The US drug regulator is set to begin an inspection of Dr. Reddy's Srikakulam unit in Andhra Pradesh on March 27, sources have told CNBC-TV18.
The plant is very critical in terms of supplying active pharmaceutical ingredients (APIs).
In November 2015, the US Food and Drug Administration sent a warning letter to Dr Reddy's for alleged violations in manufacturing standards at its active pharmaceutical ingredient plants at Srikakulam in Andhra Pradesh and Miryalaguda in Telangana, and an oncology formulations facility in Visakhapatnam (Andhra Pradesh).
The three facilities contribute about 10-12 percent of company sales.
Dr. Reddy’s said it collectively spent about $35-40 million on remediation work that includes legal and professional charges.
The drugmaker was in focus earlier this week after it received repeat observations from the US Food and Drug Administration on its Duvvada oncology formulation facility in Visakhapatnam.
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