Lexington
Our Lexington, 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.
Location Address:
Piramal Pharma Solutions Inc., 1500 Bull Lea Road, Suite 250, Lexington, KY 40511
Contact: 859-977-8600
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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
