We manufacture, supply and distribute commercial formulations from our facilities in UK and India for Oral Solids and Lexington, USA for Sterile Injectables. 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.

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Sterile Injectables

Our Sterile Manufacturing facility located in Lexington, Kentucky in the USA 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 within our 22,000 square foot state-of-the-art FDA approved sterile manufacturing facility ensures product containment for potent and cytotoxic compounds products while providing an aseptic manufacturing environment.

Product Experience

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

Our Services

  • Process Development & 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 Lyophilization
    • Vials from 2 – 50 mL
    • Dispensing volume as low as 0.5 mL up to 50 mL
  • Terminal Sterilization

Equipment

  • Finn Aqua (Steris) autoclave (38 square feet)
  • Depyrogenation oven (48 square feet)
  • Bosch vial filler with capper (maximum output of 900 vials/hour)
  • Chase Logeman Filler with Capper (30 vials/minute)
  • Steriline filler (100 vials/minute)
  • Bausch and Stroebel filler (100 vials/minute)
  • Hull lyophilizer (48 square feet)

Systems

  • Water for Injection Hot Loop Distribution System
  • Clean Steam Generation and Distribution
  • Medical Grade Air and Nitrogen Distribution Systems
  • Refrigerated and Ultra Low Temperature (ULT) Storage
  • Emergency Power Generator

Features

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

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