Sr. No. |
Client |
Category |
DMM Scope of Service |
| 1 | Sandoz India, Kalwe, Phase 1 Thane |
OSD Cap: 2 billion units Plant Approved by EU, US FDA, MCC & TGA |
|
| 2 | Wockhardt Ltd, Aurangabad, India |
Biotech Injectables and |
|
| 3 | Dr Reddy’s Hyderabad, India |
Oncology API plant |
|
| 4 | Shreya Biotech Ltd, (now SciGen India Ltd), Pune, India |
Mammalian Cell Culture and bacterial fermentation API facility |
|
| 5 | KAPL, Bangalore, India |
Small Volume Parenterals (SVPs) |
|
| 6 | Rubamin Pharma, Baroda, India |
High potency API facility |
|
| 7 | Aristo Pharma, Baddi, India |
Oral solid dosage forms, Oral Liquids and Soft gel capsule plant at Baddi, HP, India |
|
| 8 | Aristo Pharma, Baddi |
Cephalosporins Small Volume Parenteral facility |
|
| 9 | Nicholas Piramal, Baddi, HP, India |
Oral solid dosage forms, Oral Liquids and Soft gel capsules |
|
| 10 | Nicholas Piramal, Baddi, HP, India |
LVP – Greenfield Facility |
|
| 11 | Zenotech Labs, Hyderabad, India |
Biotech API and formulations for mammalian cell culture and bacterial fermentation products |
|
| 12 | Sandoz India, Navi Mumbai, India |
Carbapenem APIs and sterile powder filling facility (USFDA APPROVAL) |
|
| 13 | Wockhardt Ltd, Shendra, Aurangabad, India |
Injectables facility |
|
| 14 | Erica Pharma, Goa, India |
Oral solid dosage forms facility |
|
| 15 | Sandoz India Ltd, Phase 2 Kalwe |
Oral solid dosage forms. Approved by Sandoz Global, US FDA, EU, TGA & MCC |
|
| 16 | Nicholas Piramal, Mahad, India |
Renovation of oral solid dosage forms Facility |
|
| 17 | Nicholas Piramal, Hyderabad, India |
Local anesthetics |
|
| 18 | Nicholas Piramal, Pithampur, India |
Renovation of oral solid dosage forms facility |
|
| 19 | Erica Pharma, Goa India | External Preparations facility |
|
| 20 | Shreya Biotech Pvt. Ltd. Pune, India. | Validation of multiproduct biotech facility jointly with M/s Sheppard Process UK |
|
| 21 | Biofarm, Romania |
Qualification of Process Equipments |
|
Sr. No. |
Client |
Category |
TPPL Scope of Services |
| 1 | Dr Reddy’s Laboratories Ltd (DRL), Hyderabad | Oral Solid Dosage Forms Facility for Export (SEZ) in Vizag (USFDA/EU APPROVAL) |
|
| 2 | Getz Pharma Research, Mumbai, India Aurangabad, India |
CRO unit with formulations R&D, Analytical R&D, Liquid Injectables for general & Cytotoxic products, and Pilot plant for formulations. |
|
| 3 | Sai Advantium Pharma Limited, Pune, Maharashtra | Formulations Research and Development Facility |
|
| 4 | RPG Life Sciences | API Facility in Navi Mumbai Oral Solid Dosage Forms Facility in Ankleshwar, Gujarat |
|
| 5 | Hebei Changshan Biochemical Pharmaceutical Co Ltd, China | API/Formulations facility in Hebei Changshan |
|
| 6 | Crossland Laboratories Jejuri | Secondary Formulations Manufacturing (Tablets, Capsules, Oral Liquids, Creams and Ointments) Facility Jejuri, Maharashtra |
|
| 7 | Natco Pharma, Hyderabad, India |
Oncological Injectables |
|
| 8 | Incepta Pharma, Dhaka, Bangladesh |
Oral Solid dosage |
|
| 9 | Nirma Limited, Ahmedabad, Gujarat | Injections and Devices Manufacturing Facility |
|
| 10 | GSK Ltd., Nasik | Oral Solid Dosage Forms Facility- Brownfield |
|
| 11 | Rubicon Research, Mumbai, India |
CRO unit: formulation development and mfg. unit (USFDA/EU APPROVAL) |
|
| 12 | Arvind Remedies Ltd., Chennai | OSDs. Liquid Orals, Ointments and Creams, Liquid Injectables, Lyophilized Injectables and Soft Gelatine Capsules |
|
| 13 | Sanovel, Istanbul, Turkey | Oncological: OSD Liquid Vials Lyophilised Vials (EU APPROVAL) |
|
| 14 | Vivimed Laboratories Ltd., Hyderabad | Oral Solid Dosage Forms Manufacturing Facility |
|
| 15 | Span Diagnostics Ltd, Surat | BSL 2 and BSL 3 Laboratories for Diagnostics |
|
| 16 | Sri Krishna Pharmaceuticals Ltd. (SKPL), Hyderabad | Granulations (ready for compression) Manufacturing Facility (USFDA APPROVAL) |
|
| 17 | Getz Pharma, Karachi, Pakistan | Oral Solid Dosage General liquid & lyophilised injections Cephalosporin’s OSD Cephalosporin’s Powder Injections |
|
| 18 | Rubicon Research, Mumbai, India | CRO unit: formulation development and mfg. unit | Cleaning Validation –
|
| 19 | Zydus Nycomed, Navi Mumbai | GMP training |
|
| 20 | RPG Life Sciences | API Facility in Navi Mumbai Oral Solid Dosage Forms Facility in Ankleshwar, Gujarat |
|
| 21 | Bilcare Ltd., Shiroli, Pune | Films and Foils Mfg. Facility |
|
Sr. No. |
Client |
Category |
Biopharmax Scope of Services |
| 1 | Unimark Ltd. Ahmedabad |
Sterile API bulk and fill-finish plant- Phase-I and II |
Qualification of –
|
| 2 | SciGen, Pune |
Biotech API Plant for Insulin | Qualification of –
|
| 3 | Abbott Healthcare, Baddi |
Process Skids |
Qualification of
|
| 4 | Dr Reddy’s Laboratories, Hyderabad |
HVAC Retrofit for FTO-1 facility |
|
| 5 | Bharat Serums and Vaccines, Ambernath |
Hormones Secondary Formulations Facility |
|
| 6 | Panacea Biotech, Lalru facility |
Vaccine Manufacturing Facility |
|
| 7 | Panacea Biotech, Baddi facility | Multy Vaccine Manufacturing Facility |
|
| 8 | Sovereign Pharma Daman |
Injectable Facility |
|
| 9 | Dr. Reddy’s Laboratories, Hyderabad |
OSD Facility FTO |
|
| 10 | SciGen Pune |
QC labs | Qualification of-
|
| 11 | Jayco Specialities Pvt. Ltd., Dahisar, Mumbai | Steroids and other Potent APIs manufacturing Facility |
|
Sr. No. |
Client |
Category |
Proficient Scope of Services |
| 1 | ACI, Bangladesh | Ophthalmics manufacturing facility (Sandoz Bangladesh Products) | Qualification of-
|
| 2 | Encore, Aurangabad | Oral Solid Dosage, Liquid Orals, Creams and Ointments Manufacturing Facility |
Retrospective Qualification:
|
| 3 | Ranbaxy laboratories, Dewas | Sterile Carbapenems API Mfg. plant |
|
| 4 | Insight Systems, Pune | Public GMP Training Programs | Topics covered:
|
| 5 | Abbott, Baddi | OSD Facility Expansion | Qualification of -
|
| 6 | Hospira, Vishakhapatnam | OSD facility Greenfield | Qualification of -
|
| 7 | GSK, Nashik | Oral Solid Dosage Forms Facility Renovation Plan |
|
| 8 | Bilcare, Pune | Primary packaging materials (Films and Foils) Mfg. Facility |
|
| 9 | Span Diagnostics Ltd, Surat | Existing Facility for In Vitro Diagnostic (IVD) Products Manufacturing |
|
| 10 | Arnita Consultants, Mumbai, India |
Iranian Client’s Oncological Oral Solid Dosage Forms Facility at Tehran |
|
| 11 | Sharangdhar Pharma, Pune, India |
Ayurvedic Oral Solid Dosage Forms Mfg. Facility – Greenfield |
|
| 12 | Systacare Remedies, Amritsar, India | Facility Upgradation |
|
| 13 | Dr Reddy’s Laboratories Ltd., Hyderabad | Gap Assessment of the HVAC systems at the manufacturing Site |
|
| 14 | Kind Healthcare, Pune | New Oral Solid Dosage Forms Facility |
|
| 15 | Saham Pharma Co. Morocco | New Small Volume Parenterals (SVP) Manufacturing Facility (Brown Field Project) (EU APPROVAL) |
|
| 16 | Saham Pharma Co., Morocco | New Large Volume Parenterals (LVP) Manufacturing Facility (Green Field Project) (EU APPROVAL) |
|
| 17 | Healthcare Pharma Ltd., Dhaka, Bangladesh | Non-Contraceptive Hormones – Multi formulations - OSD, Dermatologicals (Creams, Ointments, transdermal patches), Injectables (Ampoules, Liquid Vials, dry Powder vials, Prefilled Syringes, Ophthalmic preparations - facility | Facility Design review -
|
| 18 | East Trading and Manufacturing Company Limited, Dar Es Salam, Tanzania | General OSD formulations facility |
|
| 19 | Healthcare Pharma Ltd., Dhaka, Bangladesh | HVAC of OSD Facility |
|
| 20 | Healthcare Pharma Ltd., Dhaka, Bangladesh | Validation |
|
| 21 | RV Lifesciences, Aurangabad | Upgradation of OSD facility (Unit 1) (Project abandoned and project started at new site) |
|
| 22 | RV Lifesciences, Aurangabad | Greenfield of OSD facility (Unit 3) |
|
| 23 | Hi Tech Biosciences (I) Pvt Ltd., Pune (Under negotiation) | Probiotics, Nutraceuticals, Bio catalysis |
|
Milind Jog: (M Pharm) – C E O and SME Facility Design
Dr Abhay Walvekar: (M Pharm, PhD), Associate Director, Q.A.
Suresh Didmishe: (BE Mech. and BEE certified Energy Auditor) – SME- HVAC and Utilities
Mahesh Hasure (PRV Engineers) (Associate): Electrical Systems Design Expert
Dr Prasad Patwardhan: (BIE, PhD), SME – Computer System Validation (CSV) and Industrial Safety
Sarang Didmishe: (BE Mech. and BEE certified Energy Auditor) – Energy Efficient HVAC Systems design.
Vishwas Joshi: (DME) – HVAC and Utilities Site Execution
Rushikesh Jog: (BE Mech): HVAC, AutoCAD and Revit, Documentation
Deepak Inamdar: (B Pharm) - Director, Sterile Processes
