Cook Pharmica Receives Additional Approval From US FDA
Cook Pharmica, which develops and manufactures pharmaceutical and biopharmaceutical products on a contract basis, recently received more good news from the US FDA. The company earned another commercial approval from the FDA and did so with the FDA waiving the otherwise required pre-approval inspection.
“We are grateful for the confidence shown in our facilities by the waiving of the inspection and are especially pleased that the quick approval will allow this drug to make it to patients in need. We will continue to work with the FDA to ensure that future clients experience the same efficient approval process,” said Tedd Green, President of Cook Pharmica.
The approval of this drug product will help fill a void for patients in need, which resulted from a known, national drug shortage of a product currently listed on the FDA’s Drug Shortage Index. Added Green, “We will continue to seek productive ways to support the biopharmaceutical industry, the FDA, and ultimately patients by using our contract manufacturing assets to help increase the supply of sterile injectable products in shortage.” Fifteen million vials and 70 million syringes can be filled each year by the state-of-the-art manufacturing lines at the technologically advanced facility.
Cook Pharmica is an integrated contract development and manufacturing organization providing 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 450 employees in a 900,000-sq-ft, $200-million facility in Bloomington, IN, 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.
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