Pharmaceutical excipient suppliers and large pharmaceutical companies must work more closely together to reduce the costs of drugs, promote innovation and ensure compliance with the new regulatory environment for excipients taking shape in Europe, delegates at the International Pharmaceutical Excipients Council (IPEC) Europe Seminar 2007, held earlier this year in Cannes, France, have heard.
Drug firms are constantly in search of new dosage form specifications to ensure their desired clinical effect is not compromised. As a result, the selection of new excipients is increasingly driven by patient need as well as process capability.
However, it was noted at the conference, as new legal requirements for Good Manufacturing Practice (GMP) in the production of certain excipients are introduced in the European Union (Marketletter March 27, 2006), suppliers will be required to offer these products made to the similar GMP principles as active pharmaceutical ingredients (APIs).
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