Spotlight on Piramal Pharma Solutions, USA

30-Jun-2021

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