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

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Georgina Davidson
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1 OVERVIEW

Manufacturer of a wide range of products across various therapeutic

2 COMPANY OVERVIEW Global Pharmatech started as a specialized Sterile Liquid Injection manufacturing company in 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).

3 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.

4 QUALITY POLICY 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.

5 APPROVALS WHO GMP: Valid up to NAFDAC: Approved in Sept 2014 DPM: GMP from Cote d Ivoire EU GMP compliant: Under Renewal ISO 9001:2008: Valid up to ISO 13485:2003: Valid up to Periodically audited by GSK, PMS Canada and our other customers.

6 IMPORTANT AUDITS - TRIGGERED Health Canada Audit 17 to 23 Sept 2015 EU GMP - Hungary (PICS) 11 to 15 Jan 2016 MOH- Malaysia (PICS) Q MCC South Africa SMF accepted Ethiopian Food, Medicine & Healthcare Administration & Control Authority (EFMHACA) awaiting audit schedule TGA / TFDA / NDA will be triggered soon

7 SITE LAYOUT

Deepak Vagale Finance & HR Mr. Hegde Production Mr. Chandran Engineering FR&D Mr. Raja G AR&D Mr.

8 ORGANIZATION STRUCTURE Mr. T. Thomas Chairman Dr. Bhaskar Krishna Managing Director 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 Engineering FR&D Mr. Raja G AR&D Mr. Karthik N Regulatory Mrs. Sindhu Hari Instrumentation Mrs. Sumathi Microbiology Mr. Shyam Quality Assurance Mr. Sethurajan G

9 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 SINDHU HARI DGM Business Development DGM Regulatory B.Sc., D. Pharm Business Development 20 Yrs. 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

10 EMPLOYEE STRENGTH Department Staff Workmen Total Quality Assurance Quality Control Production Stores and Distribution Technical, Engineering, and other support services, FR&D/AR&D, Regulatory Affairs TOTAL EMPLOYEES Total

11 RAW MATERIAL WAREHOUSE QUARANTINE (AMBIENT) 70 sq.mt (with multi level storage racks) QUARANTINE (BELOW 25 O C) 30 sq.mt (with multi level storage racks) APPROVED MATL (BELOW 25 O C) 130 sq.mt (with multi level storage racks)

12 SAMPLING AND DISPENSING SAMPLING DISPENSING Dedicated sampling booths and dispensing booths with RLAF under Class D area

13 AMPOULE LINE 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

14 VIAL 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

15 INSPECTION 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.

16 PACKING 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

17 FINISHED GOODS WAREHOUSE AMBIENT TEMPERATURE : Storage area of 125 sq.mt TEMPERATURE BELOW 25 O C : Storage area of 150 sq.mt

18 Air Handling Unit 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

19 Classification of Manufacturing Areas Grade-A (Filling) is provided by laminar airflow stations, HEPA of % 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 % and 0.3 micron with terminal HEPA of % efficiency is series Grade-C (Compounding): 20 micron, 10 micron, 5 micron, 0.3 micron plenum HEPA of % and 0.3 micron with terminal HEPA of % efficiency is series Grade-C (Washing): 20 micron, 10 micron, 5 micron with plenum HEPA of % efficiency

20 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

21 Raw Steam 2 MT briquette boiler 800 KG standby diesel boiler Utilities: Other 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)

22 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)

23 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.

24 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

25 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

26 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

27 STABILITY CHAMBERS 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

28 PRODUCT REGISTRATION PRODUCTS REGISTERED Product Promethazine Hcl 2 ml Ampoule Country Algeria 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

29 THANK YOU

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