form-1 and pre-feasibility reportenvironmentclearance.nic.in/writereaddata/online/tor/25...d-142,...

M/s United Biotech Pvt. Ltd. New API manufacturing unit by United Biotech Pvt Ltd at Village- Bhagwanpur, Tehsil- Derabassi, District- S.A.S Nagar, State- Punjab

PRE FEASIBILITY REPORT

1

Form-1 and Pre-Feasibility Report

For

New API manufacturing unit

By

M/s United Biotech Pvt Ltd

At

Village- Bhagwanpur, Tehsil- Derabassi, District- SAS Nagar and State-Punjab

PRE-FEASIBILITY REPORT

Environment Consultant

Vardan Environet

(QCI and NABET/EIA/1619/RA 0037)

D-142, Sushant Lok-III, Sector 57

Gurgaon (Haryana)

Contact no.-9810355569

Mail ID: [email protected]

Contact No. 0124-4291036, 09899651342

mailto:[email protected]



2

Table of Contents

S.no. Chapters

Page no

1 Executive Summary

3-5

2 Introduction of the Project / Background Information

6-12

3 Project Description

13-33

4 Site Analysis

34-37

5 Planning Brief

38-48

6 Proposed Infrastructure

49-50

7 Rehabilitation & Resettlement Plan

51

8 Project Schedule & Cost Estimates

52

9 Analysis of Proposal (Final Recommendation)

53



3

1. EXECUTIVE SUMMARY

Project

M/s United Biotech Pvt. Ltd. (UBPL), one of the fastest growing Pharmaceutical

Company in India, was established in 1997. A multi-crore entity with WHO-cGMP and

ISO 9001:2008 certified state-of-the-art manufacturing facility, has strategic tie-ups with

several MNCs, apart from having one of the most exciting product pipelines in the

industry today.

United Biotech has carved out a distinct niche for itself as a pioneer company

introducing new products to the Indian Pharmaceutical Industry year after year. United

Biotech is evolving as an unique entity in the Indian pharmaceutical Industry with a

significant number of International tie ups. United Biotech currently has 6 divisions with

a combined sales force comprising of 500 people based all over the country. With

already a successful track record in the domestic market it is now aggressively gearing

up towards exports.

In the emerging pharma industry trends of this century based on new technologies

United Biotech fully recognizes that its innovative product development must be fully

complemented with cost effective therapeutic solutions to address the objectives of the

better informed medical fraternity. To achieve this, the company has harnessed all its

strengths to create a synergy continuously creating and nurturing high quality products

and technologies.

M/s United Biotech Pvt Ltd is proposing to setup a new API manufacturing unit of 500

TPA at Village- Bhagwanpur, Tehsil- Derabassi, District- SAS Nagar, State- Punjab

Location

The proposed project shall be located in 53 Bigha-0 Biswas-5 Biswasi (approx 4.4 Ha.)

and is situated at Village- Bhagwanpur, Tehsil- Derabassi, District- SAS Nagar & State-

Punjab. The land is already under the possession of project proponent.

There is no forest land is involved in this proposed project land. The geographical

location of the proposed plant lies from Latitude- 30°34'33.89"N to Latitude-

30°34'27.94"N and from Longitude- 76°53'23.93"E to Longitude- 76°53'38.55"E.

The proposed site is well connect with the road NH-22, NH-73 and SH-21 at a distance

5.3 km in NW, 9.7 km in NE and 5.6 km in NE respectively. The nearest railway station

from the project site is Ghaggar railway station at a distance 5.7 km.

The nearest major settlement is DerraBassi is at a distance of 5 km (approx). The

nearest major railway station is Ambala Railway station is at a distance of 27 km



4

(approx) in South direction. International Airport, Mohali is at a distance of 14.6 km

(approx) in NW direction.

Need for the project

The pharmaceutical contract manufacturing market is expected to hit revenues of $80.5

billion in 2019, according to a report by business intelligence provider Visiongain. A

notable trend is that pharmaceutical companies will continue to outsource more drug

production operations. For several years, API manufacturing has formed the largest

share of the pharmaceutical contract manufacturing market, driven by the increased use

of generic drugs worldwide, the rise of biologics and biosimilars, and the growth of

emerging markets such as India and China.

Project Proponent

M/s United Biotech Pvt Ltd (United Biotech) was established in 31st Jan 1997 out of the

United Group of Companies. It is a pharmaceutical company operating business

through seven divisions namely; critical care, specialty (gastroenterology & gynae),

oncology I (anticancer I), oncology II (anticancer II), hygea (antibiotics & anti-TB), copas

(cardiology) and rinon (nephrology).

Directors of M/s United Biotech Private Limited are Mr. Sanjeev Kumar, Mr. Rajiv

Kumar, Mr. Ashwani Kumar and Mrs. Kailash Devi.

Process / Technology

Active Pharmaceutical Ingredients (API) manufacturing requires that special attention

be paid to processing equipment design, hygiene and safety. The goal is to find the

most efficient processing equipment that produces the highest product quality, optimal

particle size distribution, and desired production volume, while ensuring operator safety.

Whether you are producing tablets or dispersing active ingredients, Quadro Engineering

has the experience and technical expertise to solve your API size reduction needs.

Active Pharmaceutical Ingredients (APIs) are active chemicals used as the main

ingredients in drugs and medications. APIs are added to various types of medications

for humans and animals. Since they are capable of posing serious health risks, the

federal Food and Drug Administration (FDA) has established guidelines and regulations

for the manufacturing of APIs.

Raw Material Requirement:

The Total Raw Material requirement for project estimated to be around 700 TPA.

Manpower Requirement:

During construction phase approx 50 persons will be required. Whereas it is estimated

that total 320 persons will be required for the proposed project during operation phase.



5

Indirect employment is also likely to be generated with the proposed project which will

be economically beneficial for the development.

Water requirement:

The daily requirement of water for unit is 572 KLD. About 200 KLD water will be

required in process & make up water required for cooling purpose will be 100 KLD.

Water required for boiler will be 160 KLD and for domestic purpose 30 KLD. Which will

be sourced from own bore-well for which the permission will be taken from CGWB.

Effluent Generation:

The Company proposes to Install a Zero Discharge ETP Plant comprising of Primary

Treatment, Multi Effect Evaporator, Biological Treatment, Tertiary Treatment, Reverse

Osmosis so that there will be no discharge out of premises.

Solid & Hazardous Waste:

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

intermediates are stored securely at hazardous waste storage area and sent TSDF, to

incineration and to recyclers as per the Authorization under Hazardous Waste Rules.

Capital Cost of the project:

The total cost for the proposed project estimated to be 100 Crores (approx). Which

include the proposed investment in plant and machinery, investment in Building

construction, investment in site Development & Fixed Assets.

---------------------



6

2. INTRODUCTION OF THE PROJECT / BACKGROUND

INFORMATION

(i) Introduction

M/s United Biotech Pvt Ltd (United Biotech) was established in 1997 out of the United

Group of Companies. It is a pharmaceutical company operating business through seven

divisions namely; critical care, specialty (gastroenterology & gynae), oncology I

(anticancer I), oncology II (anticancer II), hygea (antibiotics & anti-TB), copas

(cardiology) and rinon (nephrology). The company caters to surgeons, orthopedicians,

gynecologists, gastroenterologists, oncologists, cardiologists, nephrologists,

paediatricians, pulmonologist, urologist and physicians.

It operates a manufacturing plant in Baddi, HP, which manufactures various dosage

forms including; dry powder injectables, lyophilized injectables, liquid injectables in vials

and ampoules, pfs, tablets, capsules, ointments, syrups, eye and ear drops. It has pan

India presence with a comprehensive network of 18 C&F agents & 1,200 stockists.

Globally, the company has presence in more than 55 countries. Some of its brands

include; Forzid, Menem, Tazin, Univir, Glugon, Vonaz, Kezone, Clavox, Dalpin, Levotec,

Roxitec, Gavir and Lenid.

Structure of Indian Pharmaceutical Industry

The pharmaceutical industry in India mainly comprises four segments:

Formulations – These are the final products of the drug manufacturing process and

they can be in the form of tablets, capsules, injectables, syrups, gel, paste, powder,

ointment etc. These can be consumed directly by patients.



7

API/Bulk drugs (intermediates) – Active Pharmaceutical Ingredients (API) is the

primary active ingredient that is manufactured in the initial stage of pharmaceutical and

drug production. It is the ingredient that results in desired therapeutic effect in the

human body. Bulk drugs are active chemical substances and are used in the

manufacturing of pharmaceutical and drug formulations. API/bulk drugs can be

considered as inputs that are used in making of formulations.

CRAMS – Contract Research and Manufacturing Services (CRAMS) is an outsourcing

process that implies outsourcing of research and product manufacturing services at a

lower cost. About USD 55 billion is the expected sales gain to generics drugs on

account of branded drugs going off patent during 2017-19. After these patents lose

coverage, there will be a requirement to manufacture these drugs in a cost-effective

manner to keep them price competitive. This, in turn, will create an opportunity for India

that is one of the low-cost manufacturing centers in the world.

Biosimilars - Biosimilars can be referred as medicines that are generic version of

biological products. Biosimilars can be manufactured by new companies only after the

patent expiry of the original biological product. A biological product is a medical product

produced using biotechnology. The immense potential of India in biosimilars market can

be supported by the fact that India is equipped with sophisticated Research &

Development facilities meeting international standards, cost effective labor.

Position of Indian Pharmaceutical Industry

The Indian pharmaceutical industry holds a strong position in terms of production

volumes in the global pharma market as the country contributes around 10% of the

world production volumes and in terms of value, India holds a share of around 2.4%

globally. The Indian pharmaceutical industry is largely dominated by generics drugs as

the industry earns around 70% of its revenues from the same. This can also be implied

from the fact that India holds 13th position in terms of production value in spite of

holding third position in terms of production volume globally. IPI registered revenue of

around USD 33 billion in 2016. Exports form a major part of the industry‟s turnover and

over 50% of the sales comes from exports. Lower cost of production coupled by

efficient scientific and technical skills of human resources are the prime reasons for

growth in exports from India. The cost of drugs manufactured in India is one of the

lowest in the world.

Relative Comparison of Major Cost Advantage in India

Cost in developed countries 100%

Production cost in India 50%

R and D cost in India 12.50%

Clinical Trial cost in India 10%

According to IBEF, the cost of production in India is approximately 60% lower compared to US and almost half when compared to Europe.



8

(ii) Identification of Project & Project Proponent

Project

M/s United Biotech Pvt Ltd is proposing to setup a new 500TPA of API manufacturing

unit at Village- Bhagwanpur, Tehsil- Derabassi, District- Mohali, State- Punjab.

Project Proponent

The company and directors profile is mentioned below

NAME AND ADDRESS OF THE COMPANY

M/s UNITED BIOTECH (P) LIMITED Registered office

FC/B-1 (Extn) Mohan Co-operative United House

Industrial Estate, Mathura Road E-142 Saket

New Delhi 110044 New Delhi 110017

Ph. 9816677739, 9816677745

Fax: 011-66607096

E-mail – [email protected]

Constitution of the company : Private Limited

Name & Address of Directors/Promoters : Mr. Rajiv Kumar

E-142 Saket New Delhi

1). Mr. Rajiv Kumar, Managing Director

Date of Birth : 9th April,1963

Qualification : M.Pharma in 1987

Date of Appointment : 31.01.1997

2). Mr. Sanjeev Kumar Director

Date of Birth : 2nd June 1966

Qualification : B. Pharma


3). Mr. Ashwani Kumar Director

Date of Birth : 26 Sep1966

Qualification : B. Pharma


mailto:[email protected]



9

Professional Experience

a) 1987-1995: Worked in Pharma Management Team in various capacities with Mc

Kinsey(India).

b) 1995-1997: As Vice President (Marketing-India), Essetti Farmaceutici SPA Italy.

c) 1997-2012: Managing director & Chief Executive Officer in United Biotech (P) Limited

4). Mrs. Kailash Devi, Director

Date of Birth : 5th Jan, 1937

Qualification : B.Sc. Delhi University, 1955


Professional Experience

a). 1958-1994: Retired as a Principal from a public high School

b). 1995-1997: Officer on special Duty, Batra Hospital Pharmacy

c). 1997 to till date: Director (Logistics & Distribution), United Biotech (P) Limited

(iii) Brief description of nature of project:

As per EIA Notification dated 14th September, 2006, as amended on 25 June 2014, the

project falls under activity „5(f)‟ and the presence of interstate boundary of Haryana and

Punjab within 5km from the project site in East direction and location of the land outside

the industrial area makes the general condition applicable on the project which makes it

category ‘A’ project.

(iv) Need for the Project and its importance to the country and or region.

Market Survey-

After operating in a controlled environment for the last few decades, the industry finds

itself in a state of heady freedom, as one by one, its shackles get removed. The Drug

Price Control Order (DPCO) relaxation, the drug policy amendments, and factors

leading the pharmaceutical industry into „revolutionary‟ times compared to what it used

to be earlier. As the countdown for the introduction of product patent begins, the

industry has starting preparing itself for a major shakeout. The shakeout is imminent,

and inescapable. In fact, the cataclysm could be so conclusive, that it could catch

thousand of players totally unprepared, and leave them condemned to a rapid

extinction.

The pharmaceutical industry is quite applied, often referred to as a “life line” industry.

That is why most developing nations, which also have to contend with every large

population, have necessarily to pay heed to a policy for the pharmaceutical sector which



10

find acceptance both with entrepreneurs as well as common citizens who have to pay

price for nursing their sick and ailing kith and ken.

Today the pharmaceutical industry is in the front rank of India‟s science-based industry,

with wide ranging capabilities in the complex field of drug manufacturing and

technology. From simple headache pills to sophisticated antibiotics and complex cardiac

compounds, almost every type of medicine is now made in India.

Supply – Demand Gap

The pharma industry in India is highly fragmented, both in terms of number of

manufacturers as well as the variety of products. As per the estimates of the

Organization of Pharmaceutical Producers of India (OPPI), the number of licensed

manufacturing units in India has increased.

As far as the products concerned, the pharmaceutical industry can be divided into Bulk

drugs and Formulations. Bulk drug are the Chemicals, which are used to prepare the

formulations, which are the final products for consumption. The main pharma industry is

quite vast with many product groups within. The main product group include Vitamins,

Analgesics, Antacids, Antibiotics, Antidiabetic, Antibacterial, etc.

(v) Imports Vrs. Indigenous Production

Company is making its Raw Material / Packing material procurement from the domestic

market in big quantities more than as compared to its Import Purchases.

Since Company is also doing Exports and hence its majority of Export supplies are

against the schemes and benefits allowed /extended by the Hon‟ble Ministry of

Commerce / Hon‟ble Ministry of Finance of Government of India, to the Exporters. So as

to promote the Export business in India. Thus, Company in this manner and under

statutory provisions and rules, is also utilizing the Import benefit policies allowed/

extended & allowed by the Govt. of India to the Exporters.

(vi) Export possibility

Of the total exports of USD 16.8 billion during the year 2016-17, majority of the exports,

accounting for 40.6% were to the American continent followed by 19.7% to Europe,

19.1% to Africa and 18.8% within Asia.

The pharma export volumes from India to US however are expected to rise. This will be

backed by about USD 55 billion expected sales gain to generics drugs on account of

branded drugs going off patent during 2017-19 which will create an opportunity for

CRAMS segment. We expect growth rate for CRAMS to be higher compared to average



11

growth rate of the industry. These factors are likely to support pharma exports from

India.

Continent-wise Exports of Drugs & Pharmaceuticals in 2016-17 (USD billion)

(vii) Domestic/Export Market

Domestic Market: As per the Union Budget 2017-18, the government wants to ensure

the availability of drugs at reasonable prices and so it may continue with the drug price

control regime which can have an impact on prices. The domestic demand for

formulations however is expected to grow steadily backed by growth in presence of

chronic diseases, increasing per capita income, improvement in access to health care

facilities and penetration of health of insurance.

Export Market: Among the countries, United States of America is the primary export

destination for India. Exports to USA have been on a rise since more than a decade.

The exports are mainly driven by the cost advantage that India has. The share of

exports to USA in total drugs & pharma exports from India which was 25.4% in 2012-13

increased to 33.1% in 2016-17. For other countries like UK, South Africa, Nigeria,

Russia, Brazil, Germany, Australia, the share of each of these countries in total drugs &

pharma exports remained in the range of 1.4%-3.3% in 2016-17.

In 2012-13, exports to USA grew by 14.2% y-o-y to USD 3.7 billion and increased in

single digit in each of the following two years. In 2015-16, exports to USA surged by

27.8% to USD 5.5 billion on a y-o-y basis. However, the export scenario to USA

weakened and it grew by a marginal 1.3% to USD 5.6 billion in 2016-17. The prime

reasons for the weak exports were price erosion in the generic market in USA due to

consolidation among customers i.e. the distribution channels, increase in competition,

absence of blockbuster drugs going off patent and regulatory issues faced by Indian

Pharma companies. In the financial year 2016-17, the profit margins of the industry



12

remained almost at the year ago level. The industry‟s operating margin contracted by 70

basis points to 25.6% and the net margin eroded by 20 basis points to 14.5% on a y-o-y

basis.

The Indian pharmaceutical industry is likely to face competition from other countries to

get ANDA approval. Apart from this, the Indian pharma companies will continue to

witness pricing pressure in the US generics market due to consolidation of distribution

channels and increase in competition.

Both the Domestic & Export supplies of the company will indirectly contribute to the

growth of our nation.

(viii) Employment Generation (Direct and indirect)

During construction phase approx 50 persons will be required. Whereas it is estimated

that total 320 persons will be required for the proposed project during operation phase.

Indirect employment is also likely to be generated with the proposed project which will

be economically beneficial for the development.

(ix) Goods and Services Tax (GST) and Pharma Industry

Post implementation of GST, logistics cost for the industry is likely to reduce. Under the

pre-GST regime, the companies had to pay 2% Central Sales Tax (CST) on inter-state

sales.

To avoid this cost, the companies maintain warehouses in each state. Now with the

implementation of GST, the CST will get subsumed with GST, this will create an option

for the companies where they can prefer not to have warehouses in each state thus

reducing their dependency on CFA.

The companies can therefore set up warehouses keeping in mind the logistics benefits

rather than considering CST. With the implementation of GST, most medicines fall

under the category of 12% whereas essential drugs including insulin fall under the

category of 5%. In the pre-GST regime, the formulations including excise duty and VAT

were taxed at around 9% and the tax on inputs of bulk drugs was 12.5%. We believe

that with implementation of GST, there will be no major change in the prices of

medicines and we expect that the government will continue to keep a check on the

prices of controlled as well as noncontrolled drugs.

--------------------



13

3. PROJECT DESCRIPTION

(i) Type of Project including interlinked and interdependent projects, if any

The proposed integrated facility will produce 500 TPA of API, which can be used in the

bulk drug manufacturing.

The project will be equipped with fully diversified processing facilities. The number of

working days for the proposed project will be 330 days. The Plant will be operated 6 days

in a week along with effective utilization of the resources.

(ii) Location (Map showing general location, specific location, and project

boundary and project site layout) with coordinates




There is no forest land is involved in this proposed project land. The geographical

location of the proposed plant lies from Latitude- 30°34'33.89"N to Latitude-

30°34'27.94"N and from Longitude- 76°53'23.93"E to Longitude- 76°53'38.55"E.




The nearest settlement is DerraBassi is at a distance of 5 km (approx). The nearest

major railway station is Ambala Railway station is at a distance of 27 km (approx) in

South direction. Lalru and Dappar Railway stations can also be used to avail regional

trains. International Airport, Mohali is at a distance of 14.6 km (approx) in NW direction

Project site falls in survey of India Toposheet no. H43K14& H43K15. Location map of

the Project site is presented in Figure 3.

The presence of interstate boundary of Haryana and Punjab within 5km from the project

site in East direction and the location of the proposed project land outside the notified

industrial area makes the general condition applicable on the project which makes it

category „A‟ project. So the Proposed project will be appraised at MOEF&CC.



14

Figure 1: Location Map



15

Figure 2: Location plan and road connectivity



16

Figure 3: Key Plan showing 10 km radius study area



17

Figure:4 Layout Plan of the Project



18

(iii) Details of alternate sites Considered and the basis of selecting the proposed

site, particularly the environment consideration gone into should be

highlighted.

No alternate sites have been examined for the proposed project as the project shall be

setup on the purchased land which is issued by Government of Punjab, Department of

Industries in Free Enterprise Zone (FEZ) under Punjab Industrial Incentive Rules notified

vide No.28/35/78/51 EI-79/1464 dated 21st March, 1979 and vide NO. 3/4/87-3IB1/311

dated 09th Jan, 1990 and as amended from time to time shall be limited to the

permissible industrial use zones only i.e. Free Enterprise Zone in the Chandigarh

Periphery and the Industrial Zone in Dera Bassi Ring Town Master Plan.

(iv) Size and Magnitude of Operation

M/s United Biotech Private Limited is proposing to setup a new API manufacturing unit

with the capacity of production of 500 TPA at Village- Bhagwanpur, Tehsil- Derabassi,

District- S.A.S Nagar, and State- Punjab. The estimated project cost is about 100 Crores.

(v) Project description with process details: (a schematic diagram/flowchart

layout, components of the project)

Active Pharmaceutical Ingredients (APIs) are active chemicals used as the main

ingredients in drugs and medications. APIs are added to various types of medications for

humans and animals. Since they are capable of posing serious health risks, the federal

Food and Drug Administration (FDA) has established guidelines and regulations for the

manufacturing of APIs.

Care should be taken in how you set up a manufacturing process. Constant vigilance is

required to ensure the success. The failure of one step, or the deviation of another could

be the difference between product defects, or a manufacturing recall. The development

of the process has already been achieved, but there are obstacles; from the beginning of

production, to packaging at the end, that can inhibit your efforts to manufacture a

product, and be an asset to your business.

Forming a manufacturing process requires an understanding of the purpose of the

process, design of the part or parts being processed, equipment requirements and labor

requirements. Facility alterations, purchase lead times for equipment, training and data

input to manufacturing resource planning software systems supporting the process must

be determined. A plan and budget must be approved and the project must be staffed and

managed.

List of proposed products of Sterile and Non-Sterile API is mentioned below.



19

S.No. Product Production (TPA) 1 Penicillin API 352

2 Cephalosporin API 35

3 Oncology API 6.3

4 Penems API 34.5 5 Macrolide 20.5

6 Hormones 40.1

7 Generals 6.3

Total 494

Detailed production details are given in table below

S.No. BLOCK PRODUCT Quantity (IN KGs)/ Annum

1 Beta Lactam

(Sterile)

Ticarcillin monosodium 50,000

Amoxicillin 200,000

Potassium Cluvunate 2,000

Sulbactam 50,000

Ticarcillin monosodium 50,000

352,000

2 Cephalosporin

Sterile / lyophilized Product

Cefazoline 3,000

Ceftazidime 2,000

Cefotaxime Sodium 2,000

Ceftriaxone Sodium 10,000

Cefoperazone 2,000

Cefrone 2,000

21,000

NON-STERILE

Cefuroxime axetil 10,000

Cefixime trihydrate 2,000

Cefepime Hydrochloride 2,000

14,000

3 Penems

STERILE

Meropenem trihydrate 10,000

Imipenem Monohydrate 2,000

Cilastatin sodium 2,000

Sodium carbonate 18,000

Sodium bicarbonate 1,000

Doripenem monohydrate 200

33,200



20


NON-STERILE

Doripenem monohydrate 275

Ertapenem sodium 1,000

1,275

4 Macrolide

NON-STERILE

Clindamycin HCL 10,000

Clarithromycin 10,000

Ketamine 500

20,500

5 Hormones

STERILE

Methyl Prednisolone Sodium Succinate 10

Hydro Cortisone Sod.Succinate 10

Noradrenaline 100

Vasopressin 1

FSH 1

NON-STERILE

L - Irnatarin L - Aspartame 20,000

Cal. polystyrene Sulphonate 20,000

40,000

6 Oncology Block -

I (Cyto)


Ifosamide 2,000

Dacarbazine 200

Procarbazine 1,000

Paclitaxel 200

Docetaxel 150

Gemcitabine 500

Cisplatin 100

Carboplatin 300

Gefitinib 500

Oxyplatin 50

Irotecan 5

5,005

NON-STERILE

Capecitabine 3,000

Cyclophosphamide 2,000

Methotrexate 200

Anastrozole 20



21


Mercaptopurine 1,000

Estramustine 20

6,240

7 Oncology Block

II

Megesterol acetate 2

Letrozole 50

Imatinib 2

54

8 General Block


Propofol 200

Midazolam 100

Succinyl choline chloride 100

Isoflurane 100

Vecuronium bromide 50

Fentanyl 50

Ganciclovir 200

Valacyclovir 200

Tirofiban 20

Enoxaparin 500

Eptifibatide 50

1570

Non-Sterile Product

Tigecycline 100

Deferasirox 100

Citicoline 500

Voriconazole 1,000

azathioprine 2,000

Cyclosporine 1,000

4,700

Total Material Generated(Approx.) 500,000

Process Flow

The manufacturing process can be summarized in the following steps.



22

(A). Sterile/ Lyophilization Process (B). Sterile/ Crystalline API Process

Figure:5 Process flow diagram

(vi) Raw material required along with estimated quantity, likely source,

marketing area of final products, mode of transport of raw material and

Finished products.

Total Raw Material consumption is estimated to be 700 TPA for the product 500 TPA of

API. The details of the raw material required for the proposed production of 500 TPA od

API is mentioned below.



23

Raw Materials

Tazobactam

Acetic acid Meropenem

Hydrogen Iodide Activated carbon

Ticarcillin Acetone

Amoxicillin Sodium bi carbonate

Sodium Hydroxide CO2 cylinder

Ethyl Sodium Hexanoate Cilastatin Sterile

Clavulanic Acid Cilastatin acid

Sulbactam

Cephazolin Imipenem Monohydrate Ethyl Acetate

Ertapenem sodium Sulphuric Acid Acetic Acid

Ertapenem side chain MDC

Methyl Enol Phosphate

Doripenem Cefazoline

Doripenem side chain Cefixime

Imipenem Activated Ester

Diphenyl Chlorophosphate Ceftazidime

Dimethyl Amino Pyridine Cefotaxime Sodium

Di Isopropyl Ethylamine Ceftriaxone Sodium

N-methyl pyrollidone Cefuroxime axetil

Cysteamine Hydrochloride Acetoxy ethyl bromide

Bicycloketone Cefoperazone

Diiso propyl Ethylamine Cefepime

N-Methyl Morpholine Cefrone

Iso Propyl Alcohol Propofol

2.5% Palladium on carbon Midazolam

Vecuronium bromide Succinyl choline chloride

Thiopentonate sodium Isoflurane

Fentanyl Deferasirox

Eptifibatide Cycloserine

Tirofibara Capreomycin

Benzyl formimidate HCL Ethionamide

Sodium Hydrosulphite Dimethyl formamide

Imipenem Potassium hydrogen orthophosphate

Gemcitabine Estramustine

2-3-di-O-Acetyl- 5- deoxy - 5- florocytidine Bis- chloro Ethyl Amine

N - Pentyl chloro formate Phosgene

Pyridine Estradiol



24

Capecitabine Gefitinib

5-methyl tetrahydrofuran-2,3,4-triyl triacetate

7-methoxy-6-(3-morphalino propyl) quinazoline- 4 (3H) -one

5 - fluorocytosine Thionyl chloride

Hexamethyl disaline 3-chloro-4-fluoroaniline

Tetra methyl silyl chloride Imatinib

Stannic chloride 4-methyl-N3-(5-pyridin-3yl pyrimidine-2-yl) benzene-1,3-diamine

n - pentyl chloroformate 4-(4-methyl-piperazin-1-yl-ethyl) benzoic acid dihydrochloride

n - Heptane Hydroxy benzotriazole

Carboplatin Methane sulphonic acid

Potassium tetrachloro platinate Cyclophosphamide

potassium iodide Bis - 2 chloro ethyl amine hydro chloride

Ammonia Phosphoryl Chloride

Silver nitrate 3 Amino Propanol

Cyclobutane dicarboxylic acid

Anastrozole

Cisplatin α, α, α, α Tetra methyl - 5 - (methyl)-1,3-benzenedi –acetonitrile

Potassium tetrachloro platinate N-Bromosuccinimide

potassium chloride 1,2,4 Triazole

Ammonium hydroxide Potassium Carbonate

Silver nitrate Cyclobutane dicarboxylic acid Ifosfamide

(R) - 3 -(2 - chloro ethyl -2(2 chloro ethyl) ino )1-3- 2 oxazaphosphorinane-2-oxide

Dacarbazine Sodium Borohydride

4-amino -5 imidazole carboxide HCL Sodium nitrate Her-s imidazole carboxamide Docetaxel

diethyl amine Phenyl iso serine methyl ester formate

Butyl Lithium

Paclitaxel Phenyl iso - serine

10 - DAB Hydrogen Fluoride

Butyl Lithium iso - butyl Aldehyde

Phenyl iso - serine di - tertiary butyl dicarbonate

Hydrogen Fluoride Lithium Hydroxide

10 - De Acetyl Baccatin III

OXALIPLATIN Di - nitro benzyl chloride

Potassium tetra chloroplatinate DMAP



25

Trans - 1,2- diamino Cyclohexane Di Ethyl Ether

Silver oxide Oxalic acid Acetonitrile

HBr

IRINOTECAN HCl TRIHYDRATE Activated Carbon

R-3-7-Ethyl -10 - hydroxy camptothecin Hydrogen Gas

R-1 -chlorocarbonyl -4-piperidino Piperidine Base

Raney Nickel

Tri Sodium Phosehothioate

Ethyl Amine

2,2,6,6-tetra methyl-1-piperidine oxide Methanol

lodo benzene diacetate Acetone

Sodium thio sulphate 5-Azacytosine

(7-bromoheptyl) - (4.4,5,5,5-pentafluoropentyl) sulfane HMDS

Tri phenyl phosphine Ammonium Sulphate

Palladium Carbon 1,2,3,5-tetra-o-acetyl-~-D-: ribofuranose

Aluminium trichloride Tins-triflate

Thiourea Sodium Carbonate

n-Butyl lithium Oichloromethane

Dlchlorornethane 1-Chloro 2,4 Di Nitro Benzene

4-ethyl-10-hydroxy-camptothcin NaHCo3

1- chloro-carbonyl-4-piperidino piperidine base Sodium Sulphate

2,4,5,6- Tetra Amino Pyridine 2-Chloro Ethanol

Formamide Potassium Carbonate

Ammonium hydroxide Di Iso Propyl Ethyl Amine

Sodium bi carbonate IPA

2,6 - diacetamido purine Ethyl Acetate

Methanolic sodium -methoxide MDC

Fluoroboric Acid Methyl Amine

Ethanolic Ammonia Heptane

Boron tri fluoride Iso Butyl Boronie Acid

Sodium Carbonate Pinanediol

Iso Vanillin Zinc Chloride

3- Chloro phenyl rnorpholine N-Hexyl Lithium

Oxylyl chloride Di Iso Propyl Amine

3-Chloro-4-f1uoroaniline Tri Fluoro Acetic Acid

Ribofuranose Compound L-Phenyl Alanine

Vitride Pyrazine Carboxylic acid



26

TMSC N-Hydroxy.Succinamide

TMS Triflate Di Cyclohexyl Carbodiimide

Ethylene Dichloride N-Methyl Morpholine

Isopropyl Ether 2-Chloro-4,6-dimethoxy-1,3,5-triazine

Ortho Toluidine Sodium hydroxide

Cyanamide N-Hydroxy.Succinamide

Cinnarnvl Ketone Hydrochloric Acid

NaOH Flakes Dicyclohexyl dicarboximide

n-Butanol Di isopropyl ethylamine

3 - Chloro - 4 - (3-fluoro - benzyl oxy) nitrobenzene Intermediate-I

Iron Powder Intermediate-II

4 - chloro - 6 - iodo - quinazoline Di Iso-Propyl Ether

5 - formyl - 2 - fluoro - bromic acid DMF

Palladium acetate Tetra hydro Furan (THF

Methyl sulfonyl ethyl amine Hcl N-Heptane

Di isopropyl ethyl amine 1, 4Butanediol

Sodium tri acetoxy boro hydride Methane Sulfonyl Chloride

Isopropanol Pyridine

Methyl-2-bromormethyJ-3-nitrobenzoate Ether

L-N-CBZ-Glutamine D-Ribose

Potassium t-butoxide Sulfuric Acid

MTBE Stannous Chloride

4-Bromo Methyl Benzo nitrile 5-Fluoro cytosine

4-Amino1,2,4triazole Ammonia Solution

Potassium tertiary Butoxide Glacial acetic acid

Fluoro Benzo nitrile Acetic Anhydride

Cyclohexyl iso cyanate PTSC

isopropyl Alcohol n-Pentyl chloroformate

Sulphuric Acid Acetic Acid

Potassium Phthalamide Sodium Chloride

Ethyl cvano acetate Isopropyl Alcohol

Sodium Metal Potassium tetra chloro platinate

Urea Potassium Iodide

Sodium dithionate Ammonia

Phosphoryl chloride Silver Oxide

Ethyl benzene CBDCA

2, 4, 5, 6 -Tetra amino - pyrimidine sulphate 3-Bis(2-Chloroethyl)-1-Urea

Sodium Bisulphate Methylene Chloride



27

1,1-Dichloro acetone Sodium Nitrite

Caustic Lye Carbon Oi Sulphide

Bromine AICI3

Dibenzoyl Peroxide Acetamide

Barium salt dehydrate of P-(N-methyl)-amino benzyl-L Glutamic Acid Succinic Anhydride

N-methyl pyrrolidone Na2Co3

Potassium tetra chloro palatinate Hyflo

1,2- diamino cyclo hexane Ethylene Oxide

Potassium Oxalate Tri Ethylene Glycol

LI HMDS KOH

TROC - CI Hydrazine Hydrate

Oxazoline Carboxylic Acid PoCI3

DMAP Petroleum Ether

Di cyclocarbodimide Toluene

Trifluoro acetic acid Liquid Ammonia

Sodium Acetate Silver Nitrate

Triethyl Amine Potassium Chloride

4 - (Dimethylarginine) - pyridine 5-Amino Imidazole-Carbonamide Hydrochloride

M - methyl - 2 - pyrrolidone NaNO2

Methylene dichloride Di methyl amine

Para Tolnic Acid 2-Deoxy ribose

Benzoyl peroxide Acetyl Chloride

N - Bromosuccinamide Tins triflate

Sodium bisulphate Methanolic Ammonia

Methyl hydrazine Dichloromethane

Picolinic Acid Acetonitrile

Thionyl Chloride 3-Chloro-2-amino-benzoicAcid

4- Amino Phenol Lithium hydroxide monohydrate

4- Chloro - 3(trifluoro - methyl) - phenyl iso cyanide Lithium Aluminium Chloride

Potassium tetra butoxide Ammonium Chloride

T - butyl acetoacetate Chloro Acetyl Chloride

Zn powder 2-Hydroxyethyl piperazine

Phosphorus oxychloride Ethyl di isopropyl amine

Morpholine Formic Acid

Diethyl ether 1-trityl-3- ((di methyl-amino) methylene)

3-Chloro-Propionyl-chloride Tri-Methyl acetyl chloride

NaBH4 4,6-dochloro-2-methyl-Pvrimidine

Triethyl amine Lithium hydroxide



28

Dimethyl amine pyridine NaOBu-t

Methane sulphonyl chloride Di chloro Methane

3,4-Dimethoxy Benzaldehyde Hexane

N, N-Dimethyl formamide Ethanol

Hydroxyl Amine Hydrochloride (2R,3S)-3-Phenyl iso serine-methyl ester formate

Nitric Acid (70% Isobutyl aldehyde

Ferric Chloride Magnesium sulphate

Formic Acid 2-lodo ethyl methyl ether

Hydrogen Bromide IPAHCI

Oxalyl Chloride Copper bromide

Ethynyl Aniline Tri methyl ortho formate

(vii) Resources optimization/recycling and reuse envisaged in the project, if any, should be briefly outlined.

M/s. United biotech Pvt Ltd will optimize utilization of resources including Land, Fuel, Water and Electricity.

(viii) Availability of Water its source, Energy/Power requirement and source

Water Requirement

The daily requirement of water for unit is 572 KLD. About 200 KLD water will be required in process & make up water required for cooling purpose will be 100 KLD. Water required for boiler will be 160 KLD and for domestic purpose 30 KLD. Which will be sourced from own bore-well for which the permission will be taken from CGWB.

Water Flow Diagram is given below



29

(ix) Power Requirement

Maximum power requirement for the plant is estimated to be 2000 KVA. The power will

be supplied from PSTCL (Punjab State Transmission Corporation Limited) 4 D.G. sets

each of capacity 500 KVA is also proposed as the backup power supply

(x) Raw Material Requirement

The Total Raw Material requirement for project will be around 700 TPA.

(xi) Quantity of waste to be generated (Liquid and solid) and scheme for their

management.

Process waste

The process of manufacturing Sterile & non-sterile API require minimal consumption of water for cleaning the Equipments and Canisters. The requirement of water by the factory for sanitization and cleaning shall be 25 kilo liters per day. On the other hand, in API blocks all the reactions are in Organic solvent.

A separate Zero discharge ETP will take care of the effluent the detail report of ETP

plant is attached with t: he reports. Solid waste of ETP will be dispose off in Incinerator.

LIQUID WASTE

Effluent generated from manufacturing process will be treated in Effluent treatment cum

Sewage treatment plant. Details of waste water are given in Table

S. No Purpose Waste Water Generation in KLD

Disposal Details

1 Process 220 ETP with Evaporator

And RO System and

the permeate is

reused in cooling

tower

2 Reactor & Floor Washing 40

3 Boiler Blow Down 40

4 Cooling Tower Blow Down 30

5 Scrubbing system 25

6 DM Plant 20

7 Domestic 25

Total 400

INDUSTRIAL WASTE MANAGEMENT:

The Company proposes to Install a Zero Discharge ETP Plant comprising of Primary Treatment, Multi Effect Evaporator, Biological Treatment, Tertiary Treatment, Reverse



30

Osmosis so that there will be no discharge out of premises. The details of treatment sequence are given below: PRELIMINARY TREATMENT (BAR SCREEN, OIL & GREASE TRAP and EQUALISATION TANK) The preliminary treatment begins at effluent source by installing bar screen in drains to

arrest polythene bags etc. at the source and prevents their ingress to the system. In the

first tank, oil and grease settle down and in the equalization tank, the effluent is

neutralized using alkali/acid.

TREATMENT – 1 (FLASH MIXER and PRIMARY CLARIFIER):

From equalization tank, effluent is transferred to Flash mixer where poly-electrolyte is

added and is sent to Primary Clarifier where excess solids settle out and are removed

under gravity by sludge drying bed. Clarified effluent is passed on to for secondary

treatment in the MEE then aeration tank.

TREATMENT – 2 (EVAPORATOR):

After the primary treatment, effluent is passed through Evaporator process to reduce

BOD and COD. High TDS Effluent from primary clarifier enters in the

Evaporator process here condensation of effluent take place. Condensate effluent with

low TDS sent to the aeration tank and left residues disposed of at TSDF site.

TREATMENT – 3 (AERATION TANK):

After primary treatment of effluent, effluent is sent to Aeration Tanks for BOD removal in

presence of Oxygen and Nutrients. Aeration is provided in Aeration Tanks to get the

required COD and BOD of the effluent.

TREATMENT – 4 (SECONDARY CLARIFIER):

Effluent with required COD and BOD is sent to the secondary clarifier

where excess microorganism colonies settle out and return to the aerobic reactor and

the effluent is drained to sludge drying beds.

TREATMENT – 5 (SLUDGE DRYING BED and FILTERATE SUMP):

Sludge Drying Beds has been provided to collect sludge from PRIMARY CLARIFIER /

SECONDARY CLARIFIER and the filtrated effluent from sludge drying bed is collected in

Filtrate Sump which is again sent to Equalization tank for re - treatment. The dried sludge

from sludge drying bed of PRIMARY CLARIFIER is given to authorize recycler and



31

sludge recovered from secondary clarifier is used as manure in fermi-irrigation since it is

a biomass and Non-Hazardous in nature.

TREATMENT – 6 (DMF SUMP, SAND FILTER and CARBON FILTER):

DMF sump will receive treated effluent from secondary section and hold it for pumping to

filters. The high-pressure pumps are used to feed Sand Filter and Carbon Filter. Filtered

effluent is sent to treated water tank from there the treated water is used in ferti -

irrigation in plant. A schematic diagram of effluent cum STP is given in fig.

TREATMENT – 7 DMF SUMP, (REVERSE OSMOSIS):

Treated effluent will be passed through Reverse Osmosis Plant for recycling of Treated

effluent. The permeate from RO will be reused in the Plant for less stringent applications

and Reject from RO will be sent back to Evaporator. The Conc. from Evaporator will be

sent to Common Hazard Waste Disposal site and condensate from Evaporator will be

treated, thus no effluent discharge.

Schematic Diagram Effluent Treatment Plant



32

SOLID WASTE

The Company proposes to Install a Zero Discharge ETP Plant comprising of Primary

Treatment, Multi Effect Evaporator, Biological Treatment, Tertiary Treatment, Reverse

Osmosis so that there will be no discharge out of premises. The details of treatment

sequence are given below.

Treatment flow for effluent as per segregation

Effluent Type --------Treatment Flow

HTDS/HCOD------ Collection----- Equalization & neutralization

Stripper ----MEE----- TSDF

HTDS: Collection---- Equalization & neutralization---MEE------ TSDF

LTDS/LCOD----- Collection ETP (Biological Treatment)

Sand Filter ---Carbon Filter ---Gardening

Hazardous waste generation and its management.

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

intermediates are stored securely at hazardous waste storage area and sent TSDF, to

incineration and to recyclers as per the Authorization under Hazardous Waste Rules.

Pollution Control Measures The main sources of pollution from the unit are discussed

as under:

Air Pollution: The major air pollution sources from the industry are process, DG set,

boiler and thermic fluid heater. These sources are provided with stacks of adequate

height so as to disperse the emanating flue gases containing SPM, oxides of sulfur and

nitrogen without affecting the ground level concentrations and Multicyclone Dust

Collector and scrubbers are provided to the process sections with adequate stack height

as per the regulatory requirements.

Noise Pollution: There is some noise producing machineries such, as ID Fan, Blowers

etc. All these machines are spread at different places within the covered sheds. Thus, no

noise of significant level shall go outside the working area which may disturb the general

noise environment. DG set installed shall be noise free & with canopy.

Process Emission Pollution: The Complete Facility will be for N-1, Stage

Manufacturing and the process mainly involve only purification, thereby process emission

is negligible. However, scrubber will be installed if required.

Solvent recovery

Solvent recovery is an important part of API. Most of the solvent are reused in different

step of a reaction of API manufacturing



33

Method of Distillation

A method of recovering a solvent from a mother liquor in a system in which the mother

liquor also contains non-volatile matter, volatile solute and volatile solvent, and the solute

concentration is low, in which a heat pump distilling column (first column) is so operated

as to work only as a concentrating section of a distilling column by feeding a mother

liquor to the column bottom of the heat pump distilling column, contact of non-volatile

matter with the concentrating section is prevented and the column bottom liquor is sent

to an evaporator so as to separate the non-volatile matter by the evaporator, thereafter, a

vapor from the evaporator is fed to a distilling column (second column), and distillates of

first and second columns and bottoms of the second column are withdrawn as the

products. The procedures described above are carried out under specific operation

conditions.

Product Series Recovery

Penicillin

To Be Performed & Recycled after analysis

cephalosporin

Penems

For General

Oncology Mother Liquor / in process distilled solvents To Be sell to Outside Authorized Party Macrolide Block

---------------



34

4. SITE ANALYSIS

(i) Connectivity




The nearest settlement is DerraBassi is at a distance of 5 km (approx). The nearest

major railway station is Ambala Railway station is at a distance of 27 km (approx) in

South direction. Lalru and Dappar Railway stations can also be used to avail regional

trains. International Airport, Mohali is at a distance of 14.6 km (approx) in NW direction.

(ii) Land form, Land Use, Land Ownership




(iii) Topography ( along with map )

The site has been observed to be almost flat level in topography with an elevation of

310m. Map showing study area of is given in Figure No. 6

Figure:6 Google Image of the proposed project site



35

(iv) Existing Land use Pattern :


which is in FEZ and will be used for industrial development. it will be diverted to industrial

land after setting up the proposed project. No forest land is involved in the area identified

for setting up of the proposed project for manufacturing of API.

(v) Existing Infrastructure

The proposed project is Greenfield project & the land is under the possession of project

proponent.

Road links



from the project site is Ghaggar railway station at a distance 5.7 km

Soil classification :

The area can be broadly grouped into two soil types depending upon its geomorphic

features as alluvial fan and alluvial plains. Alluvial fans are deposited by hill torrents with

a wavy plain rather than a steep slope. Adjacent to the alluvial fan are the alluvial plains

which forms a part of large Indo- Gangetic Quaternary basin comprises of thick sand and

silty sand layers interbedded with silt and clay beds. The alluvial plains are of vital

economic value as it supports the dense population of the district. The soils are mainly

developed on alluvium under the dominant influence of climate followed by topography

and time. The project site comes under Alluvial plain region. The major soil type of SAS

Nagar district is weakly solonized tropical arid brown soils. The soils of the district vary in

texture generally from loam to silt clay except along the Ghagghar River & Jarmal where

some sandy patches are found in isolated areas. It may vary with the site location.

However, detailed soil investigation work to be carried out before construction work at

site.

(vi) Climatic Data from secondary sources:

Climate: SAS Nagar Mohali has a sub-tropical continental monsoon climate

characterized by a seasonal rhythm: hot summers, slightly cold winters, unreliable rainfall

and great variation in temperature (0°C to 44 °C). Inwinter, sometimes frost also occurs

during December and January. The average annual rainfall is recorded to be 617 mm.

The city also receives occasional winter rains from the west.

Average temperature Summer: The temperature in summer may rise to a maximum of

44°C.Temperatures generally remain between 35°C to 42°C.



36

Autumn: In autumn, the temperature may rise to a maximum of 36°C. Temperatures

usually remain between 16° to 27° in autumn. The minimum temperature is around 13°C.

Winter: Winters are quite cool and sometimes it gets quite chilled in Mohali. Average

temperatures in winter (November to February) remains at (max)7°C to 15 °C and (min)

0°C to 5°C.

Spring: The climate remains quite pleasant during the spring season. Temperature

varies between (max) 16°C to 25°C and (min) 9°C to 18°C.

Rainfall: The rainfall in the zone is caused by South-West monsoon. It starts in the month

of July and extend upto the month of September. During this period the monsoon rainfall

contribute about 75 to 80% of the total annual rainfall. The average annual rainfall is in

the range of 1000-1100mm. the annual number of rainy days on average are about 51 in

a year, out of which about 31 fall in the monsoon period of July to September.

Humidity: In summer months of April, May and June which is the driest part of the year,

the afternoon humidity comes down to 23% to 25% while the relative humidity during

monsoon months goes up to 75% to 80%.

Wind Speed/Direction: The wind direction in the area is mostly from North-West to

South-East. During January to May the winds are quite strong while July to October is

calm months.

Table 1.1 : Summary of climate condition

Maximum temperature 44-45°C in the month of May

Minimum temperature 4-5°C in the month of January

Relative humidity 80-82% (Max.)

Rainfall Annual – 1100-1200 mm

Wind Speed 50 m/sec.

Predominant Wind Direction From South to West

Seismic data Zone – IV as per IS-1893 (part-I)

(vii) Biodiversity:

The existing flora and fauna components in the study area. Data has been collected

through secondary sources. With the change in environmental conditions, the vegetation

cover as well as animals reflects several changes in its structure, density and

composition. The present study was carried out separately for floral and faunal

community respectively. Flora: Tree species which are most commonly found in the area



37

are Acacia arabica (Babool), Ficus religiosa (Peepal), Emblica officinalis (Amla),

Dalbergia sissoo (Shishum), Mangifera indica (Aam), Prosopis juliflora (Vilayati babool)

etc. Fauna: Commonly found animal in the study area are Common mongoose

(Herpestes edwardsi), Rat (R.rattus), Bull Frog (Rana tigrina), House crow (Corvus

splendens), Common garden lizard (Calotes vesicolor) etc. Crops: The major crops of

the district are Wheat, Paddy & Maize. The Sugarcane & Sunflower crops are also

cultivated in the district to some extent.

(viii) Socio-Economic Environment:

Socio-economic status of the population is an indicator of development of the region. Any

developmental project of any magnitude will have a bearing on the living condition and

the economic bearing of the population in particular and the region as a whole. Similarly,

the proposed project at Sector 85 & 99, SAS Nagar, Mohali will have its share of socio-

economic influence in the study area. The section delineates the overall appraisal of the

socially relevant attributes. The data on socio-economic aspects in the study area has

been carried out through the analysis of the secondary data available for the study area.

As per 2011 Indian census record, SAS Nagar (Mohali) had a population of 123,284.

Males constitute 53% of the population and females 47%. SAS Nagar (Mohali) has an

average literacy rate of 83%, higher than the national average of 59.5% : male literacy is

85%, and female literacy is 81%. In SAS Nagar (Mohali), 10% of the population is under

6 years of age.

(ix) Other features:

Rivers Medkhali Nala – 4.6 km

Dhudgarh Ki Nadi – 5 km

Dangri Nadi – 7.7 km

Jhamal Nala – 0.2 km

Dhabi Nala – 3.3 km

Chao Nala – 4.4 km

Ghagghar River 6 km.

Interstate

Boundary

Punjab-Haryana interstate boundary is at a distance of 1.8 km in east

direction.

Road

Connectivity

National Highway NH-22 is at a distance of 5.3 km.

NH-73 at a distance 9.7km in NE direction.

SH-21 at a distance 5.6km in NE direction.

Nearest

Settlement

DerraBassi is at a distance of 5 km (approx) in W direction

------------------



38

5. PLANNING BRIEF

(i) Planning concept

As per EIA Notification dated 14th September, 2006, as amended on 25 June 2014, the

project falls under activity „5(f)‟ and the presence of interstate boundary of Haryana and

Punjab within 5km from the project site in East direction makes the general condition

applicable on the project which makes it category „A‟ project. So the Proposed project will

be appraised at MOEF&CC.

(ii) Employment & Population projection

It is estimated that total 320 persons are required to ensure smooth working of the plant.

Indirect employment will also be generated from the proposed project during construction

and operation. The summary of direct employment estimate for the project is given in the

table below:

Table 1.2: Manpower Requirement

S.No. Managerial/ office staff

Supervisor Skilled Unskilled Contract/ Outsourcing

General Block 3 6 15 27 10

Betalactam 3 4 13 27 10

Cephalosporin 3 4 13 27 10

Oncology 3 4 13 27 10

QC/QA 2 2 10 6 4

Utility 1 1 3 6 5

Solvent recovery 1 1 6 4 10

Warehouse 1 1 4 10 10

Total 17 23 77 134 69

(iii) Land Use Planning

The proposed project will be set up in an area of 4.4 ha

(iv) Assessment of Infrastructure demand

The following plants, machinery proposed for the project is given in the below table:

LIST OF PLANT AND MACHINERIES:

Please refer the following enclosures for different category of machines

1. Penicillin Block

2. Cephalosporin Block

3. Penems Block

4. Macrolide Block



39

5. Hormone Block

6. Oncology Block -1&2

7. General Block

All the blocks will have 3 floor structures and each block will be divided in 2 sections through

a passage.

Section: A- Technical block

It involves the key production area with all the prerequisites.

Section; B- General block

It involves the supporting section for technical area. Including Ware House at ground floor

Detail of each floor is as per below table:

Floor Floor Plan (Plant) Floor Plan (Non-Technical) (Segregated by passage)

Ground Floor

Final Process area

Isolation room Materials staging area

Equipment cleaning

Clean equipment’s storage

Raw/Packing material storage and dispensing

Intermediate storage and dispensing

Finished goods storage and dispensing

First Floor

Reactor rooms

Staging area

Scrubber

Personnel amenities room

Shift meeting room

Engineering service area

Engineering store area

Supply chain management

Server Room

Second Floor

Auxiliary process equipment

Low temperature unit

MCC room

HVAC systems

Refrigeration plant

Quality assurance department

Quality control area

Meeting room

Administration Block:

It will the part of general administration block and following department will the part of

same:

1. Administration 2. First Aid 3. Environment health and Safety 4. Project 5. Finance 6. Cubicles for head of all section of each block



40

LIST OF MAJOR EQUIPMENT IN PENCILLIN STERILE BLOCK

S.No. Equipment Name Capacity MOC Electric load

(kw)

1 Reactor-1 Desolutor 1500 Lit SS-316 3.75

2 Reactor-2 Crystallizer 4500 Lit SS-316 3.75

3 Sparkler Filter 40.15 litre SS-316 3.75

4 Solvent tank 5000 Lit SS-317 3.75

5 Agitated Nutsche Filter Dryer 300Ltr SS-318 3.75

6 Steam Sterilizer SS 540Ltr SS-316 3.75

7 Blender Bin-1 SS 175ltr SS-316


9 Co-Mill SS 390kg/hr SS-316 3.75

10 CIP skid SS NA SS-3016

11 Dispensing System SS NA SS-316

12 Dry Heat Sterilizer (DHS) 2000 LTR SS-316 3.75

13 Dynamic Pass Box- 5 No. N.A. SS-316 3.75

14 Filter Integrity Machine N.A. PVC

15 Garment Cubicle Unit-05 N.A. SS-316 3.75

16 LAF N.A. SS-316 3.75

17 Methanol Storage Tank 5 KL SS-316 1

18 ML tank for ANFD 1 KL SS-316

19 Mobile LAF N.A. SS-316 3.75

20 Weighing Balance -02 60 kg SS-316 0.5

21 Weighing Balance 02 16.2 kg SS-316 0.5

22 Weighing Balance 32.2 kg SS-316 0.5

23 Unloading Bin -04 20LTR SS-316

24 Fogger-(06 No.) 3 LTR Fogger-06 0.5

25 Membrane Filter Holder-(04No.) NA SS-316 0

26 Washing machine-04 4.0 kg SS-304/ powder

coated 0.5

27 Washing machine for packing container Per cycle/01

container SS 3016 1

28 Non-Viable Particle Counter 0.1 M3 Fibre body

29 Non-Viable Particle Counter 0.1 M3 Fibre body

30 Container Sealing Machine-02 105 mm SS-316

LIST OF MAJOR EQUIPMENT IN STERILE CEPHALOSPORIN BLOCK


(KW)

1 Reactor-1 1500 Lit SS-316 3.75 kw

2 Reactor-2 Crystallizer 4500 Lit SS-316 3.75 kw



41


(KW)

3 Lyophilize 5000 Lit SS-316 3.75 kw

4 Sparkler Filter 40.15 litre SS-316 3.75 kw

5 Solvent tank 5000 Lit SS-317

6 Agitated Nutsche Filter Dryer 300Ltr SS-318 3.75 kw

7 Steam Sterilizer SS 540Ltr SS-316 3.75 kw



10 Co-Mill SS 390kg/hr SS-316 3.75 kw

11 CIP skid SS NA SS-3016 3.75 kw


13 Dry Heat Sterilizer (DHS) 2000 LTR SS-316 3.75 kw

14 Dynamic Pass Box- 5 No. N.A. SS-316

15 Filter Integrity Machine N.A. PVC 3.75 kw

16 Garment Cubicle Unit-05 N.A. SS-316 3.75 kw

17 LAF N.A. SS-316 3.75 kw

18 Methanol Storage Tank 5 KL SS-316 3.75 kw

19 ML tank for ANFD 1 KL SS-316 3.75 kw

20 Mobile LAF N.A. SS-316 3.75 kw

21 Weighing Balance -02 60 kg SS-316 3.75 kw

22 Weighing Balance 02 16.2 kg SS-316 3.75 kw

23 Weighing Balance 32.2 kg SS-316 3.75 kw


25 Fogger-(06 No.) 3 LTR Fogger-06 3.75 kw

26 Membrane Filter Holder-(04No.) NA SS-316

27 Washing machine-04 4.0 kg SS-304/P coated 3.75 kw

28 Washing machine for packing container

Per cycle/01 container SS 3016

3.75 kw

29 Non-Viable Particle Counter 0.1 M3 Fibre body 3.75 kw


31 Container Sealing Machine-02 105 mm SS-316 3.75 kw

LIST OF MAJOR EQUIPMENT IN API CEPHALOSPORIN BLOCK

Sr. No. Equipment Capacity Electrical Load (KW)

1 SS Reactor with condensor 3000 Liter 3.75 kw


3 SS Reactor 2000 Liter 3.75 kw


5 GL reactor 2000 Liter 3.75 kw



42

Sr. No. Equipment Capacity Electrical Load (KW)


7 Solvent Day tank 2000 Liter 3.75 kw

8 Receiver SS 500 Liter --

9 Sparkler filter 18 Inch 1.5 kw

10 Centrifuge 36,48 inches 15 kw

11 Nutsch filter 1000 Liter 10 kw

12 Heat Exchanger 5 m2 3.75 kw

13 Reactor with distillation assembly 500 Liter 3.75 kw

14 Vacuum Ejectors 25 kw

15 Blender 1000 Liter 3.75kw

16 Multimill 200 Kg/Hr. 3.75 Kw

17 Sifter 200 Kg/Hr. 3.75 kw

18 Vacuum tray drier 96 trays 15 kw

19 Steam tray drier 96 trays 10 Kw

20 Compactor 200 kg/Hr. 15 Kw

21 pass box 2’ x 2’ 1.0 kw

22 SS furniture As required --

23 SS receiver 500 Liter 5 Kw

24 Washing machine 10 kg 2.0 Kw

25 Condenser 10 m2

26 Micronizer 50 Kg/Hr. 2.0 Kw

28 FBD 500 kg 3.75 Kw

29 Blender cum filling Machine 1000 kg 3.75 Kw

LIST OF MAJOR EQUIPMENT IN API PENEM BLOCK

S.No. Equipment Capacity Electrical Load (KW)








8 Receiver SS 500 Liter --




12 Heat Exchanger 5 m2 3.75 kw





43




17 Sifter 200 Kg/Hr. 3.75 kw

18 Vacuum tray drier 96 trays 15 kw

19 Steam tray drier 96 trays 10 Kw

20 Compactor 200 kg/Hr. 15 Kw

21 pass box 2’ x 2’ 1.0 kw

22 SS furniture As required --

23 SS receiver 500 Liter 5 Kw

24 Washing machine 10 kg 2.0 Kw

25 Condenser 10 m2

26 Micronizer 50 Kg/Hr. 2.0 Kw

28 FBD 500 kg 3.75 Kw

29 Blender cum filling Machine 1000 kg 3.75 Kw

LIST OF MAJOR EQUIPMENT IN STERILE PENEM BLOCK

Sr. No. Equipment Name Capacity MOC Electric load

(KW)

1 Reactor-1 1500 Lit SS-316 3.75 kw

2 Reactor-2 Crystallizer 4500 Lit SS-316 3.75 kw

3 Lyophilize 5000 Lit SS-316 3.75 kw

4 Sparkler Filter 40.15 litre SS-316 3.75 kw

5 Solvent tank 5000 Lit SS-317

6 Agitated Nutsche Filter Dryer 300Ltr SS-318 3.75 kw

7 Steam Sterilizer SS 540Ltr SS-316 3.75 kw



10 Co-Mill SS 390kg/hr SS-316 3.75 kw

11 CIP skid SS NA SS-3016 3.75 kw


13 Dry Heat Sterilizer (DHS) 2000 LTR SS-316 3.75 kw

14 Dynamic Pass Box- 5 No. N.A. SS-316

15 Filter Integrity Machine N.A. PVC 3.75 kw

16 Garment Cubicle Unit-05 N.A. SS-316 3.75 kw

17 LAF N.A. SS-316 3.75 kw

18 Methanol Storage Tank 5 KL SS-316 3.75 kw

19 ML tank for ANFD 1 KL SS-316 3.75 kw

20 Mobile LAF N.A. SS-316 3.75 kw

21 Weighing Balance -02 60 kg SS-316 3.75 kw



44

Sr. No. Equipment Name Capacity MOC Electric load

(KW)

22 Weighing Balance 02 16.2 kg SS-316 3.75 kw

23 Weighing Balance 32.2 kg SS-316 3.75 kw


25 Fogger-(06 No.) 3 LTR Fogger-06 3.75 kw

26 Membrane Filter Holder-(04No.) NA SS-316

27 Washing machine-04 4.0 kg SS-304/P coated 3.75 kw

28 Washing machine for packing container

Per cycle/01 container

SS 3016 3.75 kw



31 Container Sealing Machine-02 105 mm SS-316 3.75 kw

LIST OF MAJOR EQUIPMENT IN API MACROLIDES BLOCK



2 SS Reactor 700 Liter


4 GL reactor 1500 Liter






10 Isolator with nutch filter and VTD 12 tray ----

11 Tank SS with circulation 2000KL 3.75


12 Receiver SS 200 Liter ---





17 Agitated Nutsch filter 2 No. 1000 Liter 10 kw

18 Heat Exchanger 5 m2 3.75


20 Vacuum Ejectors 2 25 kw

21 Water in 3.75

22 Dry vacuum pump 3.75



45




25 Sifter 2 in closed 200 Kg/Hr 3.75 kw

26 pass box 4 no 2’ x 2’ 1.0 kw

27 SS furniture ---

28 Condenser 6 5-10 m2 ---

29 Cold storage (2-8C) 6X4 6.5 kw

30 Cold storage (-15C) 6X4 6.5 kw

LIST OF MAJOR EQUIPMENT IN API HARMONE BLOCK



2 SS Reactor 700 Liter








10 Isolator with nautch filter and VTD 12 tray ----



12 Receiver SS 200 Liter ---





17 Agitated Nutsch filter 2 No. 1000 Liter 10 kw

18 Heat Exchanger 5 m2 3.75


20 Vacuum Ejectors 2 25 kw

21 Water in 3.75

22 Dry vacuum pump 3.75



25 Sifter 2 in closed 200 Kg/Hr. 3.75 kw

26 pass box 4 no 2’ x 2’ 1.0 kw

27 SS furniture ---

28 Condenser 6 5-10 m2 ---




46



LIST OF MAJOR EQUIPMENT IN STERILE ONCOLOGY BLOCK


1 SS Reactor 1000 Litter 3.75 kw


3 GL reactor 2000 Litter 3.75 kw




7 GL reactor 1000 Litter 15kw

8 Nutsch filter 300 Litter 10 kw

9 Nutsch filter 100 Litter 10 kw

10 Isolator with nutch filter and VTD 12 tray

---- 3.75kw

11 Tank SS with circulation 2000KL 3.75kw

11 Tank SS with circulation 2000KL 3.75 kw

12 Solvent Day tank 2000 Litter 3.75 kw




16 Agitated Nutsch filter 2 No. 1000 Litter 10 kw

17 Heat Exchanger 5 m2 3.75kw

18 Reactor with distillation assembly 500 Litter 3.75 kw

19 Vacuum Ejectors 2 …. 25 kw

20 Water in …. 3.75 kw

21 Dry vacuum pump … 3.75kw

22 Blender 20 Litter 3.75kw

23 Multimill 50 Kg/Hr 3.75 Kw

24 Sifter 2 in closed 200 Kg/Hr 3.75 kw

25 Pass box 4 no 2’ x 2’ 1.0 kw

26 SS furniture 1.0 kw

27 Condenser 6 5-10 m2 1.0 kw



LIST OF MAJOR EQUIPMENT IN STERILE GENERAL BLOCK








47



6 Filtration train Automatic 1.5 kw

7 Crystallizer 1000 Liter 3.75 kw

8 Agitated Nutsch filter drier 1 m2 7.5 kw

9 Auto filling machine 500 Liter 3.75 kw



12 Cartridge filter with housing Pre and final

13 Electronic balance 30 Kg,50 Kg 0.5 kw

14 Air shower 4’ x 4’ x 7’ 1.9 kw

15 Steam sterilizer 900x900x1200 4 Kw

16 Dry heat sterilizer 1200x1200x1800 30 Kw

17 Dynamic pass box 2’ x 2’ 1.0 kw

18 SS furniture

19 Hanging LAFs 4’ x 4’ 5 Kw

20 Canister washing machine 6 canisters at time 2.0 Kw

21 Filter integrity machine

LIST OF MAJOR EQUIPMENT IN GENERAL (MULTIPURPOSE) API BLOCK


1 SS coil reactor with Condenser 1500 liter 3.75

2 SS reactor 3000liter 3.75

3 SS Reactor crys. 5000liter 3.75

4 SS Reactor crys. 5000liter 3.75

5 SS Reactor with Condenser 3000liter 5

6 SS Reactor 1500liter 375

7 MSGL Reactor 500liter 3.75

8 MSGL Reactor 4000liter 5

9 SS Reactor 3000liter 3.76

11 SS centrifuge with MLT and Pump 48" 25

12 SS centrifuge MLT and Pump 48" 25

14 SS Sparkler filter 24X18 1




19 SS/MS Tank 1500liter 0.5

20 SS /MS Tank 2500liter 0.5

21 SS Tank 2500liter 0.5






13 Blender 1000 Liter 0.5

14 Multi mill 200 Kg/Hr. 0.1



48


15 Sifter 200 Kg/Hr. 0.05

16 Vacuum tray drier 24 trays 0.75

17 Vacuum tray drier 24 trays 0.75

18 Compactor 200 kg/Hr. 0.25

19 Pass box 2’ x 2’ 0.05

20 SS furniture 0.25

21 SS receiver 500 Liter 0.25

22 SS receiver 4000Ltr 0.25

23 SS receiver 3000Ltr 0.25

24 Washing machine 10 kg 0.05

25 Condenser 10 m2 0.2

26 Micronizer 50 Kg/Hr. 0.5

27 FBD 500 kg 0.25

28 Cold storage (2-8C) 6X4 0.25

29 Cold storage (-15C) 6X4 0.25

(v) Amenities/Facilities

Facilities like canteen, rest rooms and recreation facilities will be provided in the

proposed project. No other additional facilities are proposed.

------------------



49

6. PROPOSED INFRASTRUCTURE

(i) Total Area:

Total Plot area is 4.4 ha.

Residential Area :

There is no residential area proposed within the proposed project site.

(ii) Green Belt :

Total land area of the proposed project is 4.4 ha. The greenbelt will also be developed at

the site whose area is estimated as 1.4 ha. Adequate green belt provision as per

MoEFCC guideline has already been considered for proposed project development.

Further, unpaved areas if any, within the plant boundary will be provided with grass cover

which will also improve the plant aesthetics.

(iii) Social Infrastructure

Schools, Colleges, Hospitals & Healthcare Centers, Shops & Bazaars and Community

Centers etc. are all available in nearby Village- Bhagwanpur, Tehsil- Derabassi, District-

S.A.S Nagar, State- Punjab

Connectivity

The proposed plant site is well connected with the rail and road connectivity. The site is

about 5.3 km from NH-22(Ambala-Chandigarh express way). The nearest settlement is

Tohffapur is at a distance of 1 km (approx) in NW direction. The nearest major railway

station is Ambala Railway station is at a distance of 17.7 km (approx) in South direction.

Lalru and Dappar Railway stations can also be used to avail regional trains. International

Airport, Mohali is at a distance of 14.6 km (approx) in NNW direction respectively from

the project site.

(iv) Water Requirement & Treatment System

Water is a component of every pharmaceutical product, so water system must be

validated to ensure the consistent production of high quality water. The pharmaceutical

industry places a high priority on the quality of water used in production of finished

product, intermediate reagent preparation & analytical processes & especially in case of

parenteral products where quality of water must be as per Pharmacopoeia. In present

scenario the quality of pharmaceutical water is maintained by setting a good

pharmaceutical water system and this system encompasses system design qualification,



50

attention of the regulatory requirements which are updated time to time. The continuous

monitoring of water system is an unequivocal regulatory requirement and a major cost

strain on company personnel and resources. Proper water system planning with

personnel knowledge in all the physical, chemical, engineering and microbiology issues

associated with water is essential. Proper pharmaceutical water system must

1. Achieve & maintain compliance with pharmacopoeia requirements.

2. Have proper sampling system from correct points with appropriate frequency.

3. Troubleshoot common contamination problems.

4. Consistently produce water that meets industry standards for quality.

The water requirement of the unit will be met from bore well. The daily requirement of

water for unit is 572 KLD. About 200 KLD water will be required in process & make up

water required for cooling purpose will be 100 KLD. Water required for boiler will be 160

KLD and for domestic purpose 30 KLD.

Detail of water balance is given below

-----------

S.No. Purpose Water requirement KLD

1 Process 200

2 Reactor & Floor Washing 40

3 Boiler Blow Down 160

4 Cooling Tower Blow Down 100

5 Scrubbing system 20

6 DM Plant 20

7 Domestic 30

8 Green Belt 2

Total 572



51

7. REHABILITATION & RESETTLEMENT PLAN

No agricultural land and habitation is present in the land and there is no displacement

involved. Hence, no Land Acquisition, Resettlement and Rehabilitation is envisaged for

this project..



52

8. PROJECT SCHEDULE & COST ESTIMATES

(i) Likely date of start of Construction and likely date of completion

(Implementation schedule) :

The construction of the project shall commence soon after receipt of Environment

Clearance from MoEF& CC and CTE from PPCB. The project execution schedule shall

be another 18 months after getting project clearance/ environment clearance.

(ii) Estimated Project Cost

The capital cost of the project is worked out to be Rs 100 Crore including preliminary &

pre-operative expenses, working capital requirement and presented in the table below:

Table 1.5 : Total Cost

-------------------

S.No. Area Cost (Cr.)

1 API Blocks

100

2 Solvent Recovery

3 QA and QC

4 Ware house

5 Utilities

6 Building and modular partitions

7 ETP

Total 100



53

9. ANALYSIS OF PROPOSAL (Final Recommendation)

The Indian Pharmaceuticals Industry (IPI) earns around 70% of its revenues from sale of

generic drugs and generates around 50% of its revenues from exports. In the financial

year 2016-17, the industry faced slew of issues with increased scrutiny of regulatory

authorities, increase in competition in generics market of one of its primary export

destination, United States of America. This, in turn, resulted in marginal growth in exports

to USA. Also, the stricter enforcement of Drug Price Control Order has impacted revenue

growth rate of the industry in domestic market.

In 2017-18, the industry is expected to continue to see pricing pressure in both the

markets: domestic and exports. However, CARE believes that the steady growth in

demand from domestic market coupled by a likely increase in export volumes to North

American and African markets will support the industry‟s growth.

The project is envisaged to meet the demand supply gap of domestic & international

market, as the the Indian pharmaceuticals market is the 3rd largest in terms of volume

and 13th largest in terms of value. India is the largest provider of generic drugs globally

with the Indian generics accounting for 20 % of global exports in terms of volume. Of

late, consolidation has become an important characteristic of the Indian pharmaceutical

market as the industry is highly fragmented.

The Indian pharma industry, which is expected to grow over 15 % per annum between

2015 and 2020, will outperform the global pharma industry, which is set to grow at an

annual rate of 5 % between the same period. The market is expected to grow to US$ 55

billion by 2020, thereby emerging as the 6th largest pharmaceutical market globally by

absolute size. Branded generics dominate the pharmaceuticals market, constituting

nearly 80 % of the market share (in terms of revenues).

The benefits of this project includes:

The project site shall require no displacement of habitation as it is located away

from the habitation area & will be developed on the industrial land (FEZ).

Socio-economic benefit to the locals as it would provide both direct

employment and indirect employment.

This new project will also attract generation of addition revenue to the

Government by means of Taxes and duties.

So considering the above the M/s United Biotech Private Limited is proposing to setup a

new API manufacturing unit at Village- Bhagwanpur, Tehsil- Derabassi, District- S.A.S

Nagar, State- Punjab.

form-1 and pre-feasibility reportenvironmentclearance.nic.in/writereaddata/online/tor/25...d-142,...

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