Lexington

Our Lexington, USA facility is a USFDA and PMDA Japan inspected, fully integrated site which offers analytical, formulation development, and manufacturing services facility with an emphasis on clinical trial to commercial-scale manufacturing of sterile liquid and lyophilized injectables.

Location Address:

Piramal Pharma Solutions Inc., 1500 Bull Lea Road, Suite 250, Lexington, KY 40511

Contact: 859-977-8600

Specialized Capabilities

  • Sterile & ADC Fill/Finish
  • Clinical scale and Commercial production of Sterile Injectables
  • Development and manufacture of potent drug products
  • Full-service microbiology laboratory testing of drug substances and products
  • Formulation Development
    • Lyophilized formulation development
    • In-situ salt formations
    • Sterile solutions, Nanoparticles, and Liposomes
    • Generic and innovative products

Featured Services

  • Two Grade C formulation rooms, each with a Class 100 laminar flow cabinet
  • Three fully contained automated filling lines, fill speeds up to 40 vials per minute
  • Sterile Solutions: 100,000 vials of 10mL or equivalent for 2–100 mL vials
  • Lyophilized products: 7,000 vials of 10mL equivalent for 2–100 mL vials
  • Non-sterile liquids or suspensions: 500L
  • Terminal sterilization: 5,000 vials of 10 mL or equivalent surface area

Salient Features

  • Registered with the FDA and the Commonwealth of Kentucky Board of Pharmacy for the manufacturing of pharmaceutical products
  • PMDA and Taiwan GMP Certificate
  • Mobile isolator technology
  • ISO Class 5 Environment
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