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Cook Pharmica receives milestone FDA approval for commercial filling line

Cook Pharmica receives milestone FDA approval for commercial filling line
Cook Pharmica vial filling line


Cook Pharmica vial filling lineBiotech Week (July 3, 2012 11:01 PM)

 

By a News Reporter-Staff News Editor at Biotech Week

 

Company executives noted that the FDA's approval of its vial filling line and lyophilization (freeze-drying) capabilities has already generated widespread industry interest in its full manufacturing and packaging capabilities, with inquiries coming from many leading biopharmaceutical companies. The rigorous preapproval inspection is a prerequisite for commercial manufacturing of clients' drug product (see also FDA Actions).

 

"This approval demonstrates Cook Pharmica's ability and commitment to manufacture high-quality drug products within the FDA's stringent regulatory standards and practices. Everyone at Cook Pharmica is very pleased to have the opportunity and responsibility to ensure that we deliver a dependable commercial drug-product supply for our clients and ultimately to patients," Green said.

 

The parenteral manufacturing business unit of Cook Pharmica contains both vial and prefilled syringe manufacturing lines under barrier isolation, as well as secondary packaging to prepare products for distribution.

 

Capable of filling 15 million vials and 70 million prefilled syringes annually, Cook Pharmica's assets are available to fill the shortage of domestic drug product manufacturing in the United States and support federal efforts to eliminate dangerous drug shortages domestically. Based on other client projects at Cook Pharmica, the company expects to receive similar approvals to manufacture drug products for overseas markets as well.

 

About Cook Pharmica LLC

Cook Pharmica is an integrated contract development and manufacturing organization that provides the pharmaceutical and biopharmaceutical industries with drug substance manufacturing from mammalian cell culture; analytical and formulation development; parenteral manufacturing in vials and prefilled syringes; lyophilization; and secondary packaging.

 

Operating with more than 400 employees in a 900,000-square-foot, $200 million facility in Bloomington, Ind., Cook Pharmica's mission is to consolidate and simplify clients' contract manufacturing into one source at one location.

 

Founded in 2004, Cook Pharmica, the biopharmaceutical manufacturing division of Cook Medical, is a privately held, wholly owned subsidiary of parent company Cook Group. For more information, visit www.cookpharmica.com. Follow Cook Medical on Twitter @CookMedicalPR.

 

Keywords for this news article include: Drugs, Therapy, FDA Actions, Biopharmaceuticals, Investment and Finance.

 

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2012, NewsRx LLC

 

(c) 2012 Biotech Week via NewsRx.com

 

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