Dr Reddy's says US FDA has issued Form 483 for Srikakulam API plant

By Gareth Macdonald

- Last updated on GMT

iStock/Vepar5
iStock/Vepar5

Related tags Andhra pradesh Dr reddy Food and drug administration

The US FDA has completed its inspection of Dr Reddy’s API plant in Srikakulam, Andhra Pradesh and issued the firm with a Form 483 detailing two observations.

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.

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