Cook Pharmica recently received commercial approval from the FDA for a drug product and did so with the FDA waiving the otherwise required pre-approval inspection (PAI). Cook Pharmica is a pharma and biopharma CDMO.
According to a company statement, 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.
Tedd Green, president of Cook Pharmica, commented, “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.”
Mr. 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 in shortage.”