PRE FEASIBILTY REPORT -...

of 49

M/s Embio Limited, Mahad PJ No -1/2015

Document Title: PRE FEASIBILITY REPORT Facility Description: NEW FACILITY AT DAHEJ DOC.NO. – P-G-01/16 Date: 01 MARCH 2016 Rev - 0

PRE FEASIBILTY REPORT

of 49



INDEX 1. Executive Summary

2. Introduction of the Project / Background information 3. Project Description 4. Site Analysis 5. Planning Brief 6. Proposed Infrastructure 7. Rehabilitation and Resettlement (R & R) Plan 8. Project Schedule & Cost Estimates 9. Analysis of Proposal (Final Recommendations)

of 49



1.0 EXECUTIVE SUMMARY

M/s. Embio Ltd. intends to set up a Greenfield facility for various categories of pharmaceutical APIs & Intermediates, Animal health products, Alkaloids Extraction, Opioids & Non-opioids APIs and Finished Dosages manufacturing facility at Dahej, Gujarat. It is intended that the latter part of manufacturing operations which involves handling of Opioids and other associated drugs would be carried out with the technical knowhow from a foreign collaborator. Some of the finished products fall under the Controlled Substances category and hence the manufacturing facility will be designed and built keeping all the stringent regulations in mind. This ‘PRE FEASIBILTY REPORT’ will be the basis for the finalization for Project objectives, basic designs and shall deliver a cost estimate of this project, along with time schedule for completion of the project.

of 49



2.0 INTRODUCTION OF THE PROJECT 2.1 Identification of project and project proponent.

Embio Ltd. is one of the reputed manufacturing companies in India having their manufacturing facility at Mahad, Maharashtra. The existing facility is being used for manufacturing of fermentation products, APIs, Intermediates, Animal health products and some small volume high value API products.

For similar purpose, Embio Ltd has acquired around 25 acres of land at Dahej in Gujarat. A brief concept has been worked out as below to substantiate the total land usage by the company. LOCATION M/s. Embio Limited is planning to for the establishment of new unit at plot no. 3/3/2, Dahej-III, Taluka Vagra, District Bharuch, Gujarat. Below map is showing location of the project site. Latitude - 21°44'32.49" North Longitude - 72°36'57.87" East LOCATION MAP

of 49



2.2 Brief description & nature of the project. :

It is primarily identified that following facilities would be constructed in the proposed manufacturing set up. 1.0 Animal health API Block 2.0 Multipurpose API Block 3.0 Small Volume API Plant 4.0 CPS Pallets Extraction Plant 5.0 Value Added API Plant 6.0 Finished Dosages Plant 7.0 Support Functions like QA/QC, Admin, Utilities, Tank Farm, ETP

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

The present facility at Mahad in Maharashtra has been almost fully utilized to serve the ever increasing market demands and there is no scope for any further expansions. To cater the increasing product demands, Embio feels a need to set up another manufacturing facility at some other convenient place. Further, Embio Ltd is also in advance stages of development of opioid based products for pain management segment. To undertake the in house expansions and to facilitate the manufacturing of the above products, Embio Ltd has acquired a land at bearing Plot No. 3/3/2 in Dahej III, GIDC Area, Gujarat, which is the most preferred location over other sites. 2.4 Demand-Supply Gap.

As stated earlier the present facility is not fulfilling the market requirement, So it is necessary to set up a new facility to fulfill the market requirement. 2.5 Imports vs. Indigenous production.

The sole production is indigenous. The required raw material is of both imported as well as indigenous.

of 49



2.6 Export Possibility.

Most of the products have export potential.

2.7 Domestic / Export Markets.

As the facility will be for multi products in the range of APIs and animal health products, it will have both Domestic as well as Export Markets.

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

Sr. No Description

Requirements

5 Years 6 to 10 Years 11 to 15 Years

1 No of skilled employees 96 121 150

2 No. of unskilled employees 30 50 75

3 No. of supervisory employees 120 150 180

Total 246 321 405

of 49



3.0 PROJECT DESCRIPTION

3.1 Introduction M/s. Embio Ltd. intends to set up a Greenfield facility for various categories of APIs, Alkaloids Extraction, opioid/ non-opioid APIs and Finished Dosages manufacturing facility at Dahej, Gujarat. The proposed project falls under Category “B” inside notified industrial area, Project or Activity 5(f), synthetic organic chemical industries. The facility will have following: 1. Extraction Building 2. Solvent Management Building 3. API Manufacturing Blocks 4. Finished Dosages plant 5. Secured Storage for FG 6. Utility Building 7. Admin/QC Block 8. General Storage Building 9. Effluent treatment facility 3.2 Project Objectives The objective of the project is to conceive a new Alkaloid Extraction & API manufacturing facility for various products developed in-house and with technical knowhow from foreign collaborators. The proposed facility will be constructed at once for the currently identified production capacities. The land requirement is estimated around 25 acres. 3.3 Project Features The project planning exercise takes shape by systematically covering following aspects: 3.3.1 Design Guidelines The Alkaloid Extraction along with the solvent processing section shall be designed as per local industrial guidelines. The API manufacturing plant shall be designed as per cGMP requirements. Advanced technology, latest equipments, enhanced safety and ease of operations and maintenance will be adopted in the facility design. Facility shall be designed for 24 hours operation per day & 350 days a year.

of 49



The facility design shall eliminate the possibilities of cross-contamination, particularly in API manufacturing. This encompasses not only production procedure and cleaning, but also the layout, personnel, material transition and material handling. The API production suite layout involves incorporating optimum layouts for Bulk and Powder Processing from the view point of men and material movement and the current good manufacturing practices (cGMP). Common man entry with change room is envisaged for All the Storage, Manufacturing and the Lab areas. Man will change from street clothes to facility clothes in these change rooms. Visitors will only be required to wear gown. As the API manufacturing is proposed to be a cGMP compliant building, there will be additional Change Rooms/Air Locks for next level of gowning while entering into the individual sections as required. Philosophy of Material entry is different for each Manufacturing/Processing block as per the individual process requirement. In API manufacturing block, each section will have dedicated material Air Lock if the material is transferred in bins and or to be carried manually. A material Hoist is planned only in API block where there will be some material transfer in bins/containers apart from transfer through pipes/by vacuum. In rest of the processing/ storage sections the material will be either transferred by means of pumping or with the help of vacuum system. HVAC system for the manufacturing and warehousing areas to suit the requirements of Heating, Ventilation and Air Conditioning. Also, Dust extraction, necessary number of air changes, containment and pressure gradients shall be adequately designed to prevent cross contaminations, solvent vapour accumulation and human uncomfort. HT switch yard with Low Voltage transformation and further downstream distribution is planned for Electrical Power that will be required to operate the process & utility services. Diesel Generator sets shall be planned to ensure 100% power back up for the facility. Utilities shall be designed for the present requirements with a space allocation to serve the future loads. Utility header sizes shall be designed for full load capacities of the present and future plants. 3.3.2 Design Features There shall be an equal focus on achieving other desired features listed below: Costs The plant has to be designed to have low running costs. The investment costs for the new plant must be within the reasonable limits. The projected return on investment must be over a reasonable time scale.

of 49



Flexibility Although, the plant will be set up to meet specific process requirements, it can be utilized to produce multiple products in similar category with no or minimal changes in the set up depending on the process specifications. Expansion The site plan will have flexibility for future expansions of the plant and will also have space for construction of completely new production facilities as well. The new plant should be designed in a way so that the extension / expansion of the building should be achievable without major interruption to the production. The Water System to be as per the USP/EU GMP Grade The quality of the water used in the production is a key parameter. Depending upon the end use and the nature of the downstream processing, the quality of the water required can vary from general process/drinking water to purified water. The Plant to have Suitable Safety Features The materials being handled are potent and highly hazardous in nature. A high level of protection needs to be provided during handling of material and controlling the unit operations / reactions. Considerable attention needs to be given to all aspects of safety, both for the personnel and the environment. The facility shall be designed for class product as per OSHA. Proper design for cleaning and validation to be provided as per requirements. The efficacy of the cleaning procedures and the cleaning frequency must be properly validated and given a high priority. Also, ‘potent’ molecules are formed / to be handled during some production stages. Hence, various process streams as well as washings are to be suitably treated / detoxified in suitable manner at the nearest possible location of its generation, before final disposal.

of 49



3.1 Location (map showing general location, specific location, and project boundary & project site layout) with co-ordinates.

of 49



3.4 Size or magnitude of operations.

Sr. No. DESCRIPTION PRODUCTION QUANTITY UNIT

A MULTIPURPOSE API

Oxalate for nor products

1 L-Nor Ephedrine HCL 50 MT/YEAR

2 L-Nor Ephedrine Base 25 MT/YEAR

3 P-Nor Ephedrine HCL 20 MT/YEAR

2 P-Nor Ephedrine Base 50 MT/YEAR

4 D-Nor Pseudo Ephedrine HCL 5 MT/YEAR

B ANIMAL FEED

1 Octopamine HCL 72 MT/YEAR

2 Ractopamine HCL 50 MT/YEAR

C Enzyme based fermentation products

1 10kl fermenter - 2 Nos. 14.66 MT/YEAR

2 20Kl fermenter - 2Nos. 29.33 MT/YEAR

D PAIN MANAGEMENT PRODUCTS

1 Codeine 80 MT/YEAR

2 Morphine 35 MT/YEAR

3 Hydrocodone 22 MT/YEAR

4 Oxycodone 22 MT/YEAR

5 Methadone 5 MT/YEAR

6 Fentanyl 5 MT/YEAR

of 49



3.5 Project description with process details (a schematic diagram / flow chart showing the project layout, components of the project etc. should be given) MULTIPURPOSE API 3.5.1 P NOR HCl & P NOR Base 3.5.1.1 Oxime Preparation For preparation of oxime, potable water, HAH, caustic lye (48 %), Phenyl Acetyl Carbinol (PAC), Hydrochloric acid, & recovered toluene from previous batches are added in a SS reactor. The oxime is then transferred to Hydrogenator for Hydrogenation. 3.5.1.2 Hydrogenation & filtration Pre weighed quantity of Methanol & Caustic lye (48 %) is added to the oxime. The pre weighed quantity of catalyst is also added. Then Hydrogen gas is added slowly in the Hydrogenator from Hydrogen Cylinder bank with suitable pressure reducing station. After the completion of Hydrogenation, the reaction mass is filtered to separate the catalyst. The filtered reaction mass is taken into a SS reactor for further processing. 3.5.1.3 Distillation, crude base preparation & centrifugation In stainless steel reactor, initially the methanol is separated by distillation. After the removal of Methanol, pre weighed quantity of Toluene & DM water acid is added & agitation is continued .oxalic acid is added to precipitate the reaction mass which shall be taken for centrifuging. DM water is used to wash the reaction mass. The oxalate salt cake is then taken for Basification & Extraction. 3.5.1.4 Basification & Extraction To the oxalate salt cake, Pre weighed quantity of Toluene, Potassium hydroxide (KOH), BC4 & water is added for basification & extraction process. The aqueous layer is drained & the organic layer is further processed. 3.5.1.5 Hydro chlorination & Bleaching To the organic layer pre weighed quantity of Activated carbon, HCL, & water is added to again form aqueous layer & Organic layer. The Organic layer is drained & aqueous layer is further processed. 3.5.1.6 Distillation & Centrifugation To the aqueous layer Toluene & Acetone is added for further processing. The distillation is carried out to separate the product P NOR HCL. 3.5.1.7 Basification & Filtration To the remaining contents in the reactor, Caustic lye & water is added for basification process. The reaction mass is then centrifuged to get the P NOR Base cake.

of 49



3.5.2 L NOR HCl & L NOR Base 3.5.2.1 Oxime Preparation For preparation of oxime, potable water, HAH, caustic lye (48 %) Phenyl Acetyl Carbinol (PAC), Hydrochloric acid & recovered toluene from previous batches is added in a SS reactor. The oxime is then transferred to Hydrogenator for Hydrogenation. 3.5.2.2 Hydrogenation & filtration Pre weighed quantity of Methanol & Caustic lye (48 %) is added to the oxime, the pre weighed quantity of catalyst is also added. Then Hydrogen gas is added slowly in the Hydrogenator from Hydrogen Cylinder bank with suitable pressure reducing station. After the completion of Hydrogenation, the reaction mass is filtered to separate the catalyst. The filtered reaction mass is taken into a SS reactor for further processing. 3.5.2.3 Distillation, crude base preparation & centrifugation In stainless steel reactor, initially the methanol is separated by distillation. After the removal of Methanol, pre weighed quantity of Toluene & DM water acid is added & agitation is continued .oxalic acid is added to precipitate the reaction mass which shall be taken for centrifuging. DM water is used to wash the reaction mass. The oxalate salt cake is then taken for Basification & Extraction. 3.5.2.4 Basification & Extraction To the oxalate salt cake, Pre weighed quantity of Toluene, Potassium hydroxide (KOH), & water is added for basification & extraction process. The aqueous layer is drained & the organic layer is further processed. 3.5.2.5 Hydro chlorination & Bleaching To the organic layer pre weighed quantity of Activated carbon, HCL, & water is added to again form aqueous layer & Organic layer. The Organic layer is drained & aqueous layer is further processed. 3.5.2.6 Distillation & Centrifugation To the aqueous layer Toluene & Acetone is added for further processing. The distillation is carried out. The reaction mass is then centrifuged to get the product L NOR HCL cake. 3.5.2.7 Basification & Filtration To the remaining contents in the reactor, Petroleum Ether & water is added for basification process. The reaction mass is then centrifuged to get the LNOR Base cake. 3.5.3 D NOR Pseudo Ephedrine HCL 3.5.3.1 Oxime Preparation For preparation of oxime, potable water, HAH, caustic lye (48 %) Phenyl Acetyl Carbinol (PAC), hydrochloric acid & recovered toluene from previous batches is added in a SS reactor.

of 49



The oxime is then transferred to Hydrogenator for Hydrogenation. 3.5.3.2 Hydrogenation & filtration Pre weighed quantity of Methanol & Caustic lye (48 %) is added to the oxime. The pre weighed quantity of catalyst is also added. Then Hydrogen gas is added slowly in the Hydrogenator from Hydrogen Cylinder bank with suitable pressure reducing station. After the completion of Hydrogenation, the reaction mass is filtered to separate the catalyst. The filtered reaction mass is taken into a SS reactor for further processing. 3.5.3.3 Distillation, crude base preparation & centrifugation In stainless steel reactor, initially the methanol is separated by distillation. After the removal of Methanol, pre weighed quantity of Toluene & DM water acid is added & agitation is continued .oxalic acid is added to precipitate the reaction mass which shall be taken for centrifuging. DM water is used to wash the reaction mass. The oxalate salt cake is then taken for Basification & Extraction. 3.5.3.4 Basification & Extraction To the oxalate salt cake, Pre weighed quantity of Toluene, Potassium hydroxide (KOH), & water is added for basification & extraction process. The aqueous layer is drained & the organic layer is further processed. 3.5.3.5 Acetylation & hydrolysis To the organic layer pre weighed quantity of acetic anhydride, H2So4, & DM water is added. Acetic acid is recovered in the process & for further reaction mass is taken for basification & extraction. 3.5.3.6 Basification & extraction To the reaction mass, Pre weighed quantity of Toluene, Isopropyl alcohol, acetic acid & caustic lye is added for basification & extraction process. Toluene is recovered by distillation. After the removal of toluene, reaction mass is further processed for hydro chlorination & bleaching. 3.5.3.7 Hydro chlorination & Bleaching To the reaction mass, pre weighed quantity of Activated carbon, toluene, Acetone & DM water is added to again form aqueous layer & Organic layer. The Organic layer is drained & aqueous layer is further processed. 3.5.3.8 Distillation & Centrifugation To the aqueous layer Toluene & Acetone is added for further processing. The distillation is carried out to separate the product D NOR Pseudo Ephedrine HCL.

of 49



Animal Health Products 3.5.2.1 Ractopamine HCl 3.5.2.1.1 Hydrogenation & filtration Initially purge the Hydrogenator with Nitrogen gas to create an inert atmosphere. Then pre weighed quantity of reactants like, Methanol, Octopamine HCL, and RK & Triethyl amine are added as per the recipe sequence. The pre weighed catalyst is also added. Then Hydrogen gas is added slowly in the Hydrogenator from Hydrogen Cylinder bank with suitable pressure reducing station. After the completion of Hydrogenation, the reaction mass is filtered to separate the catalyst. The filtered reaction mass is taken into a Glass lined reactor for further processing.

of 49



3.5.2.1.2 Distillation In Glass lined reactor, initially the methanol is separated by distillation. After the removal of Methanol, pre weighed quantity of DM water & HCL is added & agitation is continued. Then the reaction mass is extracted with Ethyl acetate. The required layer is then transferred to SS reactor where it is bleached with Activated carbon. After bleaching , the reaction mass is filtered through a sparkler filter , & taken in glass lined reactor. HCL is added to precipitate the reaction mass which shall be taken for centrifuging. DM water is used to wash the reaction mass. The cake is then taken for Drying. 3.5.2.1.3 Drying, sifting, milling & Blending Fluidized bed dryer is used for drying of the product. The dried product is then sieved in the sifter & milled in the mill. The milled product is further blended before packing. 3.5.2.2 DL-Octopamine HCl 3.5.2.2.1 Hydrogenation & filtration Initially purge the Hydrogenator with Nitrogen gas to create an inert atmosphere. Then pre weighed quantity of reactants like, AK HCl & DM water are added as per the recipe sequence. The pre weighed catalyst is also added. Then Hydrogen gas is added slowly in the Hydrogenator from Hydrogen Cylinder bank with suitable pressure reducing station. After the completion of Hydrogenation, the reaction mass is filtered to separate the catalyst. The filtered reaction mass is taken into a SS reactor for further processing. 3.5.2.2.2 Bleaching , Filtration, Concentration & Dilution In SS reactor, initially the methanol is separated by distillation. After the removal of Methanol where it is bleached with Activated carbon. After bleaching, the reaction mass is filtered through a sparkler filter, & taken in glass lined reactor. Acetone is added to the reaction mass, which shall be taken for centrifuging. Acetone is used to wash the reaction mass. The cake is then taken for Drying. 3.5.2.2.3 Drying, sifting & milling Fluidized bed dryer is used for drying of the product. The dried product is then sieved in the sifter & milled in the mill. The milled product is further blended before packing.

of 49



Block Diagram for Animal Health Products

of 49



POPPY STRAW PROCESSING Step I: Extraction of Poppy straw pellets to produce technical grade morphine

Mass balance per Ton of Poppy straw pellet input Gaseous Emissions-

Poppy Straw 1. Product: Tech. Morphine pellets 2. Product: Codeine

Ethanol 3. Product: Thebaine: Water 4. Recovered Ethanol: Toluene 5. Recovered n-Butanol Sodium Hydroxide 6. Recovered toluene: n-Butanol Sulfuric acid Waste Water Solid Waste (spent poppy straw)

of 49



PRODUCTION OF CODEINE PHOSPHATE FROM MORPHINE/CODEINE

Step I: Conversion of Tech. morphine into codeine base; Step II: Conversion of Codeine base into Codeine Phosphate

Gaseous Emissions-

Tech. Morphine: 1. Product: Codeine PO4 Trimethyl phenyl 2. Recovered Ethanol:

ammonium 3. Recovered Toluene: Chloride: Toluene Sodium Hydroxide Water Ethanol Phosphoric acid Activated carbon Waste Water Solid waste: Spent carbon

of 49



PRODUCTION OF MORPHINE SULPHATE FROM TECH. MORPHINE

Step I: Conversion of Tech. morphine into codeine base; Step II: Conversion of Codeine base into Codeine Phosphate

Gaseous Emissions

Tech. Morphine: 1. Product: Morphine SO4 Sulphuric acid 2. Recovered Ethanol Ethanol Water Activated carbon Waste Water Solid waste

of 49



PRODUCTION OF HYDROCODONE BITARTRATE FROM THEBAINE

Step I: Conversion of Thebaine to Codeinone; Step II: Conversion of Codeinone into Hydrocodone Bitartrate Gaseous Emissions

Thebaine: 1. Hydrocodone Bitartrate Hydrochloric acid: 2. Recovered Toluene d-Tartaric acid: 3. Recovered Ethanol Ethanol Toluene Water Activated carbon Waste Water – Solid waste: Spent carbon

of 49



PRODUCTION OF OXYCODONE HYDROCHLORIDE FROM THEBAINE

Step I: Conversion of Thebaine to 14-Hydroxycodeinone; Step II: Conversion of 14-Hydroxycodeinone into Oxycodone Hydrochloride

Gaseous Emissions Thebaine: 1. Oxycodone Hydrochloride Hydrogen peroxide: 2. Recovered Toluene Formic acid: Water Toluene Hydrochloric acid Pd-C Catalyst Activated carbon Waste Water Solid Waste: Spent carbon

of 49



Methadone HCl Step I: Preparation of DCN Base: Gaseous Emissions Diphenylacetonitrile DCN Base Dimethylamino isopropyl Recovered petr. ether Chloride HCl Recovered Toluene Caustic soda HCl Liquor ammonia Toluene Petroleum ether Water

ML or Waste Water

Step II: Preparation of Methadone HCl:

Gaseous Emissions DCN Base Methadone HCl Magnesium metal Diethyl ether Recovered Toluene Caustic soda HCl Recovered Acetone Activated carbon Toluene Spent carbon Ethyl bromide Water Acetone

of 49



ML or Waste Water

Fentanyl Citrate

Step I: 1-Benzyl-4-anilinopiperidine: Gaseous Emissions 1-Benzyl-4-piperidone 1-Benzyl-4-anilinopiperidine Aniline Recovered Methanol Sodium borohydride Recovered Toluene Methanol HCl Liquor ammonia Toluene Water

ML or Waste Water Step II: N-(1-benzylpiperidin-4-yl)-N-phenylpropanamide: Gaseous Emissions 1-Benzyl-4-anilinopiperidine N-(1-benzylpiperidin-4-yl) -N-phenylpropanamide 95 kg Propionic anhydride Recovered Toluene 270 kg Sodium hydride Sodium chloride Toluene

of 49



HCl Water ML or Waste Water Step III: N-phenyl-N-(piperidin-4-yl)propanamide: Gaseous Emissions N-(1-benzylpiperidin-4-yl) N-phenyl-N-(piperidin-4-yl) -N-phenylpropanamide propanamide Pd-C Catalyst Recovered Methanol Methanol Water

ML or Waste Water

Step IV: Fentanyl Base:

Gaseous Emissions : N-phenyl-N-(piperidin-4-yl) Fentanyl Base propanamide Recovered DMF Phenylethyl bromide Recovered Toluene Potassium carbonate Dimethylformamide Sodium bicarbonate Hydrochloric acid Toluene Liquor ammonia Water ML or Waste Water :

of 49



Step V: Fentanyl Citrate: Gaseous Emissions Fentanyl Base Fentanyl Citrate Citric acid Recovered Methanol Isopropyl alcohol Recovered IPA Methanol Activated carbon Water ML or Waste Water

Solid waste (Spent carbon

of 49



3.6 Raw material required along with estimated quantity likely source, marketing area of final product/s, mode of transport of raw material and finished product.

Sr. No. Description Capacity Units

Multipurpose API Plant P Nor Ephedrine Base 50 MT/year 1 PAC 175 MT/annum 2 HAH /HAS 106 MT/annum 3 Caustic Soda Lye 807 MT/annum 4 Catalyst P 99 ( fresh ) 10 MT/annum 5 Hydrogen gas - M3 73 cu.m/annum 6 Nitrogen gas 13 cu.m/annum 7 Oxalic acid 151 MT/annum 8 EDTA 9 MT/annum 9 Toluene 150 MT/annum 10 Methanol 263 MT/annum 11 Potassium Hydroxide Flakes(Caustic Potash) 120 MT/annum 12 BC-4 121 MT/annum 13 HCL CP 138 MT/annum 14 Activated Carbon 2 MT/annum P Nor Ephedrine HCL 20 MT/year 1 PAC 60 MT/annum 2 HAH 38 MT/annum 3 Caustic Soda Lye 280 MT/annum 4 Catalyst P 99 ( fresh ) 7 MT/annum 5 Hydrogen gas - M3 25 cu.m/annum 6 Nitrogen gas 4 cu.m/annum 7 Oxalic acid 44 MT/annum 8 EDTA 2 MT/annum 9 Methanol 75 MT/annum 10 Caustic Potash Flakes 42 MT/annum 11 HCl CP 26 MT/annum 12 BC-4 42 MT/annum 13 Acetone 20 MT/annum 14 Activated carbon 1 MT/annum

of 49



Sr. No. Description Capacity Units 15 Toluene 60 MT/annum D Nor pseudo Ephedrine HCL 5 MT/year 1 PAC 30 MT/annum 2 HAH 19 MT/annum 3 Caustic Soda Lye 144 MT/annum 4 Catalyst P 99 ( fresh ) 3 MT/annum 5 Sulphuric Acid 6 MT/annum 6 Hydrogen gas - M3 12 cu.m/annum 7 Nitrogen gas - M3 2 cu.m/annum 8 Acetic Anhydride 11 MT/annum 9 Oxalic acid 19 MT/annum 10 EDTA 1 MT/annum 11 Methanol 32 MT/annum 12 Potassium Hydroxide flakes (Caustic potash) 10 MT/annum 13 Toluene 18 MT/annum 14 Hydrochloric Acid 7 MT/annum 15 Activated Carbon 0 MT/annum 16 Acetone 2 MT/annum 17 IPA 20 MT/annum L Nor Ephedrine Base 25 MT/year 1 PAC 145 MT/annum 2 Caustic soda lye 693 MT/annum 3 Hydrochloric acid 29 MT/annum 4 Hydrogen Gas 60 cu.m/annum 5 Nitrogen Gas 12 cu.m/annum 6 Methanol 157 MT/annum 7 Toluene 151 MT/annum 8 P99 17 MT/annum 9 Oxalic Acid 99 MT/annum 10 EDTA 6 MT/annum 11 HAH 87 MT/annum 12 Potassium Hydroxide 42 MT/annum 13 Petroleum Ether 72 MT/annum L Nor Ephedrine HCL 50 MT/year

of 49



Sr. No. Description Capacity Units 1 PAC 175 MT/annum 2 HAH /HAS 125 MT/annum 3 Caustic Soda Lye 869 MT/annum 4 Catalyst P 99 ( fresh ) 21 MT/annum 5 Catalyst P 99 ( recovered ) 22 MT/annum 6 Hydrogen gas - M3 80 cu.m/annum 7 Nitrogen gas - M3 16 cu.m/annum 8 Oxalic acid 134 MT/annum 9 EDTA 8 MT/annum 10 Methanol 250 MT/annum 11 Potassium Hydroxide flakes (Caustic potash) 82 MT/annum 12 Toluene 155 MT/annum 13 Hydrochloric Acid 85 MT/annum 14 Activated Carbon 2 MT/annum 15 Acetone 39 MT/annum Octopamine HCL - 10MT per month 1 D M water 150 MT/annum 2 AK HCL 22.7 MT/annum 3 Methanol 80 MT/annum 4 Acetone 46.5 MT/annum 5 Activited carbon 2 MT/annum 6 Metal Catalyst 3 MT/annum 7 Hydrogen gas 2.6 MT/annum Ractopamine HCL 10 MT per month 1 RK 10.3 MT/annum 2 Octopamine HCl 10.8 MT/annum 3 Methanol 103.4 MT/annum 4 Tri-ethyl amine 6.5 MT/annum 5 Ethyl acetate 26.5 MT/annum 6 Activited carbon 0.3 MT/annum 7 Metal on carbon dry basis 0.2 MT/annum 8 Hydrochloric acid 7.5 MT/annum 9 Hydrogen gas 2.6 MT/annum 10 Sodium dithionate 0.01 MT/annum

of 49



Sr. No. Description Capacity Units POPPY STRAW PROCESSING - (To Produce Tech. Morphine, Codeine, Thebaine) Step I: Extraction of Poppy straw pellets to produce technical grade morphine, Codeine, Thebaine 1 Poppy Straw - pellets 6750 MT/annum 2 Sodium Hydroxide - 675 MT/annum 3 Sulfuric acid - 675 MT/annum 4 Ethanol - 675 MT/annum 5 n-Butanol - 675 MT/annum 6 Toluene - 675 MT/annum CODEINE PHOSPHATE FROM MORPHINE/CODEINE Step I: Conversion of Tech. morphine into codeine base; Step II: Conversion of Codeine base into Codeine Phosphate 1 Trimethyl phenyl ammonium Chloride: 60.97 MT/annum 2 Ethanol 29.12 MT/annum 3 Toluene 9.1 MT/annum 4 Sodium Hydroxide 17.29 MT/annum 5 Phosphoric acid 38.675 MT/annum 6 Activated carbon 1.82 MT/annum MORPHINE SULPHATE FROM TECH. MORPHINE Step I: Conversion of Tech. morphine into codeine base; Step II: Conversion of Codeine base into Codeine Phosphate Tech. Morphine: 1 Sulphuric acid 5.27 MT/annum 2 Ethanol 15.5 MT/annum 3 Activated carbon 0.62 MT/annum HYDROCODONE BITARTRATE FROM THEBAINE Step I: Conversion of Thebaine to Codeinone; Step II: Conversion of Codeinone into Hydrocodone Bitartrate Thebaine: 1 Hydrochloric acid: 7.8 MT/annum 2 Toluene 2.6 MT/annum 3 Ethanol 23.4 MT/annum 4 d-Tartaric acid: 10.4 MT/annum 5 Activated carbon 0.52 MT/annum

of 49



Sr. No. Description Capacity Units OXYCODONE HYDROCHLORIDE FROM THEBAINE Step I: Conversion of Thebaine to 14-Hydroxycodeinone; Step II: Conversion of 14-Hydroxycodeinone into Oxycodone Hydrochloride Thebaine: 1 Hydrogen peroxide: 12.18 MT/annum 2 Toluene 2.8 MT/annum 3 Hydrochloric acid 8.4 MT/annum 4 Formic acid: 6.16 MT/annum 5 Activated carbon 0.56 MT/annum Methadone HCl Step I: Preparation of DCN Base: 1 Diphenylacetonitrile 9.25 MT/annum 2 Dimethylamino isopropyl Chloride HCl 9.5 MT/annum 3 Toluene 37.5 MT/annum 4 Petroleum ether 3 MT/annum 5 Liquor ammonia 55 MT/annum 6 Caustic soda 7.15 MT/annum 7 HCl 17 MT/annum Step II: Preparation of Methadone HCl: 1 Magnesium metal 1.9 MT/annum 2 Toluene 30 MT/annum 3 Acetone 2.8 MT/annum 4 Diethyl ether 11.5 MT/annum 5 Caustic soda 2.75 MT/annum 6 HCl 2.75 MT/annum 7 Activated carbon 0.33 MT/annum 8 Ethyl bromide 9.35 MT/annum Fentanyl Citrate Step I: 1-Benzyl-4-anilinopiperidine: 1 1-Benzyl-4-piperidone 4 MT/annum 2 Aniline 2.2 MT/annum 3 Toluene 0.75 MT/annum 4 Methanol 1.25 MT/annum 5 Sodium borohydride 0.8 MT/annum

of 49



Sr. No. Description Capacity Units 6 HCl 2 MT/annum 7 Liquor ammonia 1.25 MT/annum Step II: N-(1-benzylpiperidin-4-yl)-N-phenylpropanamide: 1 1-Benzyl-4-anilinopiperidine 2 Propionic anhydride 3.3 MT/annum 3 Toluene 1.5 MT/annum 4 Sodium chloride 2.75 MT/annum 5 Sodium hydride 0.6 MT/annum 6 HCl 1.25 MT/annum Step III: N-phenyl-N-(piperidin-4-yl)propanamide: 1 N-(1-benzylpiperidin-4-yl)-N-phenylpropanamide 2 Methanol 0.25 MT/annum 3 Pd-C Catalyst 0 MT/annum Step IV: Fentanyl Base: 1 N-phenyl-N-(piperidin-4-yl) propanamide 2 Phenylethyl bromide 3 MT/annum 3 Dimethylformamide 8.75 MT/annum 4 Toluene 2.5 MT/annum 5 Sodium bicarbonate 1.25 MT/annum 6 Hydrochloric acid 2 MT/annum 7 Potassium carbonate 2.9 MT/annum 8 Liquor ammonia 1.75 MT/annum Step V: Fentanyl Citrate: 1 Fentanyl Base 2 Citric acid 2.25 MT/annum 3 Isopropyl alcohol 2.75 MT/annum 4 Methanol 2.5 MT/annum 5 Activated carbon 0.05 MT/annum

of 49



3.7 Resource optimization / recycling and reuse envisaged in the project, if any, should

be briefly outlined. Most of the solvents will be recycled and reused for the operation after proper purification and recovery.

of 49



3.8 Availability of water its source, Energy / power requirement and source should be

given.

Description Water Consumption kl/day

Effluent Generation kl/day Losses kl/day

Process water 500.00 467.92 32.08 Domestic water 60.00 50.00 10.00 Utility Cooling tower 150 50.00 100.00 Boiler 100 10.00 90.00 DM water 50 20.00 30.00 Gardening 20 0.00 20.00 880.00 597.92 282.08

Industrial effluent will be generated from manufacturing process, utilities and domestic uses that will be given aerobic treatment. Concentrated effluent after treatment will be evaporated through MEE, while RO permeate and MEE condensate water will be reused and/or sent to CETP. Energy / power requirement This specification along with the applicable project design data shall form the basis for developing detailed design and engineering for electrical facilities for the proposed Plant in India. Following are the assumptions: 1. Electrical incoming power supply: Normally for this type of plant having load less than 5 MVA, incoming power supply can be either 11KV OR 22KV OR 33KV depending upon location. At present we have considered 33kv incoming power supply and same will be applied from Gujarat Electricity Board. 2. Diversity factor of 0.7 is considered for plant load for deciding transformer capacity. 3. DG Back-up: 100% DG back-up is considered and hence DG rating is same that of transformer rating. 4. HVAC Load: HVAC load is considered as 1250 KW or 1500 KVA as given by HVAC department.

of 49



5. Main incoming power supply to various HVAC panels will be provided by electrical for HVAC LOAD and further distribution including supply of electrical panels and BMS by HVAC.

of 49



of 49



Transformer The new 33/0.433 KV, 2000 KVA Transformer will cater to the proposed entire plant load of Process & utility except HVAC. The new 33/0.433 KV, 1600 KVA Transformer will cater to HVAC load. Total power requirement for the proposed project will be 2000 KVA. During emergency purpose D.G. Set of 1000 KVA will be utilized. Power supply shall be full-filled by DGVCL (Dakshin Gujarat Vij Company Limited). D.G. Backup Power Since there is a possibility of breakdown of power from the Government supply grid, alternate source with 100% back up power needs to be maintained. This supply shall be sourced from captive power generation by way of Diesel generators. For entire load Emergency power supply shall be made available within a time period of less than 1 min. from the instant of failure of normal supply Diesel Generator set with AMF (Auto mains Failure), auto synchronizing and auto load sharing facilities shall be provided. DG panel shall perform the function of auto start, auto stop, auto synchronizing, and auto load sharing. Auto changeover between grid & DG power is envisaged through the breakers & PLC timers (Generator Controllers) Manual operation of Grid & DG breakers is also envisaged in case of failure of automatic system. The DGs shall be rated for continues Duty & shall be preferably of air cooled type with room acoustic enclosure designed for 75 dB at 1 M distance. The exhaust piping shall be carried out in conformation to pollution control board norms.

3.9 Quantity of wastes to be generated (liquid and solid) and scheme for their management / disposal.

DESCRIPTION EFFLUENT GENERATION KL/DAY

UNIT

Liquid Effluent 598.00 KL/DAY

Solid waste 4360.00 KG/DAY

Gases 1500.00 KG/DAY

of 49



3.10 AIR POLLUTION EMISSIONS FROM COMBUSTION OF FOSSIL FUELS FROM STATIONARY OR MOBILE SOURCES

SR.NO. STACK ATTACHED TO FUEL USED STACK

HEIGHT POLLUTION

CONTROL SYSTEM FINAL

CONCENTRATION

1. Steam Boiler (5000 Kg/Hr)

Coal 20 MT/day

35 meter Bag Filter

SPM 150 mg/Nm3 SO2 100 ppm NOX 50 ppm

2. Steam Boiler (5000 Kg/Hr)

Natural Gas 10000 Nm3/day

35 meter

Adequate stack height

SO2 100 ppm NOX 50 ppm

2. D. G. Set (1000 KVA)

HSD 180 Lit/hr

12 meter

As HSD is used as fuel, adequate stack height is provided

SPM ≤ 150 mg/nm3 SO2 ≤ 100 ppm NOX ≤ 50 ppm

PROCESS EMISSION

SR.NO. STACK ATTACHED TO STACK HEIGHT

POLLUTION CONTROL SYSTEM

FINAL CONCENTRATION

1. Process vent 08 meter Wet scrubber HCl ≤ 20mg/Nm3

3.11 SOLID WASTE GENERATION AND ITS MANAGEMENT The sources of solid wastes, generation and its management are as given in the following table.

SR. NO.

NAME OF THE WASTE

CAT NO.

TOTAL PROPOSED QUANTITY METHOD OF STORAGE AND DISPOSAL

1. Used Oil 5.1 50 Lit/Year

Collection, storage and reuse as lubricants in the machineries within the premises only or send to authorized re-processors.

2. Discarded Containers/Barrels/plastic

33.3 10 Nos./Year Collection, storage, sold to re-processors after decontamination

3. ETP Sludge/Bio 34.3 50 Collection, storage and sale as manure

of 49



SR. NO.

NAME OF THE WASTE

CAT NO.

TOTAL PROPOSED QUANTITY METHOD OF STORAGE AND DISPOSAL

Sludge MT/day or send to TSDF site.

5. Spent Carbon 28.2 0.15 MT/Day Collection, storage and send to TSDF site

6. Production Residue 28.1 0.19 MT/Day Collection, storage and send to

incineration facility

8. Biomass - 4.1 MT/Day Collection, storage and send to TSDF site or sold for manure use.

9. Fly ash - 2.4 MT/Day Collection, storage and sold to cement manufacturer or send to TSDF site.

of 49



4. SITE ANALYSIS 4.1 CONNECTIVITY 4.1.1 RAIL

The nearest railway station is Bharuch Station, which is around 39 km in east direction from the project site. 4.1.2 ROAD

The site is well connected by road network to all the key places. The major highway passing near the project site is NH-228 which is around 33 km East direction from the project site and SH-6 is adjacent to the project site in West direction. 4.1.3 AIR

The nearest airport from the project site is Baroda Airport. The distance of airport from project site is around 90 km in North direction. 4.1.4 COMMUNICATION

Proposed project site is coming within the notified industrial area of Dahej-III which is already well connected with telephone, telefax etc. all the communications facilities are well developed in the area. 4.2 TOPOGRAPHY

Topography of the land is plane. 4.3 EXISTING LAND USE PATTERN

There is no Forest, National park; Wild life sanctuary within a radius of 10 km. Details of existing land use is given in the following table:

of 49



DETAILS OF EXISTING LAND USE

SR.NO. PARTICULAR NAME & ITS DISTANCE

1. Nearest National Highway NH-228 which is around 33 km East direction

2. Nearest city Bharuch City is around 39 km in east direction

3. Nearest River Narmada at 7.5 km in south direction

4. Nearest Railway station Bharuch Station at around 39 km in east direction.

5. National park/Reserve Forest, Biosphere, etc.

None within 15 km

4.4 EXISTING SOCIAL STRUCTURE

Project site is located at a distance of around 39 km from Bharuch City. All the infrastructures are available within city and nearby village of Dahej like Schools, Hospitals & community facilities even nearby area of the project site is also developed.

of 49



5. PLANNING BRIEF Type of industries: The Active Pharmaceutical Ingredient industry is the organ by which active pharmaceutical ingredients are manufactured from raw materials through both chemical and physical means. Depending on the complexity of the molecule required, synthesis of APIs might need multi-step complex chemistry utilizing a range of processing technologies.

5.2 LAND USE PLANNING

The plant general Layout has been planned considering production facilities, auxiliary and ancillary facilities and plant utilities & services. The total plot area is 98567.05 m2. Land use shall be as build up area of buildings, storage facility, roads, greenbelt, open land etc., these kinds of facilities will be developed. 5.3 AMENTIES / FACILITIES

Adequate storage facility for chemicals, machinery spares and consumables shall be provided. A small mechanical and electrical/ instrument workshop facilities for repairs and maintenance shall be provided. Time and security offices shall be provided in the plant. To avoid fire hazard, internal fire hydrants system in all major plant unit will be provided.

of 49



6. PROPOSED INFRASTRUCTURE

6.1 INDUSTRIAL AREA

The company has already acquired land area of 98567.05 m2 in which company will establish its project. This area is notified industrial area in Dahej-III, Taluka Vagra, District Bharuch, Gujarat. 6.2 GREEN BELT

The main objective of the green belt is to provide a barrier between the source of pollution and the surrounding areas. The green belt helps to capture the fugitive emission and to attenuate the noise generated apart from improving the aesthetics. Development of green belt and other forms of greenery shall also prevent soil erosion and washing away of topsoil besides helping in stabilizing the functional ecosystem and further to make the climate more conducive and to restore water balance. The company will develop green belt area with Lawn, plants and flowers spread across about 33% of the total area i.e. 32527.12 m2. Green belt shall be developed at plant boundary, road side, around offices & buildings and Stretch of open land. The selection of tree species suitable for plantation at the industry are governed by guiding factors as stated below:

The trees should be tolerant to air pollutants present in the area The trees should be able to grow and thrive on soil of the area, be evergreen, inhabitant, having

minimum of leaf fall. The trees should be tall in peripheral curtain plantation and with large and spreading canopy in

primary and secondary attenuation zone. The trees should posses extensive foliar area to provide maximum impinging surface for

continued efficient adsorption and absorption of pollutants. The trees should be fast growing and indigenous and should maintain ecological, land and

hydrological balance of the region. It is also recommended to plant few trees, which are sensitive to air pollution, as air pollution

indicator. It is also recommended to carry out extensive plantation within premises.

Keeping in view the climatic conditions, status of soils and vegetation types in and around the project area the species shall be selected for proposed green belt development.

of 49



6.3 SOCIAL INFRASTRUCTURE

Drinking water facility, Canteen, proper sanitation, etc. will be provided to the workers working in plant. 6.4 CONNECTIVITY

As discussed earlier, proposed location of the plant is already well connected with the network of road & rail. So there is no need to construct any new road or rail for the transportation. 6.5 WASTE WATER MANGAMENT

598 KLD industrial effluents will be generated from manufacturing process, utilities and domestic uses that will be given aerobic treatment. Concentrated effluent after treatment will be evaporated through MEE. While RO permeate and MEE condensate water will be reused and/or send to CETP.

6.6 INDUSTRIAL SOLID WASTE MANAGEMENT

From the proposed project activity there shall be scope of solid/hazardous waste generation mainly from Spent/Used Oil, ETP Sludge, Process Residue & Waste, Biomass, flyash, Spent Carbon, and Discarded containers.

Land use break up

Sr. No Description Area in Sq. mt.

1 TOTAL PLOT AREA 98567.05

2 TOTAL GROUND COVERAGE AREA 20308.66

3 TOTAL BUILT UP AREA 38385.45

3.1 Area of Production 24430.71

3.2 Area of Stores & Warehouse 5650.64

3.3 Area of Office 3031.42

3.4 Area of utilities & ETP 5272.68

4 Land for green belt 32527.12

5 Parking area 9853.19

of 49



7.0 REHABILITATION AND RESETTLEMENT ( R & R ) PLAN

The project is located inside notified industrial area, which is already acquired and there is no habitat. So the project proposal does not involve any Rehabilitation & Resettlement.

of 49



8 PROJECT SCHEDULE & COST ESTIMATES 8.1 Project Execution M/s. Embio will decide on the implementation of this project beyond the pre-feasibility Study. A cost estimate for the project has been made as stated in para 8.5.

8.2 Procurement

The formal enquiry packages to be prepared as part of the Detailed Design scope of work will typically comprise of the following technical documentation;

1. Material Requisition 2. URS 3. Data Sheet 4. Engineering Specifications 5. Vendor Document Requirements

8.3 Construction Management

A constructability review will be undertaken as part of the detailed engineering study to identify significant issues and risks relating to the construction of the facility.

8.4 Project Schedule

During the detailed engineering design an integrated execution schedule for the project will be developed covering the following project phases & major activities; 1. Detailed Design 2. Procurement of Equipment & Contracts 3. Construction 4. Commissioning 5. Qualification 6. Development Runs

of 49



of 49



8.5 ESTIMATED PROJECT COST

1. Custom duties, Taxes and duties are not considered in this costing. 2. This cost is based on the Concept Study and may vary in the range of ±30%

based on actual Piping and equipment manufacturing standard considered as per American standard.

Sr. No Description Cost in lacs Rs.

1 Cost of Land and Site Development 1264.69 2 Civil of Works 11681.00 3 Cost of Process and Utility Piping & Insulation Works 2704.00 4 Cost of Utility Equipments 1457.00 5 Cost of Process Equipments 8766.21 6 Cost Process Instrumentation / Automation 775.00 7 Cost of HVAC Works 2239.27 8 Cost of Electrical Works 3832.35 9 Cost of Warehousing Equipments 553.00 10 Cost of Lab Equipments 487.00 11 Cost of IT and Allied Services 100.00 12 Cost of ETP 575.00 13 Cost of Security Fire Protection & Fire Hydrant System 817.57 14 Cost of Preoperative Expenses 500.00 Sub Total 35252.09 15 Cost of Design, Engineering and Project Management Services(@ 3.5% of Sr. No 1 to 13) 1233.82 16 Contingency (@ 10% of Sr. No. 1 to 15) 3648.591 TOTAL 40134.50

of 49



9. ANALYSIS OF PROPOSAL (FINAL RECOMMENDATIONS) It is expected the location of the site is near a reasonable sized population Centre to provide a suitably skilled workforce and the site be zoned for industrial use. The total area of the site is around expected to be around 10 hectares (1 lac square meters). It is assumed that the site is undeveloped and therefore all required facilities need to be included.

Based on this prefeasibility report, the said project at Dahej site is planned to be set up within next three years after prior statutory approvals.

This facility will provide financial and social benefits to the local people and also contribute towards the development of this area.

This prefeasibility report is being prepared for the final approval of environmental clearances for the Proposed facility at Dahej.

END OF DOCUMENT

PRE FEASIBILTY REPORT -...

Documents

Transcript of PRE FEASIBILTY REPORT -...