IPEC-Americas is a U.S. trade association whose members include finished drug manufacturers as well as excipient producers, distributors, and both companies and individuals that supply other specialized services to industry segments. Over 80 U.S. companies are IPEC-Americas members. IPEC-Americas brings together diverse stakeholders that share a common objective: Safe and effective production and use of excipients.
What We Do
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.
IPEC-Americas is part of a global federation, the IPEC Federation, that brings together excipient manufacturers, distributors and users from the U.S., Europe, Japan, China, and India to promote quality standards. Their partnership is key to worldwide excipient communication, harmonization, standards and safety.
Pharmacopoeial harmonization projects
IPEC committees and technical working parties from the global regions have developed and submitted proposed monographs for a number of excipients identified by the major compendia as priority candidates for harmonization. Some industry submissions have been recommended for acceptance by one or more committees of revision and others are under review by pharmcopoeial committees.
Currently, IPEC-Americas subcommittees are working to harmonize numerous important excipient materials that include several cellulose derivatives, gelatin, glycerin, magnesium stearate, the parabens, polyethylene glycol, the polyols, starches and titanium dioxide. Special working groups studying heavy metals-related issues and others that involve method validation also are active.
IPEC-Americas hosts various conferences and seminars relevant to anyone in the pharmaceutical manaufacturing or regulatory fields, including its annual ExcipientFest conference. As the need has arisen since its founding, IPEC-Americas has produced workshops and industry-wide conferences that address important regulatory affairs and compendial issues.
IPEC-Americas is the premier source for regulatory and guidance documents critical to the excipient industry. Reference materials and guides are available in the Document Depot .
Education and Training
The IPEC-Americas Excipient Learning Lab (ELL) offers high value educational opportunities by leveraging the industry knowledge and expertise of its members.
IPEC-Americas subject matter experts share knowledge on issues related to excipients including (but not limited to):
- Regulation and compliance with industry standards and expectations (globally, when possible);
- IPEC guidelines;
- Supplier qualification through audit and certification;
- Updates / reviews of current and emerging “hot topics” such as complying with FDASIA, IID, Atypical Actives, and GInAS;
- IPEC membership activities via committee projects
Academic outreach and excipient research (IPEC Foundation)
The IPEC-Americas Foundation encourages research and education in excipients, and awards prizes, scholarships and grants to further cutting edge advancement related to the field of excipients used in pharmaceuticals and biotech.