OVERVIEW

COMPANY OVERVIEW

Global Pharmatech started as a specialized Sterile Liquid Injection manufacturing company in 1996.

Manufacturer of a wide range of products across various therapeutic segments.

Total plant area of 5 acres is located in Hosur, Tamil Nadu (outskirts of Bangalore).

VISION

“To be recognized as a world class manufacturer of pharmaceutical formulations

and create value for our business partners and stakeholders through continuous

improvement and innovation to improve Quality of Life”.

We are committed to comply with customer requirements and with all applicable regulations,

and to ensuring product quality, safety and efficacy.

To achieve this goal, we shall maintain and continually improve the

effectiveness of our Quality Management System.

QUALITY POLICY

WHO GMP: Valid up to 31.12.2015

NAFDAC: Approved in Sept 2014

DPM: GMP from Cote d’Ivoire

EU GMP compliant: Under Renewal

ISO 9001:2008: Valid up to 28.05.2016

ISO 13485:2003: Valid up to 28.05.2016

Periodically audited by GSK, PMS Canada and our other customers.

APPROVALS

Health Canada Audit – 17 to 23 Sept 2015

EU GMP - Hungary (PICS) – 11 to 15 Jan 2016

MOH- Malaysia (PICS) – Q4 2015

MCC – South Africa – SMF accepted

Ethiopian Food, Medicine & Healthcare Administration & Control Authority (EFMHACA) – awaiting audit schedule

TGA / TFDA / NDA will be triggered soon

IMPORTANT AUDITS - TRIGGERED

SITE LAYOUT

Mr. T. Thomas

Chairman

Dr. Bhaskar Krishna

Managing Director

ORGANIZATION STRUCTURE

Operation Mr. Arul Prasadh

Quality operation Mr. Chezhian

Supply Chain Mr. Viswanathan R&D

Business Development Mr. Deepak Vagale

Finance & HR Mr. Hegde

Production Mr. Chandran

Instrumentation Mrs. Sumathi

Microbiology Mr. Shyam

Quality Assurance Mr. Sethurajan G

FR&D Mr. Raja G

AR&D Mr. Karthik N

Regulatory Mrs. Sindhu Hari

Engineering

MANAGEMENT TEAM

Name Designation Qualification Responsibility Experience

Dr. BHASKAR KRISHNA Managing Director PhD, MBA General Management 19 Yrs.

SHIVANANDA HEGDE Chief Finance Controller FCA, ACS Finance, Accounts & HR 16 Yrs.

S. ARUL PRASADH DGM Operation B.Pharm., MS Head of Production &

Engineering 17 Yrs.

S. CHEZHIAN DGM – Q.O. M.Sc. Quality Operation 20 Yrs.

A.VISWANATHAN DGM-Supply Chain B.Sc. MBA Supply Chain Management 25 Yrs.

DEEPAK VAGALE DGM – Business Development

B.Sc., D. Pharm Business Development 20 Yrs.

SINDHU HARI DGM – Regulatory B.Sc., Diploma in Regulatory

Regulatory Affairs 20 Yrs

G. RAJA Sr. Manager – FR&D B.Pharm., MS Formulation Department 14 Yrs.

N. KARTHIK Sr. Manager – AR&D M.Sc Analytical Development 9 Yrs

TOTAL EMPLOYEES- 221

Department Staff Workmen Total

Quality Assurance 15 01 16

Quality Control 24 03 27

Production 24 102 126

Stores and Distribution 10 04 14

Technical, Engineering, and other support services, FR&D/AR&D, Regulatory Affairs

28 25 53

Total 101 135 236

EMPLOYEE STRENGTH

QUARANTINE (AMBIENT) 70 sq.mt (with multi level storage racks)

QUARANTINE (BELOW 25O C) 30 sq.mt (with multi level storage racks)

APPROVED MATL (BELOW 25OC) 130 sq.mt (with multi level storage racks)

RAW MATERIAL WAREHOUSE

Dedicated sampling booths and dispensing booths with RLAF under Class D area

SAMPLING AND DISPENSING

SAMPLING DISPENSING

Integrated Washing, Sterilization, and Filling line

Terminal Sterilizer in place

Aseptically filtered with 0.2 micron filters

Fill volume: 1mL to 10mL

Batch size: 100 liters to 400 liters

Speed: 250 Ampoules/minute

Annual Capacity: 72 million Ampoules

AMPOULE LINE

Integrated Washing, Sterilization and Filling line

Aseptically filtered with 0.2 micron filters

Batch size: 100 liters to 400 liters

Fill volume: 2mL to 100mL

Speed:150 vials / minute

Annual Capacity: 36 million vials

VIAL LINE

100% visual inspection of all filled containers.

Visual inspection conducted manually and with semi automatic inspection machines by trained and qualified personnel by validated method.

Visual inspection designed to remove all

defective containers.

INSPECTION

CAPACITY Ampoules: 250,000 per shift

Vials: 100,000 per shift

BLISTER MACHINES Form Pack: 400 Ampoules / minute

Rapid Pack: 400 Ampoules / minute

PACKING Blisters and Vials manually packed in cartons

QUALITY In process check carried out to eliminate packing errors

PACKING

AMBIENT TEMPERATURE : Storage area of 125 sq.mt TEMPERATURE BELOW 25O C : Storage area of 150 sq.mt

FINISHED GOODS WAREHOUSE

• Total 22 AHUs to provide clean air as per criticality of the process

• Separate Air Handling Units with HEPA filters are installed at each processing room.

• Aseptic area temperature is maintained between 18°C to 25°C and Relative Humidity (RH) is maintained between 40% to 60%. Temperature of storage areas is maintained based on material or product requirements.

• The entire plant is maintained at a positive differential pressure with respect to the external atmosphere.

• A minimum pressure differential of 1.6mm/16 Pascal's is maintained between two different classified areas and positive pressure is maintained from critical to non critical rooms of the same classification

• All AHUs are designed to have sufficient air-changes with 10% fresh air intake during each cycle.

• Filling room Air Changes is NLT 70 ACPH

Air Handling Unit

• Grade-A (Filling) is provided by laminar airflow stations, HEPA of 99.999% efficiency and is surrounded by Grade-B

• Grade-B ( Back ground of Filling): 20 micron, 10 micron, 5 micron, 0.3 micron plenum HEPA of 99.997% and 0.3 micron with terminal HEPA of 99.999% efficiency is series

• Grade-C (Compounding): 20 micron, 10 micron, 5 micron, 0.3 micron plenum HEPA of 99.997% and 0.3 micron with terminal HEPA of 99.997% efficiency is series

• Grade-C (Washing): 20 micron, 10 micron, 5 micron with plenum HEPA of 99.997% efficiency

Classification of Manufacturing Areas

Utilities: Water System

• Purified Water – RO/EDI system

– Capacity: 5000 liters/hr

• Water for Injection (WFI) – Multi-column evaporator with continuous circulation loop with WFI at

> 80°C.

– Capacity: 1500 liters/hr

• Pure Steam – Capacity: 300 kilograms/hr

Utilities: Other

• Raw Steam – 2 MT briquette boiler

– 800 KG standby diesel boiler

• Electricity – Sanctioned load of 950 KVA supplied by State Electricity Board

– Full Diesel Generator backup (500 KVA, 380 KVA, 250 KVA)

• Cooling – 250 TR Vapour Absorption Machine

– Backup Screw Chillers (150 TR and 45 TR)

Utilities: Other

• Compressed Air – Capacity: 300 CFM

• Nitrogen – Capacity: 25 Nm3/hr

– Complies with EP and USP

• Effluent Treat Plant – Onsite Zero Liquid Discharge (ZLD)

– Sewage Treatment Plant (STP)

QUALITY

• Global Pharmatech’s strength is providing products of the highest quality.

• In keeping with the requirements of our customers, the quality assurance department adopts the best of procedures and practices.

• The plant is scrupulously operated through built-in rigorous Quality Assurance procedures, strict documentation and internal audits.

QUALITY CONTROL INSTRUMENTS

UV Spectrophotometer HPLC with Auto sampler Liquid Particle counter

Micro Balance IR Spectrophotometer Mini API Analyzer

Atomic Absorption Spectrophotometer (AAS)

RESEARCH AND DEVELOPMENT

• Formulation R&D

– Develop solution formulations in vials and ampoules

– Enhancing capability to develop emulsions, suspensions, and DEPO products

– Will acquire capability to develop lyophilization products

• Tech Transfer

– Experienced with good project management

• Analytical R&D

– Responsible for Method Development and validation

LYOPHILIZATION

• New Capability for Global Pharmatech

• To be constructed by incorporating part of Unit 1 into Unit 2 – Vial line: 200 vpm

– Lyo Chamber: 8.6 m2

• Expected to complete by next 15 to 18 months

Climatic Zone Zone Temperature Humidity

Real Time II 25 ºC ± 2 ºC 60% RH ± 5% RH

Real Time IV a 30 ºC ± 2 ºC 65% RH ± 5% RH

Real Time IV b 30 ºC ± 2 ºC 75% RH ± 5% RH

Real Time (under installation)

Cold Chain 5 ºC ± 3 ºC -

Accelerated - 40 ºC ± 2 ºC 75% RH ± 5% RH

STABILITY CHAMBERS

PRODUCTS REGISTERED

Product Country

Promethazine Hcl 2 mL Ampoule Algeria

PRODUCT REGISTRATION

PRODUCTS UNDER REGISTRATION

ASIA AFRICA LATAM

Philippines Nigeria, Cote d’Ivoire Dominican Republic

Vietnam South Africa, Namibia, Zambia Jamaica

Malaysia Togo, Burkina Faso, Senegal, Mali Peru

Myanmar Ethiopia, Kenya, Tanzania, Uganda

THANK YOU