IPEC-Americas is the only worldwide pharmaceutical industry organization that has embraced harmonization of drug approval and pharmacopoeial standards for excipients as part of its mission. Also, at the present, IPEC-Americas is the only U.S. trade association actively working to bring about the free flow of safe, useful excipients to ensure safe and effective finished RX and OTC drug dosage forms in the international marketplace.
IPEC-Americas has dedicated itself and its resources to bring about the needed changes by working closely with the FDA, its counterparts in the ICH process, and through the Pharmacopeial Discussion Group.
How IPEC-Americas Is Different
Unlike PhRMA, GPhA, CHPA, and other U.S. industry associations whose primary focus is on the action of finished drugs and pharmacologically active ingredients and whose principal members are manufacturers and marketers of final pharmaceutical dosage forms, IPEC-Americas members also include firms that make bulk excipients that go into a finished drug product.
This unique partnership of makers and users of drug components works well in IPEC-Americas in part because of the relationship which frequently exists between international pharmaceutical marketers and their counterparts among multinational suppliers of excipients for global use. Often, the impetus to qualify an excipient for a new use in pharmaceuticals or in a new or different dosage form can lead to joint ventures between the producers and potential formulators for necessary testing & submission of data to U.S. and other national regulatory authorities. Cooperation, therefore, is based on the shared goal of both users and producers to qualify a single formulation for marketing in many countries.