Clinical Supplies

Clinical Supplies

Kemwell offers clinical manufacturing from lab-scale to commercial, in a wide range of pharmaceutical drug product dosage forms for both small molecules and large molecules. Our cGMP facilities in India manufacture products for clinical and commercial supplies in multiple markets, including North America, European and Asian markets.

Core Expertise:
  • cGMP manufacturing through phase I, II & III
    1. Solids
    2. Liquids
    3. Semi-solids
    4. Parenterals
    5. Biologics (proteins, monoclonal antibodies)
  • First-in-Man Supplies
    1. Powder/API in bottle
    2. Powder/API in capsule
  • Clinical packaging
    1. Bottles
    2. Blisters
    3. Tubes
    4. Sachets
    5. Vials
    6. Prefilled Syringes
    7. Wallet Cards

 

  • Labeling
    1. Flexible/User friendly software (CLAPS) for the labeling and management of blinded clinical trial supplies.
    2. CFR 21 part 11 compliant system
  • Comparator Development, including Over-Encapsulation
  • Placebo Manufacture
  • Cleaning Verification
  • QP Release (from Sweden for EU markets)
  • Dosage form development and blinding
  • Storage & Distribution
  • Returns, Reconciliation, and Destruction