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API industry is facing serious headwinds that require re-strategizing business models

peter-werthThis week, we bring you another interesting interview with Peter J. Werth, President and Chief Executive Officer of ChemWerth, a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company providing current Good Manufacturing Practices (cGMP) quality APIs to the regulated markets. Werth talks about how complexities have increased in the last one year wherein the conversation on compliance has evolved from strictly GMP processes to data integrity and now Environmental Health and Safety (EHS). With the US Food and Drug Administration (FDA) publishing research for free, it is also becoming harder for generic manufacturers to find new products. Moreover, increasing costs mandate that API manufacturers put more efforts in product development so that the time to approval is considerably reduced. In light of these new challenges, Werth discusses the high standards and goals being set by his organization.

Read the interview on pharmacompass.com