HEMDEEP ORGANICS PVT LTD ,HEMDEEP ORGANICS PVT LTD ,

ANKLESHWARANKLESHWAR

LOCATIONLOCATION

HEMDEEP ORGANICS PVT LTD GIDC, Ankleshwar -393002Bharuch(Gujarat)

An ISO-9001-2008 Certified CompanyAn ISO-9001-2008 Certified Company

State GMP certified company State GMP certified company

Manufacturing Permission from FDCA,Gujarat Manufacturing Permission from FDCA,Gujarat

as per Schedule Mas per Schedule M

Manufacturers of Drug Substances and Their Manufacturers of Drug Substances and Their intermediates intermediates

Privately owned companyPrivately owned company

PATH WAY PATH WAY • ““HEMDEEP ORGANICS PVT LTD HEMDEEP ORGANICS PVT LTD belong to Parnasha group of belong to Parnasha group of

companies, engaged in manufacturing of Active pharmaceutical companies, engaged in manufacturing of Active pharmaceutical ingredients and drug Intermediates on large scale in India.ingredients and drug Intermediates on large scale in India.

• The plant under banner of HEMDEEP ORGANICS PVT LTD is The plant under banner of HEMDEEP ORGANICS PVT LTD is situated at 320 km. away from Mumbai in district Bharuch in Gujarat situated at 320 km. away from Mumbai in district Bharuch in Gujarat state in India. The total plant area is 3000 sq. metre. Located in state in India. The total plant area is 3000 sq. metre. Located in GIDC, area, Ankleshwar-393002 GIDC, area, Ankleshwar-393002

• It is into It is into development, manufacture and marketing of drug development, manufacture and marketing of drug intermediates, APIs .intermediates, APIs .

• HEMDEEP ORGANICS PVT LTD was take over by parnasha HEMDEEP ORGANICS PVT LTD was take over by parnasha group in 2014 by Mr. L.M.Gami (Chairman). group in 2014 by Mr. L.M.Gami (Chairman).

Quality PolicyQuality PolicyHemdeep organics pvt ltd manufactures and markets drug substances and their intermediates, which Hemdeep organics pvt ltd manufactures and markets drug substances and their intermediates, which will satisfy continuing needs of our customers. will satisfy continuing needs of our customers.

This will be achieved by application of sound Quality Management System and adopting current This will be achieved by application of sound Quality Management System and adopting current Good Manufacturing Practices and complying all regulatory requirements. Good Manufacturing Practices and complying all regulatory requirements.

While doing so we shall keep in mind safety of our employees, all work processes as well as our While doing so we shall keep in mind safety of our employees, all work processes as well as our natural environment. natural environment.

The company shall manufacture products of high quality.The company shall manufacture products of high quality.

We consider our human resources as one of the biggest asset. Our qualified and trained staff is We consider our human resources as one of the biggest asset. Our qualified and trained staff is provided constant training to upgrade their knowledge and stay conversant with state of art provided constant training to upgrade their knowledge and stay conversant with state of art technology. technology.

We value motivation amongst our personnel as an important factor to make them more competent We value motivation amongst our personnel as an important factor to make them more competent and quality conscious. and quality conscious.

The company shall make available all the requisite measures and resources to achieve the above The company shall make available all the requisite measures and resources to achieve the above goals.goals.

Environment PolicyEnvironment Policy

It is policy to operate its business with a commitment for sound environmental management and It is policy to operate its business with a commitment for sound environmental management and with concern for the well-being of our common environment. Our goal is to ensure that company with concern for the well-being of our common environment. Our goal is to ensure that company facilities and operations are in compliance with local environmental standards. We believe that an facilities and operations are in compliance with local environmental standards. We believe that an appropriate balance can and should be achieved between environmental goals and economic health. appropriate balance can and should be achieved between environmental goals and economic health. This requires each Hemdeep organics pvt ltd employee to participate in and accept responsibility for This requires each Hemdeep organics pvt ltd employee to participate in and accept responsibility for achieving the following goals: achieving the following goals:

Operation of our facilities in an environmentally sound manner. Operation of our facilities in an environmentally sound manner.

Safe handling of production materials and byproducts. Safe handling of production materials and byproducts.

Conservation and recycling of raw materials and reduction in the amount of waste generated by the Conservation and recycling of raw materials and reduction in the amount of waste generated by the company’s production processes. company’s production processes.

Hemdeep organics pvt ltd will maintain compliance programs to inform and train employees in the Hemdeep organics pvt ltd will maintain compliance programs to inform and train employees in the performance of their duty to fulfill the company’s environmental policies. performance of their duty to fulfill the company’s environmental policies.

Hemdeep organics pvt ltd management will make environmental responsiveness and resource Hemdeep organics pvt ltd management will make environmental responsiveness and resource conservation an integral part of business management, and will support finding sound solutions to conservation an integral part of business management, and will support finding sound solutions to such environmental problems as may arise. such environmental problems as may arise.

Safety PolicySafety Policy

It is our policy that accident prevention shall be considered of primary It is our policy that accident prevention shall be considered of primary important in all phases of our operation and administration. It is the intention of important in all phases of our operation and administration. It is the intention of Manpower's top management to provide safe and healthy working conditions Manpower's top management to provide safe and healthy working conditions and to establish and insist upon safe practices at all times by all employees. and to establish and insist upon safe practices at all times by all employees.

We are committed to ensure that employees are assigned to work that is free of We are committed to ensure that employees are assigned to work that is free of unsafe working conditions and/or hazards. unsafe working conditions and/or hazards.

In order to meet these obligations, every Manpower staff member of Hemdeep In order to meet these obligations, every Manpower staff member of Hemdeep organics pvt ltd must make every reasonable effort and accept responsibility organics pvt ltd must make every reasonable effort and accept responsibility that employees are not exposed to those premises or work areas that are unsafe that employees are not exposed to those premises or work areas that are unsafe or present and undue hazard to our employees.or present and undue hazard to our employees.

VISION STATEMENT

To Develop and Manufacture Active Pharmaceutical Ingredients meeting current GMP standard and I.C.H. requirements. To Develop and Manufacture Active Pharmaceutical Ingredients meeting current GMP standard and I.C.H. requirements.

Mission Statement

“To develop cost effective quality Drugs and Drug intermediates for international market through innovative Research in Organic Synthesis and Analytical Sciences” To achieve sales target 50 caror per annum , filling the DMF in Japan, Europe & USA by 2017 .

Quality Management System

Quality Management system of the company ensures that the drugs manufactured by the company conforms to the standards, required by the current Good Manufacturing Practices. The company’s Quality Assurance Department strives to maintain the Product quality though critical evaluations, inspection and verification of the manufacturing process during the entire stages of manufacture. The Quality Assurance department is the in entrusted with the duties of overseeing all the operations right from the entry of the Raw Material/ packing materials, Manufacture of the intermediate products to final dispatch of the product to the market. During the entire manufacturing process all the section actively co-operate with the QA department to ensure adequate confidence in the Quality of the end product produced as per cGMP. The company’s Quality Control Department strives to maintain the product quality though In process analysis as well as finish product analysis of the product during the entire stages of manufacture.

Document System

Policy

Master Document

Protocols & Reports

Document Control

Process Equipments of various sizes and Process Equipments of various sizes and volumes:volumes:•Stainless Steel ReactorsStainless Steel Reactors•Glass Lined ReactorsGlass Lined Reactors•Centrifuges, Centrifuges, •Rubber Lined CentrifugesRubber Lined Centrifuges•Nutsche Filter,Pressure filter, Sparkler filterNutsche Filter,Pressure filter, Sparkler filter•Vacuum tray Dryer,Fluid bed dryer, Tray dryer Vacuum tray Dryer,Fluid bed dryer, Tray dryer etc..etc..

PLANT SP -01(Intermediate Manufacturing)

Equipment CAP. TOTAL CAP.SSR 1 KL TO 6.0 KL 24

GLR 1.6 KL TO 5.0 KL 22.1

UTILITY

Sr. No. Equipment Name Capacity

13 MS TANK 1500014 MS TANK 1500015 MS TANK 1500016 HDPE TANK 500017 HDPE TANK 500018 HDPE TANK 500019 HDPE TANK 500020 HDPE TANK 500021 HDPE TANK 500022 HDPE TANK 500023 HDPE TANK 500024 HDPE TANK 500025 HDPE TANK 200026 HDPE TANK 200027 HDPE TANK 200028 HDPE TANK 100029 HDPE TANK 100030 HDPE TANK 100031 HDPE TANK 1000032 RCC TANK 40000

UTILITY

Quality Control EquipmentsQuality Control Equipments1.1.Analytical BalanceAnalytical Balance

2.2.Karl Fischer TitratorKarl Fischer Titrator

3.3.Melting Point ApparatusMelting Point Apparatus

4.4.pH meterpH meter

5.5.Muffle FurnaceMuffle Furnace

6.6.UV Chamber UV Chamber

7.7.TLC chamberTLC chamber

8.8.HPLCHPLC

9.9.GC With Head SpaceGC With Head Space

10.10.Ultra Sonic Bath etc…Ultra Sonic Bath etc…

11

LIST OF QC EQUIPMENT

Sr. No. Instrument Name Id. No. Make Model

1 TLC CHAMBER TLC-QC-001 JAY LAB - 

2 KARL FISCHER TITRATOR KFT-QC-001 ANALAB AQA-CAL3 HOT PLATE HP-QC-001 ELTEK M 3 D4 HOT AIR OVEN HAO-QC-001 JAY LAB - 5 U.V. CABINATE UVC-QC-001 JAY LAB  -6 MUFFEL FURNACE MUF-QC-001 JAY LAB - 7 DIGITAL PH METER PHM-QC-002 TOSHWIN DP-505

8 MELTING POINT APPARTUS MPA-QC-001 VEEGO VMP-D

9 ANALYTICAL BALANCE BAL-QC-001 METTLER TOLEDO MS105DU

10 GAS CHROMATOGRAPH GC-QC-001 THERMO SCIENTIFIC CERES 800 PLUS11 HPLC HPLC-QC-001 SHIMADZU LC-2010 CHT12 DESICATOR DES-QC-001 BOROSIL -13 ULTRASONIC BATH USB-QC-001 Glasschem -

14 HUMIDITY CHAMBER STB-QC-001 MACK PHARMA MK-20 H

15 HUMIDITY CHAMBER STB -QC-001 MACK PHARMA MK-20-H16 STABILISER STBI-QC-001 ABC POWER SYSTEM SERVO SARTHI17 UPS UPS-QC-001 UTL SWI 15 EOU18 VACCUM OVEN VCO-QC-001 PARNASHA ENG. - 19 U.V SPECTRASCEAN UVS-QC-001 THERMO SCIENTIFIC UV-2700

20 HEAD SPACE (GC) HPGC-QC-001 THERMO SCIENTIFIC HS-50

21 Infrared IR-QC-001 - HS-50

L.M.GAMI COMPANY HEAD

Head Business

Development K.L. Patel

Head Production

K l patel

Head QCR.N.Patel

Head Engineering Lalit Gami

Head – QAKamlesh gami

Head Store & AccountTajesh kapadiya-Ankur Kansara

QA Officer -Kalpesh Patel

–Ami Patel AssistantsEngineerA.R.Sinde

Bhusan Girase

Production Officer--S.Patil

--Bimal Singh

TechniciansOperator--Shailesh Vasava--Ranjit Chavda

-- Mahendra thoke

Workers

KAMLESH GAMI

QC Officer

-Kailash Patel -Kitri Sinde - Kinjal Patel

Workers

Workers

Head R & DDr.Piyush patel

QA Chemist -Sabina Nanabava–Deepika Pandey

No.

SectionAsstManagers/Executives/Officers

Chemists/ Clerks

Operators SkilledWorkers

UnskilledWorkers

1. Admn.& Personnel 01 01 -- 01 01

2. Production 04 02 03 12 --

3. QA 02 02 -- 01 --

4. QC 02 03 -- 01 --

5. Utility & Eng. 02 -- 01 02 --

6. R&D 01 01 -- 01 --

7. Stores 01 01 -- -- 02

8. House keeping -- -- -- -- 04

MAN POWER UTILIZATION FOR EACH DEPARTMENT

Quality Control DepartmentQuality Control Department1.1.Quality Control Department:Quality Control Department:

2.2.Qualified and Trained PersonnelQualified and Trained Personnel

3.3.Basic Equipments available with all measuring instrument in Basic Equipments available with all measuring instrument in calibration Statuscalibration Status

4.4.Operations performed by following SOPsOperations performed by following SOPs

5.5.Specifications and Analytical Procedures as per customer Specifications and Analytical Procedures as per customer requirements and Pharmacopoeiarequirements and Pharmacopoeia

6.6.Reference Standards, working standards as per product Reference Standards, working standards as per product requirementsrequirements

Flow of Processing Activities

SAMPLE ANALYSED BY QC

APPROVED RAW MATERIALS

REQUISITION FROM PRODUCTION

DISPENSING

PROCESSINGACCORDING TO

MASTER PRODUCTION & CONTROL RECORD

REVIEW OF ANALYTICAL RECORD BY QA

REVIEW OF BATCH PRODUCTION & CONTROL

RECORD BY QA

Q.A. RELEASE

TRANSFER TO FGS

DISPATCH FOR SALE

NOT RELEASE

FURTHER ACTION BASED ON INVESTIGATION & QA

DIRECTIVE

Raw Material Control

Receive RM

Quarantine (Yellow)

Notification to QC through GIM

Sampling

Under Test (Yellow)

Analysis

‘Sampled’ Label

Approved (Green)

Certificate of Analysis

Rejected (Red)

Production DepartmentProduction Department1.1.Qualified and Trained PersonnelQualified and Trained Personnel

2.2.Adequate Space Adequate Space

3.3.Process Equipments as per the type of Reaction and usageProcess Equipments as per the type of Reaction and usage

4.4.Batch Manufacturing RecordsBatch Manufacturing Records

5.5.Equipment Status BoardsEquipment Status Boards

6.6.Equipment Cleaning as per sop Equipment Cleaning as per sop

7.7.Equipment Log BookEquipment Log Book

8.8.In-process Control Testing In-houseIn-process Control Testing In-house

9.9.House keeping and temperature humidity maintaining log bookHouse keeping and temperature humidity maintaining log book

Materials DepartmentMaterials Department1.1. Procured from Approved Vendors Procured from Approved Vendors

2.2. Identification of Components Identification of Components

3.3. FIFO SystemFIFO System

4.4. Only Approved Materials used for manufacturingOnly Approved Materials used for manufacturing

5.5. Quality StatusQuality Status

6.6. Storage of Finished ProductsStorage of Finished Products

7.7. Distribution of QA released ProductsDistribution of QA released Products

8.8.Separate area for sampling and dispensing of raw Separate area for sampling and dispensing of raw materialmaterial

Sr. No. Intermediate Name01 N-Sulfamyl -3-Chloropropionamidine Hydrochloride (IF)

02Diamino Methylene Amino (1- Amino-1-Iminomethylene) Thiomethyl-(Thiazole Dihydrochloride) ITU

03 Famotidine Crude04 Polyallylamine HCl solution (Intermediate of Sevelamar Carbonate)05 SULPHONAMIDE OF GLIMIPRIDE 06 5 –EHTYL PYRIDINE 2 ETHANOL( INTERMEDIATE OF PIOGLITAZONE HCL 07 2 ETHYL BENZOFURANE (2 ETHYL QUMARONE) INTERMEDIATE OF BENZBROMANONE 08

List of Intermediates

List of API

Sr. No. Product Name

01 Famotidine-EP/BP/USP/IP

02 Sevelamer Hydrochloride

03 Sevelamer Carbonate

04 GLIMEPIRIDE EP/BP/USP/IP

05 ADAPLINE

06 TALMISTATAN

07 CITRAZINE EP/IP/BP

08 FRUSAMIDE IP/BP/EP/USP

09 BENZBROMANONE JP/EP

10 BENZARONE

11 SITAGLIPTAN

Powder Processing:Powder Processing:

1.1.In Clean EnvironmentIn Clean Environment

2.2.One Product manufactured at a timeOne Product manufactured at a time

3.3.Hygienic Conditions maintained.Hygienic Conditions maintained.

4.4.No scope for cross contaminationNo scope for cross contamination

1.1.

API MANUFACTURING API MANUFACTURING

API MFG. GROUND FLOORAPI MFG. GROUND FLOOR

PPA AREA PPA AREA

CENTRIFUGE CENTRIFUGE

MILLING ROOMMILLING ROOM

INPROCESS QC WET LABINPROCESS QC WET LAB

INSTRUMENT ROOM QCINSTRUMENT ROOM QC

INSTRUMENT QCINSTRUMENT QC

INSTRUMENT QCINSTRUMENT QC

PLANT LAYOUT

GIDC WATER

40 KL RCC UG TANK

Over head HDPE tank

Strong Cation Exchanger Activated carbon filter

Strong Cation Exchanger

Strong anion exchanger

Mixed bed Exchanger

5 micron cartridge filter

D.M.Water Storage 4000 L SS tank, Jacketed for steam heating & cooling facility

0.2 Micron Cartridge Filter

Manufacturing area DM water Diaphragm outletSP1,SP2,SP3,SP4,SP5,SP6

Sampling Port (Raw Water)

HCl for resin Activation

Sodium Hydroxide SolutionFor resin Activation

Acid & CausticFor resin Activation

Sampling Port AfterCation & Anion Exchanger

Sampling Port(D.M. Water)

Vent filter0.01 micron

Steam for Heating to NLT 80° c

Sampling Port for DMWater After Tank

Sampling Port DM Water after filter

Samples from outlets (

D.M.WATER SYSTEM

Mutigrade Sand Filter

LIST OF CUSTOMER

NAME COUNTRY SUN PHARMACEITICALS INDIAZELTACK LBS INDIAZYDUS CADILA INDIA CADILA PHARMA INDIA ABORTS LAB INDIA FERTAX LABS PAKISTAN GENOMI PHARMA PAKISTAN PDH LABS PAKISTAN GELANE PHARMA BRAZILNOVARTIES PAKISTAN CHEMO GROUP SPAIN UQIPHA PHARMA SPAIN IPCA LAB INDIA Dr.Reddy lab IndiaSPMC SRILANKAHetro drugs pvt ltd INDIAMylan ltd INDIAArti drugs INDIA

Our Strength

• Qualified and Dedicated Team• Expertise of personnel in their field• Interdependent to each other• Past proven track record of achievements

Hemdeep organics pvt ltd has a GMP, FDA approved facility for the manufacture of APIs, which consists of MS Glass Lined Reactors, SS Reactors, Crystallisers, Certrifuges and Dryers. The API processing area is designed under regulations of Clean Room Concept, with Air Handling Systems and other regulations.

The manufacturing is supported by an In - process Control Laboratory to check and ensure the smooth running of unit operations. There is a full-fledged maintenance team for Civil, Mechanical, Electrical and Instruments. The team ensures systems validation at regular intervals.

Name of the firm: Hemdeep organics pvt ltd Address of Works : Plot No.3801/2

GIDC Estate ANKLESHWAR - 393002 BHARUCH-390002 INDIATelephone : 91-2646-224315 /09824114578/09998689897 Fax : 91-2646-226676 email :

hemdeeporganics@yahoo.com/info@hemdeeporganic.com

THANKS FOR YOUR THANKS FOR YOUR KIND ATTENTION!KIND ATTENTION!