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,