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Dr Reddy's receives FDA warning over three facilities

Fri, Nov 06, 2015, 04:28 PM
Hyderabad, Nov 6: Leading drugmaker Dr Reddy's Laboratories on Friday acknowledged having received a warning letter from the US FDA relating to its three manufacturing plants in Andhra Pradesh and Telangana.

Reddy's also said it would respond with a comprehensive plan to the US Food and Drug Administration (FDA).

The US regulator issued the warning over inadequate quality control at API (active pharmaceutical ingredient) manufacturing facilities at Srikakulam in Andhra Pradesh and Miryalaguda in Telangana, as well as oncology formulation manufacturing facility at Duvvada, Visakhapatnam, also in Andhra.

The action followed inspections of these sites by the agency in November 2014 and January and February this year, Dr Reddy's said in a statement.

The company said it takes quality and compliance matters seriously and stands by its commitment to fully comply with the CGMP (current good manufacturing practice) quality standards across all its facilities.

"We will respond with a comprehensive plan to address these observations within the stipulated time-frame of 15 days. We will continue to actively engage with the agency to resolve these issues," said G.V. Prasad, CEO at Dr Reddy's.

"We have also embarked on an initiative to revamp our quality systems and processes, as an organisation-wide priority," said Prasad.
Agency: IANS
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