Pre Feasibility...

PRE - FEASIBILITY REPORT

For

Proposed for Expansion of Existing Bulk Drug

Intermediate Manufacturing Unit to Bulk Drugs

Manufacturing Unit

(PRODUCTION CAPACITY: 23.885 TONNES/MONTH)

at

PLOT NO: 170 , 171 &172, PHASE –II, IDA PASHAMYLARAM,

PATANCHERU (MANDAL), SANGAREDDY (DISTRICT),

TELANGANA STATE

By

SANOZEN PHARMA PRIVATE LIMITED

March, 2019

Contents

S. No. Description Page no.

1.0 Executive Summary 1 – 2

2.0 Introduction of The Proposed Project 2

2.2 Brief description of nature of the project. 2

2.3 Need for the project and its importance to the country and

or region 3 – 4

2.4 Demand-Supply Gap. 4

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

4 – 5

3.0 Project description 5 – 7

3.1 Product and Production Capacity 8 – 9

3.2 Raw materials required and Quantities 9

3.3 Manufacturing Process 10

3.4 Resource – Utilize and Recycling 10

3.4.1 Water 10 – 11

3.4.2 Power Requirement 11

3.4.3 Fuel Requirement 11

3.5 Quantity of wastes to be generated 11

3.5.1 Waste Water Generation and utilization 11 – 12

3.5.2 Solid waste generation and Disposal 12

3.6 Schematic representations of the feasibility drawing which give information of EIA purpose.

12 – 13

4.0 Site Analysis 13

4.1 Connectivity 13

4.2 Land Form, Land use and Land ownership. 13

4.3 Existing Infrastructure 13

4.4 Soil classification 13

4.5 Climatic data from secondary sources. 13

4.6 Social Infrastructure available. 14

5.0 Brief Planning 14

6.0 Proposed infrastructure 14

6.1 Industrial Area 14

6.2 Residential Area 14

6.3 Green Belt 14

6.4 Social Infrastructure 14 – 15

6.5 Water management 15

6.6 Sewerage System 15

6.7 Industrial Waste Management 15

7.0 Rehabilitation and Resettlement (R&R) Plan 15

8.0 Project Schedule and Cost estimates 15

9.0 Analysis of project 15

LIST OF TABLES

LIST OF FIGURES

Figure No Description Page no.

1.1 Location Map 6

1.2 Google Earth Map Showing Sanozen Pharma Private

Limited 7

LIST OF FLOW CHART

Table No Description Page no.

2.1 Details of Proposed Employment for Proposed Project. 5

3.1 Proposed Products and Quantities & By Products Details

8 – 9

3.2 Water Requirement Details 10

3.3 Wastewater generation and Treatment Method 11

3.4 Solid and hazardous waste generation and Disposal 12

8.1 Project Cost 15

Flow Chart No

Description Page no.

3.1 Generalized Flow Chart for Bulk Drug Manufacturing 10

Pre Feasibility Report

Sanozen Pharma Private Limited Page 1

1.0 EXECUTIVE SUMMARY

Sanozen Parma Private Limited is an existing Bulk Drug Intermediate

manufacturing unit and proposing for expansion of existing unit. The company

proposed to purchase the adjacent R & D unit namely SP Labs Private Limited for

the proposed expansion purpose. The proposed production quantity is 23.885

Tonns/Month.

S. No Parameter Description

1 Project Location Plot No: 170 , 171 &172 , Phase – II, IDA

Pashamylaram, Patancheru (Mandal),

Sangareddy (District), Telangana State

2 Category of Project as per EIA

Notification & Amendments

5(f) “B”

The Unit is Located in Notified Industrial Estate,

In view of absence of SEAC/SEIAA Telangana

State, Hence applying to MoEF & CC, New

Delhi for grant of ToR .

3 Project cost 18 Crores for proposed expansion

4 Area

The existing unit is in area of 1620.70 Sqm in

plot No: 170 and for the proposed expansion

the Sanozen Pharma Pvt Ltd purchased Plot

nos: 171 &172 of SP Labs Private Limited (R

&D Unit adjacent to the existing Unit) in an

Area of 4607.89 Sqm.

The total area for the proposed expansion is

6228.59 Sqm

5 Proposed Products Proposed Products List is mentioned in section

3.1

6 Resources

7 (I)Electricity Requirement 900 KVA

Source of electricity

Telangana State Power Distribution Company

Limited (TSPDCL)

D. G. Sets

DG Set:

Existing: 65 KVA (Sanozen Pharma Private Limited) –Dropped & 125 KVA (SP labs Private Limited) –Dropped Proposed : 500 KVA DG Set

8 (II)Water consumption 78.48 KLD



Source of water TSIIC Supply

Waste water generation 24.39 KLD

9 (III)Boiler

Existing Boilers:

2 TPH (Sanozen Pharma Private Limited) –

Continued

1 TPH (SP Labs Private Limited) – Continued

Existing 1 TPH & 2 TPH Boilers will be

continued for proposed expansion

10 (IV)Fuel Coal – 10.5 MT /Day for Boilers Operation

11 Mode of disposal Zero Liquid Discharge System

12 Solid waste generation Mentioned in Para 3.5.2 of report

13 Nearest Highway Hyderabad – Mumbai National Highway 9 – 1.4

Km (NNE)

14 Nearest Railway Station Shankarpally Railway Station – 12 Kms (SSW)

15 Nearest Airport Rajeev Gandhi International Airport - 43 Kms

(SE)

2.0 INTRODUCTION OF THE PROPOSED PROJECT

The objective of this pre- feasibility study is to provide information for the proposed

expansion of existing unit by Sanozen Pharma Private Limited at Plot No: 170, 171

&172, Phase – II, IDA Pashamylaram, Patancheru (Mandal), Sangareddy (District),

Telangana State.

Project Proponents:

Shri J Sanjeeva Reddy is the Managing Director and having more than two

decades of rich industrial experience in this line of activity. He supervises the overall

affairs of the company.

Mrs. J. Parvathi Devi is the Director of company and has work experience more

than 20years in different bulk drug industries.

2.1 Brief description of nature of the project.

Sanozen Pharma Private Limited is an existing Bulk Drug Intermediate

manufacturing unit and proposing for expansion of existing unit. The company

proposed to purchase the adjacent R & D unit namely SP Labs Private Limited for

https://en.wikipedia.org/wiki/Hyderabad



the proposed expansion purpose. The proposed production quantity is 23.885

Tonns/Month.

2.2 Need for the project and its importance to the country and or region

Sanozen Pharma Private Limited intended to expand the Bulk Drugs manufacturing

capacity with additional area at Plot No: 170, 171 &172, Phase – II, IDA

Pashamylaram, Patancheru (Mandal), Sangareddy (District), Telangana State.

Availability of the well-connected road and railway network for easy

transportation of the construction equipments and materials, Raw materials

and finished products.

Easy availability of skilled and unskilled labor for construction of Plant and its

operation.

The global demand for cancer drugs market was valued at approximately $ 112.90

billion in 2015 and is expected to generate revenue of around $ 161.30 billion by end

of 2021, growing at a CAGR of around 7.4 per cent between 2016 and 2021.

India is the largest provider of generic drugs globally. Indian pharmaceutical sector

industry supplies over 50 per cent of global demand for various vaccines, 40 per cent

of generic demand in the US and 25 per cent of all medicine in UK.

India enjoys an important position in the global pharmaceuticals sector. The country

also has a large pool of scientists and engineers who have the potential to steer the

industry ahead to an even higher level.

The pharmaceutical sector was valued at US$ 33 billion in 2017. The country’s

pharmaceutical industry is expected to expand at a CAGR of 22.4 per cent over

2015–20 to reach US$ 55 billion. India’s pharmaceutical exports stood at US$ 17.27

billion in FY18 and have reached US$ 10.80 billion in FY19 (up to October 2018).

Pharmaceutical exports include bulk drugs, intermediates, drug formulations,

biologicals, Ayush & herbal products and surgicals.

Indian companies received 304 Abbreviated New Drug Application (ANDA)

approvals from the US Food and Drug Administration (USFDA) in 2017. The country

accounts for around 30 per cent (by volume) and about 10 per cent (value) in the

US$ 70-80 billion US generics market.



India's biotechnology industry comprising bio-pharmaceuticals, bio-services, bio-

agriculture, bio-industry and bioinformatics is expected grow at an average growth

rate of around 30 per cent a year and reach US$ 100 billion by 2025.

Recognizing the scope of the potentials the Govt. of telangana has put more

emphasis on the development of Pharma industry and announced series of

incentives and subsidies. This scenario is helping to setup new manufacturing units.

It is pertinent to notice that, various industrial authorities of India that there is evenly

increase in knowhow about pharmaceutical products manufacturing in India, it is

seen that there is demand for pharmaceutical products in India as the substantial

population of globe resides in Asia itself.

2.3 Demand-Supply Gap

There is a quite considerable gap between supply and demand for, fine chemicals,

bulk drugs and intermediates. Very few players are in the market who can offer

continuous supply. The company wants to bridge this gap between demand and

supply by expanding the production capacity and thereby, making good business.

Company's marketing edge comes from its direct and close contact with the

customers. Their products are major strength of their customers. Each stage of their

product is been monitored /checked for their quality to ensure quality product

reaches their customer. They plan to launch new products every year to satisfy the

need of their customers as per the market demand.

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

Approximate employment generation due to proposed expansion proposal is 40.

Apart from this there will be significant non estimated employment generation at the

supplier firms and service industry providing services to the company. Company

shall be giving preference to people from economically weaker sections for

employment in various semi-skilled/unskilled jobs thereby contributing to their

upliftment.



Table 2.1: Details of Proposed Employment for Project

Sl. No. Manpower Total No.

1 Un-Skilled 10

2 Skilled 20

3 Managerial &Supervisory 10

3.0 Project Description

Sanozen Pharma Private Limited is proposing to Manufacture Bulk Drugs with

production capacity of 23.885 TPM

The Location map is shown at Figure - 3.1 and Google earth map showing Sanozen

Pharma Private Limited plant is shown at Figure - 3.2.

The site coordinates are

Latitude: 17°32'35.61"N

Longitude: 78°11'1.53"E

The project site does not offer any negative impact on the local area, but rather has

a positive impact on socio economic conditions of the habitants around it because of

employment to locals.

The Sanozen Pharma Private Limited is 1.4 Kms away from away from Hyderabad

– Mumbai National Highway and 12 Kms from Shankarpally Railway Station.



FIGURE 1.1: LOCATION MAP

Sanozen Pharma Private Limited



FIGURE 1.2: GOOGLE EARTH MAP SHOWING SANOZEN PHARMA PRIVATE LIMITED

PRE FEASIBILITY REPORT


3.1 Product and Production Capacity

Sanozen Pharma Private Limited proposing to produce below mention products

with Manufacturing Capacity of 23.885 TPM and the list of products and by-products

are shown in Table 3.1.

Table 3.1: Proposed Product and Quantity for Expansion

S.

No Product Name

Quantity

In Kg/Month CAS No

Therapeutic

Category

1 Amifostine 50 20537-88-6 Anti cancer

2 Anastrozole 100 120511-73-1 Anti Neoplastic

3 Bendamustine

hydrochloride 25 3543-75-7 Anti cancer

4 Bortezomib 5 179324-69-7 Anti cancer

5 Chlorambucil 50 305-03-3 Anti cancer

6 Cisplatin 20 15663-27-1 Anti cancer

7 Citalopram Hydrobromide 5000 59729-32-7 Anti Depressant

8 Dacarbazine 25 4342-03-4 Anti cancer

9 Dasatinib Monohydrate 200 863127-77-9 Anti Leukemia

10 Docetaxel 25 114977-28-5 Anti cancer

11 Dapoxetine Hydrochloride 120 129938-20-1 Anti Coagulant

12 Erlotinib 250 183321-74-6 Anti cancer

13 Gefitinib 500 184475-35-2 Anti cancer

14 Imatinib Mesylate 350 220127-57-1 Anti Neoplastic

15 Lapatinib Ditosylate

Monohydrate 100 388082-78-8 Anti Neoplastic

16 Ledipasvir 150 1256388-51-8 Hepatitis-C

17 Letrozole 50 112809-51-5 Anti Neoplastic

18 Lomustine 15 13010-47-4 Anti Neoplastic

19 Melphalan 50 148-82-3 Anti cancer

20 Methotrexate 75 59-05-2 Anti cancer

21 Nilotinib hydrochloride

Hydrate 150 923288-95-3 Anti Neoplastic

22 Oxaliplatin 40 63121-00-6 Anti Neoplastic



S.

No Product Name

Quantity

In Kg/Month CAS No

Therapeutic

Category

23 Paclitaxel 15 33069-62-4 Anti cancer

24 Pazopanib hydrochloride 200 63570-64-6 Anti Neoplastic

25 Ponatinib 200 943319-70-8 Anti Leukemia

26 Premetrexed disodium 150 150399-23-8 Anti cancer

27 Procarbazine 20 671-16-9 Anti cancer

28 Raltegravir 5000 518048-05-0 Anti Retroviral

29 Regorafenib 100 755037-03-7 Anti Angiogenic

30 Sofosbuvir 500 1190307-88-0 Hepatitis-C

31 Sorafenib Tosylate 200 475207-59-1 Anti Neoplastic

32 Telmisartan 5000 144701-48-4 Anti Hypertensive

33 Temozolomide 50 85622-93-1 Anti cancer

34 Verapamil Hydrochloride 5000 152-11-4 Anti arrhythmic

35 Zoledronic Acid 100 118072-93-8 Calcium Regulator

Total 23885

Table 3.1: List of By-products

S. No Name of the

Product Name of the By-Product

Quantity in Kg/Day

1 Dapoxetine hydrochloride

(D)+ Tartaric acid (135.09) 4.50

2 Imatinib mesylate Dimethylamine (51.17) 1.70

3 Ledipasvir Ethyl Benzene (26.60) 2.66

4 Nilotinib hydrochloride hydrate

Dimethylamine (15.04) 0.50

5 Ponatinib

Succinamide (91.82) 3.06

Diisopropylamine (72.16) 2.40

Triethylamine Hydrochloride (75.65) 2.52

6 Procarbazine Succinamide (16.30) 0.54

3.2 Raw materials required and Quantities

All the raw materials required for manufacturing of above products will be sourced

from local market. The products wise required raw materials and quantities are

enclosed in additional information.



3.3 Manufacturing Process

The manufacturing process of bulk drugs consists of chemical synthesis extending

to stages of processing involving different type of chemical reactions. The

generalized Flow chart for bulk drug manufacturing is shown in Flow chart 3.1.

Flow Chart 3.1: Generalized Flow Chart for Bulk Drug Manufacturing

3.4 Resource – Utilize & Recycling

3.4.1 Water

Water requirement of the project for Process, washings, Boiler Makeup, Cooling

Tower makeup and Domestic during operation phase will be 78.48 KLD. The water

requirement will be met through TSIIC Supply. The detailed water requirement

shown in below Table 3.2

Table 3.2: WATER REQUIREMENT DETAILS

S. No. Purpose Water Requirement

in KLD

1 Process 11.48

2 Washings 1.0

3 Boiler make up 18.00

4 Cooling towers make up 42.00

5 Scrubbing system 1.00

6 Domestic 2.00

7 Gardening 3.00

Total 78.48



3.4.2 Power Requirement

Power requirement of proposed project will be made available through Telangana

State Power Distribution Company Limited (TSSPDCL) .The total power requirement

for the unit is 900 KVA respectively

The existing unit Sanozen Pharma Private Limited has 65 KVA and SP labs Private

Limited have 125 KVA. The 2 DG set will be dropped and proposed to install new

DG set of 500 KVA capacity to meet the emergency power requirement of the plant.

3.4.3 Fuel Requirement

The existing unit Sanozen Pharma Private Limited has 2 TPH Coal fired boiler and

SP labs Private Limited have 1 TPH Coal fired Boiler.

No Additional boilers are proposed for expansion and the existing 1 TPH and 2 TPH

boilers will be continued.

The total Coal requirement will be around 10.5 TPD and it will be procured from

local sources.

3.5 Quantity of wastes to be generated

3.5.1 Waste Water Generation and utilization

Total effluent generated in the project is 24.39 KLD. The treated water will be reused

for plant operations.

The HTDS waste water from Process after neutralization taken for treatment in

stripper followed by MEE and ATFD. LTDS waste water including domestic sewage,

floor Washes, Utilities waste water taken along with Vapour Condensate from MEE &

ATFD for Biological Effluent Treatment plant. Treated effluent from ETP sent to RO

and RO permeate water is recycled and RO rejects are sent to MEE followed by

ATFD for evaporation. Evaporation salts collected and sent to TSDF. MEE & ATFD

vapour condensate reused along with RO permeate.

Table 3.3: Wastewater generation and Treatment Method

S. No

Unit HTDS KLD

LTDS KLD

Effluent Generation

in KLD Treatment Method

1 Process 10.82 3.07 13.89 HTDS: HTDS effluents sent to MEE system followed by ETP. LTDS: LTDS effluents treated in ETP – RO Plant. RO Rejects to MEE System

2 Washings 0.00 1.00 1.00

3 Boiler Blow down

0.00 3.00 3.00

4 Cooling towers Bleed off

0.00 4.00 4.00

5 Scrubbing 1.00 0.00 1.00



S. No

Unit HTDS KLD

LTDS KLD

Effluent Generation

in KLD Treatment Method

system and RO permeate to reuse, Condensate from MEE to reuse and MEE residue to ATFD.

6 Domestic 0.00 1.50 1.50

Total 11.82 12.57 24.39

3.5.2 Solid / Hazardous waste generation and Disposal

The types of Solid and Hazardous wastes generated from the project, method of

disposal is shown in below table 3.4.

Table 3.4: Solid / Hazardous waste generation and Disposal

S. No Name of the

Hazardous /Solid Waste Quantity

Disposal Method

1 Organic solid waste (Process Residue)

1734 Kg/Day Sent to Cement Industries

2 Spent Carbon 31 Kg/Day Sent to Cement Industries

3 Solvent Distillation Residue 288 Kg/Day Sent to Cement Industries

4 Inorganic Solid Waste 22 Kg/Day Sent to TSDF

5 ETP Sludge 20 Kg/Day Sent to TSDF

6 MEE Salts 1529 Kg/Day Sent to TSDF

7 Organic distillate from MEE Stripper

350 Kg/Day Sent to Cement Industry

8 Used Oils 100

Ltrs/Annum

SPCB Authorized Agencies for Reprocessing/Recycling

9 Detoxified Containers 300

No’s / Month After Detoxification sent to authorized agencies.

10

Used Lead Acid Batteries 2 No’s/ Annum Send back to suppliers for buyback of New Batteries

Solid waste details

11 Ash from boiler 3675 Kg/Day Sent to Brick Manufacturers

3.6 Schematic representations of the feasibility drawing which give

information of EIA purpose.

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

by considering different possibilities & provision made in the said notification.

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

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

Notification SO 1533.

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



by applying to MoEF & CC along with the Environmental Impacts Assessment Study

Report for the proposed project prior to commissioning of the project activities.

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

for Category 5(f) “B” of schedule –I of the notification. The Public Hearing may be

exempted as the unit located in Notified Industrial area before 2006.

The Unit is Located in Notified Industrial Estate established before 2006, the G.O. of

Notified IDA is enclosed as Enclosure – II. In view of absence of SEAC/SEIAA

Telangana State, We are submitting our proposal to MoEF & CC, New Delhi for

grant of ToR .

4.0. Site Analysis

4.1 Connectivity

The nearest habitation from the site is Isnapur Village at a distance of 1.5 Kms

(ESE).

The nearest railway station is at Shankarpally Railway Station at a distance of 12

Kms (SSW) from the site.

The nearest airport is Rajeev Gandhi International Airport at a distance of 43

Km (SE)

The Nearest road ways is Hyderabad – Mumbai National Highway – 1.4 Km (NNE)

4.2 Land Form, Land use and Land ownership.

The land use of the area is Industrial purpose only and located in notified industrial

area , hence no change in land use of the area.

4.3 Existing Infrastructure.

The proposed project is a expansion project which Hyderabad – Mumbai National

Highway – 1.4 Km (NNE) and Mandal head quarters Patancheru is at 8.4 Km (E)

from the site.

4.4 Soil classification

The predominant soils in the district are

Red soils Sandy soils Black Cotton soils





4.5 Climatic data from secondary sources.

Temperature Maximum: 43.8 oC

Minimum: 8.7 oC

Average Annual Rainfall: 1051.6 mm

(Source: IMD- Medak)

4.6 Social Infrastructure available.

Well developed social infrastructure facilities are available at nearby Habitations.

5.0 Brief Planning

Proposed expansion activities will be started after getting statutory clearance form

related authorities. The expansion will be completed within two years.

Further proposed expansion activities will take care of all the rules and regulations

of statutory authorities and provide the control measure and devices to achieve the

standard norms

6.0 Proposed Infrastructure

6.1 Industrial Area

The infrastructure and other facilities are already well developed in Patancheru

which is a Mandal head quarters.

6.2 Residential Area

The employees who will work in the industry are from nearby habitations and hence

no proposal for residential area for employees.

6.3 Green Belt:

Proposed to develop green belt in an area of 2474.17 Sq. mtrs, i.e 39.72 % out of

the total area 6228.59 Sq. mtrs

6.4 Social Infrastructure:

Facilities like roads, communication: Banks, ATM's and medical facilities are

adequate.

Amenities:

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

social welfare hostels.

Medical and Health- Community Health Centre & Primary Health center and all



multispecialty Medical facilities are available at Patancheru which is 8.4 Kms (E) of

existing unit.

Power and water- All the villages are electrified and drinking water facilities are

extended to all villages.

Rail and Road- The project site is very well connected by road at 1.4 kms away from

Hyderabad –Mumbai National Highway and nearest railway station is Shankarpalli at

a distance of 12 Km

6.5 Water management

Water requirement will be met from TSIIC supply.

6.6 Sewerage System:

There will be no discharge of industrial effluent as company proposing Zero Liquid

Discharge (ZLD) system. The treated effluent will be reused.

6.7 Industrial Waste Management:

The effluent from cooling and Plant/Equipment washing will be generated and

treated in the well designed Effluent Treatment Plant. The treated effluent will be

reused.

7.0 Rehabilitation and Resettlement (R & R) Plan

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

8.0 Project Schedule & Cost Estimates

The project cost for proposed activity is 18 Crores will be used for constructing

additional building, Equipments & misc.

TABLE 8.1: PROJECT COST

S. No Particulars Rs. Crores

1 SP Labs Private limited (Land , Building and P &M)

9.5

2 Civil Works 2.5

3 Plant & Machinery 6.0

Total 18.0

9.0 Analysis of proposal (Final Recommendations)

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

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

income.

Company will contribute in improving education and health facilities in nearby

area.

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