Socma Pushes for Greater U.S. Oversight of Overseas API Production

Socma has asked the U.S. FDA to beef up inspections of foreign facilities manufacturing active pharmaceutical ingredients (APIs). Socma and the Bulk Pharmaceuticals Task Force submitted comments on an FDA advisory panel’s recent report “FDA Science and Mission at Risk,” which details the administration’s deficiencies and needed upgrades. Socma says that the report does not adequately address lax U.S. oversight of foreign facilities manufacturing API’s, although 80% of all API’s are manufactured overseas. FDA officials continue...

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