Spotlight on Piramal Pharma Solutions, USA

Taking a closer look at the company's facility in Lexington, KY USA

Our Lexington, KY USA facility is a USFDA and PMDA 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.

Specialised 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

Location address:

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

Contact: +1 859-977-8600

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