Thursday, July 31, 2014

FDA raises concern over drug production process at India's Cadila

A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring By Abhishek Vishnoi and Zeba Siddiqui MUMBAI (Reuters) - India's Cadila Healthcare Ltd is responding to certain observations the U.S. Food and Drug Administration (FDA) made after conducting a "product specific" inspection of its Moraiya manufacturing plant, a company spokeswoman said on Thursday. Sources with direct knowledge told Reuters earlier that the FDA expressed concerns over the manufacturing process of at least one product at Cadila's Moraiya facility in the western Indian state of Gujarat. ANDA is an application drugmakers file with the FDA seeking approval to launch a new generic drug. There is no business impact from the FDA action and Cadila has not received any observations on the standard manufacturing practices at the Moraiya plant, the spokeswoman said.








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