Dr Reddy’s says U.S. FDA raises fresh concerns at Srikakulam drug plant


MUMBAI: India’s Dr Reddy’s Laboratories Ltd said on Tuesday that the U.S. Food and Drug Administration has outlined two more concerns with the company’s Srikakulam drug-making plant after an inspection of the facility.

Dr Reddy’s, which derives a majority of its sales from the United States, said in statement that it had received an inspection letter known as ‘form 483’ from the FDA about the Srikakulam plant and was addressing the concerns.

It did not say what the FDA observations were, and the FDA typically does not make such letters public. The Srikakulam plant was one of Dr Reddy’s main facilities for producing active pharmaceutical ingredients (APIs) but production was hit after the FDA issued a warning over inadequate quality control practices there in 2015.(http://reut.rs/2o5AOfa)

India’s second-biggest drugmaker by sales has said it has since been working on improving its processes at the plant, but in the meantime some of its other important facilities have also faced FDA restrictions over similar problems.



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