FDA Approves Shanghai Ziyuan

Shanghai, China; Woodbridge, CT (Generics Bulletin): Chinese active pharmaceutical ingredient (API) manufacturer Shanghai Ziyuan has passed a facility inspection by the US Food and Drug Administration (FDA) with no deficiencies highlighted.

The FDA’s inspection was linked to Ziyuan’s drug master file (DMF) for fosphenytoin sodium, which it markets in the US through its local agent ChemWerth. According to ChemWerth, Ziyuan supplies about four-fifths of US demand for the epilepsy drug.

Noting that ChemWerth had been working with Ziyuan since before the Chinese firm got its first FDA approval for dobutamine API in 1993, the US-based agent’s president and chief executive officer Peter Werth said the two firms were currently working on developing isradipine, injectable-grade lincomycin and naftifine for the US and other regulated markets.

Acknowledging concerns about the quality of pharmaceutical exports from China, Werth stressed that ChemWerth had been working with the FDA in China for over 20 years, during which time the firm and its partners had been through approximately 100 inspections. “This experience helps ensure products coming from China, with ChemWerth as the agent, are of the highest quality in the world,” he insisted.

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