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Hyderabad-based Dr Reddy's Laboratories (DRL) informed the stock exchanges that the US drug regulator has completed the audit of active pharmaceutical ingredients (APIs) manufacturing plant at Srikakulam special economic zone in Andhra Pradesh with no observations.
If the US Food and Drugs Administration (FDA) finds any violation of the Food Drug and Cosmetic Act, it will issue Form 483 and the pharma company should respond to the observations with a corrective action plan and then implement that expeditiously.
The USFDA has recently issued Form 483 with two observations to DRL's another API facility at Srikakulam.
