and
Triethylamine hydrochloride.
Stage 2: Hydroxy compound (stage 1) product is charged into the reactor along with Chloroacetamide
and Sodium hydride and as the reaction continuous stage 2 product is formed.
Stage 3: Amide (stage 2) product is charged to the reactor and with the influence of Sodium hydroxide
and HCl reaction is taken place and stage 3 products is formed.
Stage 4: Cetirizene Base is charged to the reactor along with HCl reacts to form Cetirizene
Dihydrochloride crude.
Stage 5: CetirizeneDihydrochloride crude is washed with water along with acetone to form Cetirizene
Dihydrochloride pure.
Chemical Reaction:
(41) FEXOFENADINE HYDROCHLORIDE
Process Description:
Esterification of 2-[4-(4-Chlorobutanoyl)phenyl]-2-methylpropanoic acid with MethanolicHCl to produce
Methyl 2-[4-(4-Chlorobutyryl) phenyl-2-methylpropanoate (FEXO-1). N-Alkylation reaction of Azacyclonol
and FEXO-1 in presence of Potassium bicarbonate and Potassium iodide in Methyl-iso-butyl ketone (MIBK)
& water under heating condition. After reaction completion separate organic and aqueous layer followed by
distillation of Methyl-iso-butyl ketone, FEXO-2 isolated as solid material using denatured spirit and water.
KETO ESTER (FEXO-2) is treated with Sodium borohydride in Methanol & then hydrolysis using sodium
hydroxide to obtain crude FEXO BASE (FEXO-3). The crude FEXO BASE (FEXO-3) is purified twice, using
methanol and acetone mixture to get pure FEXO BASE (FEXO-4). FEXO-4 is treated with aqueous
Hydrochloric acid in iso-propanol & then ethyl acetate added to isolate Crude FEXOFENADINE
HYDROCHLORIDE (FEXO-5). Fexofenadine hydrochloride (FEXO-5) is purified using a solvent mixture of
methanol, iso-propanol and ethyl acetate to yield pure FEXOFENADINE HYDROCHLORIDE (FEXO-6).
Chemical Equation:
(42) ALENDRONATE SODIUM
Process Description:
In the present process Pyrrolidone is hydrolyses with water, methane sulphonic acid and phosphorous
trichloride to γ-amino butyric acid (GABA) which is further reacted with phosphorous trichloride in the
presence of methane sulphonic acid. Reaction mass is quenched and hydrolyzed, sodium Alendronate
is isolated at pH 4.3 with 50% aqueous sodium hydroxide.
Chemical Reaction:
(44) TRIS NITRO
Process Description:
Nitro methane react with formaldehyde 39% solution in presence of sodium carbonate gives Tris Nitro
crude which is further purified in Amyl alcohol.
Chemical Reaction:
Tris Nitro reaction scheme.
OH
CH3NO 2
Nitromethane
M. Wt: 61
+
3HCHO
Formeldehyde
M. Wt: 30
NO 2
HO
HO
Tris Nitro
Tri (hydroxymethyl) nitro methane
C4H9NO 5
M Wt: 151
(45) TRIS AMINO
Process Description:
Nitro methane react with formaldehyde 39% solution in presence of sodium carbonate gives Tris Nitro
crude which is further reduced by catalytic Hydrogenation followed by high vacuum distillation gives
Tris Amino.
(46) BUTAPHOSPHAN
Process Description:
n-butyl amine react with Acetone form Schiff bass and Schiff base react with Hypo phosphorous acid
gives Butaphosphan.
Chemical Reaction:
HO
Reaction Scheme : Butaphosphan
+
CH3COCH3
Acetone
M Wt: 58
O
H3C
NH2
n -Butylamine
C4H11N
M Wt :73
+
H
OH
H
P
H
Hypophosphorous Acid 80%
H3PO 2
M Wt : 66
CH3
+
P
NH
CH3
CH3
Butaphosphan
C7H18NO 2P
M Wt. 179
HO
+
H2O
18
(47) SUCRALFATE
Process Description:
Sucrose is reacted with chlorosulfonic acid in pyridine and Sodium Hydroxide get Sodium Salt which is
reacted with Aluminium chloro hydrate to get the required product.
Chemical Reaction:
Chlorosulfonic acid
OH
Aluminium chloro hydrate
OSO2ONH3
OSO2OAl(OH)2
o
8
Py 40 to 45 C
NH3
8
RT, 12hr
8
Sucrose
Sucralfate
Flow Chart:
Sucrose
Chlorosulfonic Acid
Pyridine, NH3
Aluminium Chloro Hydrate
Stage 1
Final product
(48) DARIFENACIN
Process Description:
The process starts reaction between 3-(S)-(+)-Hydroxypyrrolidine , a sulfonyl halide , and base in a
suitable solvent to obtain I-X-sulfonyl -3-(S)-(-) Xsulfonyloxypyrrolidine(III), then further reacting 1-Xsulfonyl-3-5-(-)-X-sulfonyloxypyrrolidine diphenyl acetonitrile and an in organic base in an organic
solvent to obtain (s)-2,2-dipheny 1-2-(1-X-sulfony 1-3-pyrrodinil)acetonitril salt. Then reaction reacts
with 2(2,3-dihydrobenzofuran-5-yl)ethyl chloride it converts into (S)-2{-(2,3-dihydrobenzofuran5-yl]-3pyrrolidinyl} -2,2-acetonitrito finally obtain derifenacin hydro bromide.
Chemical Reaction:
F
HO
(i)TEMPO (cat.)/
KBr/NaOCl/DCM
F
F
O
(ii) KI/Aq.HCl/Na2S2O3
F
F
F
F
F (i) Ti(iOPr) , THF
4
H2O
F
F
+ TiO2 + NaOH + B(OH)3 +
H
N
F
F
H3PO4/IPA
H
N
F
H
N
+
iPrOH
(ii) NaBH4
F
.H3PO4
NaCl
F
NH2
O
+
F
F
F
F
F
F
F
F
.H3PO4
H
N
(i)Aq. NaOH/DCM
(ii)MTBE.HCl/
Cyclohexane-MTBE
F
H
N
.HCl
+
Na3PO4
+
H2O
(49)
BENDROFLUMETHIAZIDE
Process Description:
Synthesis of bendroflumethiazide as a drugcomprises of two stages. In the first stage mamino
benzotrifluoride is sulphonated using chlorosulphonic acid in presence of sodium chloride in 1,1,2,2tetrachloroethane as a solvent.It is converted to sulphonamide derivative (TFDSA) by ammonolysis.In
the second stage disulphonamide derivative(TFDSA) is reacted with phenyl acetaldehydedimethyl
acetal in methanol-water system andglacial acetic acid as a catalyst. The resulting material is purified
water system toget required quality of bendroflumethiazide.
Chemical Reaction:
ANNEXURE – 6
WATER CONSUMPTION & WASTEWATER GENERATION DETAILS
Source of Water: GIDC Panoli (For Existing & Proposed)
Water Consumption (KL/day)
Sr.
No.
i.
Category
Domestic
Sub Total
ii.
Existing Additional
Wastewater Generation (KL/day)
Total After
Expansion
Existing
Additional
Total After
Expansion
0.50
1.50
2.00
0.40
1.20
1.60
0.50
1.50
2.00
0.40
1.20
1.60
15.00
15.00
Industrial
0.80
(ML 30-35% reused
in hydrated lime
solution & 65-70%
used in mfg. of
Magnesium
sulphate)
Process
4.85
12.00
16.85
Boiler
0.60
15.00
15.60
--
14.00
14.00
Cooling
0.20
9.80
10.00
--
1.00
1.00
Washing
--
5.00
5.00
--
4.50
4.50
Scrubber
--
1.00
1.00
--
0.70
0.70
Chilling Plant
--
1.00
1.00
--
--
--
--
0.50
0.50
--
0.50
0.50
--
0.50
0.50
--
0.50
0.50
5.65
44.80
50.45
--
36.20
36.20
0.50
1.50
2.00
--
--
--
Sub Total
0.50
1.50
2.00
--
--
--
GRAND TOTAL
(i + ii + iii)
6.65
47.80
54.45
0.40
37.40
37.80
Softener
(Backwash &
regeneration)
DM plant
(Regeneration &
Backwash)
Sub Total
iii.
Gardening
DISPOSAL OF WASTEWATER:
EXISTING:
1.
Domestic effluent is disposed in to Septic tank / Soak pit system.
2.
There is no generation & discharge of the industrial effluent from the manufacturing process
and other ancillary industrial operations. Hence, the unit is Zero Discharge.
PROPOSED:
1.
Domestic effluent shall be disposed in to Septic tank / Soak pit system.
2.
Industrial effluent generated from the manufacturing process and other ancillary industrial
operations will be treated into ETP and treated water will be evaporated through MEE.
3.
At present, unit has planned to install MEE for ZLD. However, in future as & when function of
CETP in this area will improved/installed & if GPCB will grant permission to discharge effluent
into CETP, mode of disposal will be of CETP after getting its permission.
ANNEXURE – 7
DESCRIPTION OF EFFLUENT TREATMENT PLANT
The Raw Effluent coming from the different stream will be collected in to collection tank. Then
after, effluent will be transferred into Reaction tank where dosing will be done with hydrated
lime and alum. The neutralized & flocculated effluent will be then transferred in a primary
settling tank (PST). In PST, sludge will be settled at bottom of the PST which will be sprayed
on sludge drying bed, while clear over flow will be carried out in treated water sump. After that,
primary treated water will be allowed in to the Multiple Effect Evaporator (MEE) and from
where water will be evaporated.
Sludge generated from sludge drying bed and Salt generated from MEE will be sent to TSDF
site.
NOTE: At present, unit has planned to install MEE for ZLD. However, in future as &
when function of CETP in this area will improved/installed & if GPCB will grant
permission to discharge effluent into CETP, mode of disposal will be of CETP
after getting its permission.
ANNEXURE – 8
STACK DETAILS
Stack Attached to
Stack
Height &
Dia.
Fuel
Consumption
Air
Pollution
Control
System
Parameters
Permissible
Limit
PM
SO 2
NO X
≤ 150 mg/NM3
≤ 100 ppm
≤ 50 ppm
PM
SO 2
NO X
≤ 150 mg/NM3
≤ 100 ppm
≤ 50 ppm
HCl
Cl 2
≤ 35 mg/Nm3
≤ 09 mg/Nm3
SO 2
H2S
Br 2
≤ 40 mg/Nm3
≤ 45 mg/Nm3
≤ 30 mg/Nm3
NH 3
≤ 25 mg/Nm3
EXISTING
Baby Boiler
(Capacity: 0.4 TPH)
Furnace for Evaporation
11.0 m &
0.20 m
9.0 m &
0.20 m
Natural Gas
40 m3/hr
Not
Required
Wood
200 kg/day
Water
Scrubber
PROPOSED
Steam Boiler
(Capacity: 1.0 TPH)
15.0 m &
0.30 m
Natural Gas
1000 SCM/day
Not
Required
Thermopack
(Capacity: 4.0 Lac kcal/hr)
15.0 m
&
0.30 m
Natural Gas
1000 SCM/day
Not
Required
D. G Set (Stand By)
(Capacity: 125 KVA)
3.0 m
&
0.10 m
HSD
35 Lit/hr
Not
Required
12.0 m
&
0.15 m
--
Water
Scrubber
followed by
Alkali
Scrubber
12.0 m
&
0.15 m
--
Ammonia
Recovery
System
Process Vent – 1
Process Vent – 2
Process Vent – 3
Note:
•
Unit will install one stand by D. G Set which will be used in case of power failure or
emergency.
•
HCl & SO 2 generated from reaction column will be scrubbed into water scrubber to recover
as a by-product. Alkali scrubber will be kept after water scrubber to neutralize process gas.
ANNEXURE – 9
HAZARDOUS/SOLID WASTE GENERATION & IT’S MANAGEMENT
Quantity
Sr.
No.
1.
Type of
Waste
ETP Sludge
2.
Used Oil
3.
Discarded
Containers /
Bags /
Liners
4.
Distillation
Residue
5.
Process
waste
6.
Spent Acid
7.
Spent
carbon
8.
Spent
Catayst
9.
10.
Spent Hyflo
MEE Salt
Category
34.3
5.1
Facility
Existing
Additional
Total After
Expansion
--
20.00
MT/year
20.00
MT/year
Collection, Storage,
Transportation and Disposal at
TSDF site – M/s. BEIL for
secured landfill.
0.30
MT/year
Collection, Storage,
Transportation, Disposal by
selling to Registered Rerefiners approved by
GPCB/CPCB.
0.10
MT/year
0.20
MT/year
0.70
MT/year
6.30
MT/year
7.00
MT/year
Collection, Storage,
Decontamination and Disposal
by selling to registered recyclers approved by
GPCB/CPCB.
--
6.00
MT/year
6.00
MT/year
Collection, Storage,
Transportation and Disposal at
TSDF site – for incineration.
28.1
--
1.00
MT/Year
1.00
MT/Year
Collection, Storage,
Transportation and Disposal at
TSDF site – for incineration.
Sch.II-D2
--
500.0
KL/Year
500.0
KL/Year
Collection, Storage,
Transportation & Sale to
authorized vendors / end users
--
10.00
MT/Year
10.00
MT/Year
Collection, Storage,
Transportation and Disposal at
TSDF site – M/s. BEIL for
secured landfill.
--
5.00
MT/Year
5.00
MT/Year
Collection, Storage,
Transportation and Disposal at
TSDF site – M/s. BEIL for
secured landfill.
33.3
20.3
28.2
28.2
28.2
--
--
5.00
MT/Year
5.00
MT/Year
Collection, Storage,
Transportation and Disposal at
TSDF Site – M/s. BEIL for
secured landfill.
--
100.00
MT/Year
100.00
MT/Year
Collection, Storage,
Transportation and Disposal at
TSDF Site – M/s. BEIL for
secured landfill.
PRE FEASIBILITY REPORT
FOR OBTAINING
PRIOR ENVIRONMENT CLEARANCE
FOR
ADDITION OF NEW PRODUCTS
IN THE EXISTING MANUFACTURING UNIT
OF
M/s. KEMPHAR INTERNATIONAL
LOCATED AT
Plot No. 3044, Road No. 30, 3rd Phase, GIDC Panoli,
Dist: Bharuch, State: Gujarat.
M/s. KEMPHAR INTERNATIONAL
PRE-FEASIBILITY REPORT
1. EXECUTIVE SUMMARY
M/s. KEMPHAR INTERNATIONAL is existing unit located at Plot No. 3044, Road No. 30,
3rd Phase, GIDC Panoli, Dist: Bharuch, State: Gujarat. The unit has proposed to produce
new products in addition of old product within existing premises.
Project is located within GIDC area and going for expansion in bulk drugs & intermediates.
Therefore, project falls under category B of schedule 5(f), as per the EIA Notification,
September 2006. Therefore, it requires prior Environment Clearance.
Electric power requirement for existing project is 65 HP, which is procured from DGVCL. It
is estimated that the additional power requirement for the proposed project will be 125 HP,
which will be also procured from DGVCL. One stand by D. G Set of capacity 125 KVA will
be installed which will be used in case of power failure or emergency.
Water required for domestic & industrial purpose is procured from GIDC. Domestic effluent
shall be disposed in to Septic tank / Soak pit system. At present, there is no generation &
discharge of the industrial effluent from the manufacturing process and other ancillary industrial
operations. Hence, the unit is Zero Discharge. After expansion, Industrial effluent generated from
the manufacturing process and other ancillary industrial operations will be treated into ETP and
treated water will be evaporated through MEE. At present, unit has planned to install MEE for ZLD.
However, in future as & when function of CETP in this area will improved/installed & if GPCB will
grant permission to discharge effluent into CETP, mode of disposal will be of CETP after getting its
permission.
Hazardous waste generated from the process and other industrial activity will be stored in
a separate hazardous waste storage area and then it will be disposed at nearest TSDF
site (M/s. BEIL) for secured land filling or disposed by selling to registered re-cyclers/rerefiners.
Proper safety will be provided during storage, handling and use of hazardous substance.
Portable Fire Extinguishers shall be provided at key location. Total area of project site is
1500.0 m2 and green belt area is 500.0 m2. At present, total 20 employees (18 Male + 2
Female) working at site. Due to expansion of project, Approx. 25 people (23 Male + 2
Female) will be required.
[1]
M/s. KEMPHAR INTERNATIONAL
PRE-FEASIBILITY REPORT
2. INTRODUCTION OF PROJECT / BACKGROUND INFORMATION
2.1 IDENTIFICATION OF PROJECT AND PROJECT PROPONENT
M/s. KEMPHAR INTERNATIONAL is existing unit located at Plot No. 3044, Road No. 30,
3rd Phase, GIDC Panoli, Dist: Bharuch, State: Gujarat. The unit has proposed to produce
new products in addition of old product within existing premises.
List of existing products and new products to be manufactured is as under;
LIST OF PRODUCT
Sr.
No.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
Name of Product
Choline Chloride Salt
Copper Sulphate
Ferrus Sulphate
Magnesium Sulphate
Zinc Sulphate
Potassium Chloride
Potassium Fluoride
Potassium Bromide
Sodium Bromide
Calcium Sulphate
Potassium Sulphate
Manganese Sulphate
Potassium Iodide
DI - Calcium Phosphate
TRI - Calcium Phosphate
P-Chloro Benzoic Acid
and/or
Allopurinol
and/or
Etodolac
and/or
Chloramphenicol
and/or
P-Hydroxy Benzaldehyde
and/or
Sulphadoxine
and/or
P-Amino Benzoic Acid
and/or
Ortho Cumidine
and/or
Nitro Amino Benzophenone
and/or
Nitro Chloro Benzoic Acid
and/or
Meta Amino Benzoic Acid
and/or
4 Methoxy Ethyl Phenol
and/or
Ariprazole
and/or
Existing
40.0
20.0
200.0
800.0
20.0
[2]
Quantity (MT/Month)
Proposed
Total After Expansion
-40.0
-20.0
-200.0
-800.0
-20.0
125.0
--
125.0
35.0
25.0
--
--5.0
35.0
25.0
5.0
--
2.0
2.0
--
2.0
2.0
--
3.0
3.0
--
5.0
5.0
--
2.0
2.0
--
3.0
3.0
--
2.0
2.0
--
3.0
3.0
--
3.0
3.0
--
4.0
4.0
--
3.0
3.0
--
2.0
2.0
M/s. KEMPHAR INTERNATIONAL
PRE-FEASIBILITY REPORT
Sr.
No.
29.
30.
31.
32.
33.
34.
35.
36.
37.
38.
39.
40.
41.
42.
43.
44.
45.
46.
47.
48.
49.
50.
51.
52.
53.
54.
55.
56.
57.
Quantity (MT/Month)
Name of Product
Existing
Proposed
Total After Expansion
--
1.0
1.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
3.0
3.0
--
3.0
3.0
--
2.0
2.0
--
1.5
1.5
--
1.5
1.5
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
--
2.0
2.0
Doxazosin Mesylate
and/or
Alfuzosin HCl
and/or
Tamsulosin HCl
and/or
Tolterodine Tartrate
and/or
Clonidine HCl
and/or
Amlodipine Besylate
and/or
Bendroflumethiazole
and/or
Losartan Potassium
and/or
Hydrochlorothiazide
and/or
Benazapril HCl
and/or
Telmisartan
and/or
Valsartan
and/or
Lacidipine HCl
and/or
Olmesartan Medoxomil
and/or
Lamotregence
and/or
Levetiracetam
and/or
Tiagabine HCl
and/or
Memantine HCl
and/or
Donepezil HCl
and/or
Phenylepherine HCl
and/or
Buprenorphine HCl
and/or
Meloxicam
and/or
Larnoxicam
and/or
Pregabalin
and/or
Gabapentin
and/or
Celecoxib
and/or
Pioglitazone HCl
and/or
Cetirizine HCl
and/or
Fexofenadine HCl
and/or
[3]
M/s. KEMPHAR INTERNATIONAL
PRE-FEASIBILITY REPORT
Sr.
No.
58.
59.
60.
61.
62.
63.
64.
65.
66.
67.
68.
69.
70.
Quantity (MT/Month)
Name of Product
Existing
Proposed
Total After Expansion
--
2.0
2.0
--
50.0
50.0
--
5.0
5.0
--
3.0
3.0
--
50.0
50.0
--
3.0
3.0
--
2.0
2.0
--
2.0
2.0
--
3.0
3.0
--
2.0
2.0
--
5.0
5.0
--
5.0
5.0
--
15.0
15.0
Aldendronate sodium
and/or
Tris Nitro
and/or
Tris Amino
and/or
Butaphosphan
and/or
Sucralfate
and/or
Doxazosin
and/or
Alfuzosin HCl
and/or
Darifenacin
and/or
Amlodipine
and/or
Bendroflumethiazide
and/or
Dinitolmide
and/or
Roxarsone
and/or
Bis(2-Chloroethyl) Amine HCl
NOTE: For proposed new products, total production capacity shall not exceed
200 MT/Month.
2.2 NATURE OF THE PROJECT
M/s. Kemphar International is a small scale unit. It covers under the category of bulk
drugs & intermediates industry.
2.3 EMPLOYMENT GENERATION (DIRECT & INDIRECT) DUE TO THE
PROJECT
Due to expansion of project, employment will be generated. At present, total 20 employees
(18 Male + 2 Female) working at site. Due to expansion of project, Approx. 25 people (23
Male + 2 Female) will be required.
[4]
M/s. KEMPHAR INTERNATIONAL
PRE-FEASIBILITY REPORT
3. PROJECT DESCRIPTION
3.1 TYPE OF PROJECT
The unit will involve in manufacturing of bulk drugs & intermediates.
3.2 LOCATION
The site is located at about 21°32'43.19"N Latitude and 72°59'28.06"E Longitude.
LOCATION OF THE PROJECT
[5]
M/s. KEMPHAR INTERNATIONAL
PRE-FEASIBILITY REPORT
3.3 DETAILS OF ALTERNATE SITES
No alternative sites examined as project is located within GIDC area.
3.4 SIZE / MAGNITUDE OF OPERATION
M/s. Kemphar International is a small scale unit. For proposed new products, total
production capacity shall not exceed 200 MT/Month.
3.5 PROJECT DESCRIPTION WITH PROCESS DETAILS
Project description with process and mass balance is attached in Annexure – 5 of EC
application.
3.6 RAW MATERIAL WITH REQUIRED QUANTITY, SOURCE, MARKETING
AREA OF FINAL PRODUCTS, MODE OF TRANSPORT OF RAW MATERIAL
AND FINISHED PRODUCT
For Product and Raw material with required quantity, please refer Annexure – 4 of EC
application and for storage details of raw material & product and mode of transportation,
please refer Annexure – 4 of EC application.
3.7 AVAILABILITY OF WATER, ITS SOURCE, ENERGY / POWER
REQUIREMENT AND SOURCE
Source of Water: GIDC Panoli (For Existing & Proposed)
Sr.
No.
i.
Water Consumption (KL/day)
Category
Existing
Additional
Total After Expansion
0.50
1.50
2.00
0.50
1.50
2.00
Process
4.85
12.00
16.85
Boiler
0.60
15.00
15.60
Cooling
0.20
9.80
10.00
Washing
--
5.00
5.00
Scrubber
--
1.00
1.00
Chilling Plant
--
1.00
1.00
Softener (Backwash & regeneration)
--
0.50
0.50
DM plant (Regeneration & Backwash)
--
0.50
0.50
5.65
44.80
50.45
0.50
1.50
2.00
Sub Total
0.50
1.50
2.00
GRAND TOTAL (i + ii + iii)
6.65
47.80
54.45
Domestic
Sub Total
ii.
Industrial
Sub Total
iii.
Gardening
[6]
M/s. KEMPHAR INTERNATIONAL
PRE-FEASIBILITY REPORT
Energy / Power Requirement & Its Source
Electric power requirement for existing project is 65 HP, which is procured from DGVCL.
Additional power requirement for the proposed project will be 125 HP, which will be also
procured from DGVCL.
One stand by D. G Set of capacity 125 KVA will be installed which will be used in case of
power failure or emergency.
3.8 QUANTITY OF WASTES TO BE GENERATED (LIQUID AND SOLID) AND
SCHEME FOR THEIR MANAGEMENT / DISPOSAL
(A) Quantity of Liquid Waste to be Generated & Its Management / Disposal:
Wastewater Generation (KL/day)
Sr.
No.
i.
Category
Domestic
Sub Total
ii.
Existing
Additional
Total After
Expansion
0.40
1.20
1.60
0.40
1.20
1.60
15.00
15.00
Industrial
0.80
(ML 30-35% reused in
hydrated lime solution &
65-70% used in mfg. of
Magnesium
sulphate)
Process
Boiler
--
14.00
14.00
Cooling
--
1.00
1.00
Washing
--
4.50
4.50
Scrubber
--
0.70
0.70
Chilling Plant
--
--
--
Softener (Backwash & regeneration)
--
0.50
0.50
DM plant (Regeneration & Backwash)
--
0.50
0.50
--
36.20
36.20
--
--
--
--
--
--
0.40
37.40
37.80
Sub Total
iii.
Gardening
Sub Total
GRAND TOTAL (i + ii + iii)
DISPOSAL OF WASTEWATER:
EXISTING:
1.
Domestic effluent is disposed in to Septic tank / Soak pit system.
2.
There is no generation & discharge of the industrial effluent from the manufacturing process
and other ancillary industrial operations. Hence, the unit is Zero Discharge.
[7]
M/s. KEMPHAR INTERNATIONAL
PRE-FEASIBILITY REPORT
PROPOSED:
1.
Domestic effluent shall be disposed in to Septic tank / Soak pit system.
2.
Industrial effluent generated from the manufacturing process and other ancillary industrial
operations will be treated into ETP and treated water will be evaporated through MEE.
3.
At present, unit has planned to install MEE for ZLD. However, in future as & when function of
CETP in this area will improved/installed & if GPCB will grant permission to discharge effluent
into CETP, mode of disposal will be of CETP after getting its permission.
(B) Quantity of Hazardous/Solid Waste to be Generated & Its Management /
Disposal:
Quantity
Sr.
No.
Type of
Waste
Category
1.
ETP Sludge
2.
Used Oil
Facility
Existing
Additional
Total After
Expansion
34.3
--
20.00
MT/year
20.00
MT/year
Collection, Storage, Transportation
and Disposal at TSDF site – M/s. BEIL
for secured landfill.
5.1
0.10
MT/year
0.20
MT/year
0.30
MT/year
Collection, Storage, Transportation,
Disposal by selling to Registered Rerefiners approved by GPCB/CPCB.
3.
Discarded
Containers /
Bags /
Liners
33.3
0.70
MT/year
6.30
MT/year
7.00
MT/year
Collection, Storage, Decontamination
and Disposal
by selling to registered re-cyclers
approved by GPCB/CPCB.
4.
Distillation
Residue
20.3
--
6.00
MT/year
6.00
MT/year
Collection, Storage, Transportation and
Disposal at TSDF site – for incineration.
5.
Process
waste
28.1
--
1.00
MT/Year
1.00
MT/Year
Collection, Storage, Transportation and
Disposal at TSDF site – for incineration.
6.
Spent Acid
Sch.II-D2
--
500.0
KL/Year
500.0
KL/Year
Collection, Storage, Transportation &
Sale to authorized vendors / end users
7.
Spent
carbon
28.2
--
10.00
MT/Year
10.00
MT/Year
Collection, Storage, Transportation
and Disposal at TSDF site – M/s. BEIL
for secured landfill.
8.
Spent
Catayst
28.2
--
5.00
MT/Year
5.00
MT/Year
Collection, Storage, Transportation
and Disposal at TSDF site – M/s. BEIL
for secured landfill.
9.
Spent Hyflo
28.2
--
5.00
MT/Year
5.00
MT/Year
Collection, Storage, Transportation
and Disposal at TSDF Site – M/s. BEIL
for secured landfill.
10.
MEE Salt
--
--
100.00
MT/Year
100.00
MT/Year
Collection, Storage, Transportation
and Disposal at TSDF Site – M/s. BEIL
for secured landfill.
[8]
M/s. KEMPHAR INTERNATIONAL
PRE-FEASIBILITY REPORT
(C) Stack Details:
Stack Attached to
Stack
Height &
Dia.
Fuel
Consumption
Air
Pollution
Control
System
Parameters
Permissible
Limit
PM
SO 2
NO X
≤ 150 mg/NM
≤ 100 ppm
≤ 50 ppm
3
PM
SO 2
NO X
≤ 150 mg/NM
≤ 100 ppm
≤ 50 ppm
3
HCl
Cl 2
≤ 35 mg/Nm
3
≤ 09 mg/Nm
SO 2
H2S
Br 2
≤ 40 mg/Nm
3
≤ 45 mg/Nm
3
≤ 30 mg/Nm
NH 3
≤ 25 mg/Nm
EXISTING
Baby Boiler
(Capacity: 0.4 TPH)
11.0 m &
0.20 m
Natural Gas
3
40 m /hr
Not Required
Furnace for Evaporation
9.0 m &
0.20 m
Wood
200 kg/day
Water
Scrubber
PROPOSED
Steam Boiler
(Capacity: 1.0 TPH)
15.0 m
&
0.30 m
Natural Gas
1000 SCM/day
Thermopack
(Capacity: 4.0 Lac kcal/hr)
15.0 m
&
0.30 m
Natural Gas
1000 SCM/day
Not Required
D. G Set (Stand By)
(Capacity: 125 KVA)
3.0 m
&
0.10 m
HSD
35 Lit/hr
Not Required
12.0 m
&
0.15 m
--
Water
Scrubber
followed by
Alkali
Scrubber
12.0 m
&
0.15 m
--
Ammonia
Recovery
System
Process Vent – 1
Process Vent – 2
Process Vent – 3
[9]
Not Required
3
3
3
M/s. KEMPHAR INTERNATIONAL
PRE-FEASIBILITY REPORT
4. SITE ANALYSIS
4.1 CONNECTIVITY
The project site is well connected with all infrastructures like National Highway, Railway,
Airport, telephone, internet, fax, post, etc.
• Nearest city is Panoli located 2.00 km in SW direction from the project site.
• National Highway-8 is located 1.63 km in E direction.
• Nearest railway station is Panoli Railway Station located 1.66 km in SW direction from
the project site.
• Nearest airport is Surat Airport located 52.46 km in SW direction from the project site.
4.2 LAND FORM, LAND USE AND LAND OWNERSHIP
The land is non agriculture and allotted by GIDC. The land is totally flat. The ownership of
the land is unit itself.
LAND AREA BIFURCATION
Sr.
No.
Area (m2)
Title
1.
Raw material storage area
185.00
2.
Finished product storage area
192.00
3.
Process area
298.00
4.
ETP area
30.00
5.
Boiler area
16.00
6.
D. G Set area
12.00
7.
Hazardous waste storage area
45.00
8.
Office
48.00
9.
Laboratory
24.00
10.
Green belt area
500.00
11.
Open space
150.00
TOTAL
1500.00
4.3 TOPOGRAPHY
For Topography map, please refer Annexure – 1 of EC application.
[10]
M/s. KEMPHAR INTERNATIONAL
PRE-FEASIBILITY REPORT
4.4 EXISTING LAND USE PATTERN, SHORTEST DISTANCE FROM THE
PERIPHERY OF THE PROJECT TO PERIPHERY OF THE FOREST,
NATIONAL PARK, WILD LIFE SANCTUARY, ECO SENSITIVE AREA,
WATER BODIES (DISTANCE FROM THE HFL OF THE RIVER), CRZ
The land is non agriculture. The project site is located in GIDC area. There is no forest,
wild life sanctuary, eco sensitive area within 10 km from the project site. The details of
water bodies and nearest park are mentioned below:
•
Arabian Sea is 41.78 km in W direction.
•
Narmada River is 14.60 km in NW direction.
•
Black Buck National Park, Velavadar is 114.51 km in NW direction.
•
Shoolpaneshwar Wildlife Sanctuary is 57.28 km in NE direction.
4.5 EXISTING INFRASTRUCTURE
No new land will be required for proposed project activity. Expansion will be done within
existing premises.
The project site is well connected with all infrastructures like Highway, Railway, Airport,
telephone, internet, fax, post, etc.
4.6 SOCIAL INFRASTRUCTURE AVAILABLE
The project is located in GIDC area. GIDC has developed power supply, water supply,
pucca road, telephone & other communication network, transporters godown & drainage
network in the area. Skilled & unskilled manpower available within area. Ambulance and
emergency fire & medical service available round the clock.
[11]
M/s. KEMPHAR INTERNATIONAL
PRE-FEASIBILITY REPORT
5. PROJECT SCHEDULE & COST ESTIMATES
5.1 LIKELY DATE OF START OF CONSTRUCTION AND LIKELY DATE OF
COMPLETION
The unit is existing. Production of new products shall be started after getting Environment
Clearance and Consent.
5.2 PROJECT COST ESTIMATION
Estimated cost for the proposed project is Rs. 3.0 Crore.
[12]