Cook Pharmica Receives an Additional Commercial Approval from US Food and Drug Administration
BLOOMINGTON, Ind. – March 25, 2013 – Cook Pharmica, which develops and manufactures pharmaceutical and biopharmaceutical products on a contract basis, recently received more good news from the Food and Drug Administration (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 the FDA has shown in our facilities by waiving 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.
For patients in need, the approval of this drug product will help fill a void that resulted from a national shortage of a product currently listed on the FDA’s Drug Shortage Index. Green added, “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 that are 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.