Dr Reddy's says US FDA has issued Form 483 for Srikakulam API plant
The US Food and Drug Adminisatration (FDA) has completed its inspection of Dr Reddy’s API plant in Srikakulam, Andhra Pradesh and issued the firm with a Form483 detailing two observations.
Dr Reddy’s confirmed the inspection in a Bombay Stock Exchange (BSE) filing today, explaining that it is already addressing the observations.
The Srikakulam facility was one of three Dr Reddy’s sites issued with a US FDA warning letter in 2015, the others being its finished formulation plant in Duvvada - also in Andhra Pradesh – and its API factory in Tripuraram, Telangana.
The plant makes APIs for foreign export, including bromfenacna, celecoxib, ibuprofen, ketorolac tromethamine, naproxen, naproxen sodium, glimeprid, linagliptin, liraglutide, and nateglinide.
