FINISHED DOSAGE MANUFACTURING

We manufacture, supply and distribute commercial formulations for oral solids from our Sellersville, Morpeth and Pithampur facilities. Apart from OSDs we also provide liquids, creams and ointments from our Sellersville facility and sterile injectables from our Lexington site. We are a trusted manufacturing partner to leading biotech, small and virtual pharmaceutical companies as well as mid-size and big pharmaceutical companies. Our scalability is defined from pilot level to commercial level to serve customers at every stage of drug lifecycle from manufacturing perspective. We leverage our global network of manufacturing sites and are successful in supplying commercial formulations to the US, Europe, Japan and Asia Pacific markets.

Sterile Injectables

Our sterile injectable manufacturing facility offers cGMP manufacturing of a wide range of injectable products. We combine individualized service with unparalleled speed and flexibility to manufacture parenteral drug products in liquid and lyophilized dosage forms. Unique mobile isolator technology ensures product containment for potent and cytotoxic compound products while providing an aseptic manufacturing environment.

Product Experience

  • Sterile Solutions and Suspensions (Aqueous/Non-aqueous)
  • In-situ Salt Formations
  • Nanoparticles and Liposomes
  • Stable emulsions
  • Lyophilized Products

Featured Services

  • Process Development and Optimization
  • Clinical and Commercial manufacturing of liquid and lyophilized formulations
  • Pre-Clinical to Phase III Manufacturing for:
    • Animal Safety/Toxicity Studies
    • Human Clinical Products
    • Veterinary Products
  • Development and manufacture of potent drug products
  • Pilot-Scale Manufacturing: Aseptic and Non-Aseptic
  • Sterile and ADC Fill/Finish
    • Vials from 2 – 50 mL
    • Dispensing volume as low as 0.5 mL up to 50 mL
  • Parenteral Liquids, creams and ointments
    • Vials from 2 – 50 mL
    • Dispensing volume as low as 0.5 mL up to 50 mL
  • Terminal Sterilization

Salient Features

  • Class C (Class 10,000) formulation room
  • Class A (Class 100) biological safety cabinets in each formulation room