Drug substance & Drug Product facility inspected and approved by Qualified Person from EU Drug substance & Drug Product facility inspected by MHRA and EU GMP certified
Drug Substance
Location
- Nerul, Navi Mumbai
Capabilities
- Fully functional State-of-the-art GMP facility for Biotherapeutics
- Capacity expansion to Commercial scale completed
- Preparation of material for clinical studies, API Generation and Commercial scale manufacture
- Facility is EU GMP and WHO GMP certified
Infrastructure
- Fully Automated Fermentors
- Tangential flow filtration systems for micro, dia and ultra-filtration
- Homogenisers
- Continuous Centrifugal Separator
- Protein Purification Systems (1ml/min to 3L/min flow rates)
Drug Product
Location
- Daman
Capabilities
- Manufacture of Liquid vials, lyophilised vials, opthalmic bottles and pre-filled syringes
- Facility has been approved by WHO GMP, MHRA, Canadian Health Authority and State FDA,