USFDA inspects Dr Reddy's Srikakulam SEZ unit
DSIJ Intelligence / 15 Apr 2017
The Hyderabad-based pharma major Dr Reddy's Laboratories (DRL) announced the completion of the audit and inspection of the active pharmaceutical ingredients (APIs) manufacturing plant at Srikakulam by the US Food and Drugs Administration (FDA).
The Hyderabad-based pharma major Dr Reddy's Laboratories (DRL) announced the completion of the audit and inspection of the active pharmaceutical ingredients (APIs) manufacturing plant at Srikakulam by the US Food and Drugs Administration (FDA).
In the inspection of the company's Srikakulam plant located in the special economic zone in Andhra Pradesh, the USFDA recorded no observations. However, the USFDA had recently issued Form 483 to Dr Reddy's Laboratories' another API facility plant at Srikakulam with two observations.
In the case of violation of the Food Drug and Cosmetic Act, the USFDA issues Form 483, post which the pharma company responds to the observations with corrective action plans and its immediate implementation.
At present, Dr Reddy's Laboratories has more than 190 medications and over 60 active pharmaceutical ingredients (APIs) for the manufacturing of drugs, diagnostic kits along with critical care and biotechnology products.
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