Milestones are great, whether they come in the form of payments or, in the case of Cook Pharmica, the first FDA approval to manufacture commercially.
Catching up with some of its competitors, the contract development and manufacturing company says the FDA in February inspected the new vial fill finish line, freeze-drying capabilities and facility-wide quality systems at its plant in Bloomington, IN, and has now given the plant the thumbs-up. "This FDA decision marks a very important milestone for our company," says Tedd Green, president of Cook Pharmica.
Based on experience, the company says it expects the FDA approval is a precursor to getting approval to seek similar approvals to manufacture drugs for overseas markets.
The $200 million, 900,000-square-foot plant in Bloomington has vial and prefilled syringe manufacturing lines under barrier isolation, as well as secondary packaging. It can fill up to 15 million vials and 70 million prefilled syringes a year. The company has about 400 employees.
Fill finish has become a hot area in the contract manufacturing arena, with a number of companies expanding lines.
- here's the press release