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Was issued in response to CGMP inspection at Tampa facility
August 10, 2017
By: Tim Wright
Editor-in-Chief, Contract Pharma
Aerie Pharmaceuticals says it has received notification by its contract drug product manufacturer that the contract manufacturer received a Complete Response Letter (CRL) from the U.S. FDA regarding the contract manufacturer’s New Drug Application (NDA) for one of their own product candidates manufactured at their Tampa, FL facility. According to the contract manufacturer, the CRL refers to a Current Good Manufacturing Practice (CGMP) inspection at the facility. The contract manufacturer has sta...
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