Specializing in complex formulations including liposomal products, Enzon provides turnkey manufacturing services including formulation, fill & finish, packaging and testing of parenteral products including dual chamber vials. Our staff has an average of 20 years experience manufacturing complex sterile formulations. From clinical to commercial products we provide the services you require, including :
- Raw material/API testing
- Formulation and scale up
- Large scale aseptic bulk manufacturing
- Small scale bulk manufacturing
- Aseptic vial filling
- Full analytical chemistry and microbiological testing
- ICH Stability Studies
Located in Indianapolis, Indiana, our fully integrated facility was commissioned and received FDA and MHRA approvals in 1997 following a comprehensive upgrade of mechanical systems, manufacturing equipment and quality systems. Since then, the site has been under the continuous scrutiny of Enzon’s quality unit and regularly receives satisfactory ratings from federal, local and international agencies and you, our partners.
The manufacturing area occupies approximately 12,000 of the 40,000 square feet building and operates as a cGMP small volume parenteral manufacturing facility. The quality control laboratories conduct both routine and specialized analytical testing, microbiology testing including sterility, endotoxin and ICH stability studies.
Enzon manufactures small volume parenteral products including small molecules and biologicals in batch sizes ranging from several Liters to 350 Liters. We fill in vials ranging from 2 mL to 50 mL.