The US Food and Drug Administration (FDA) has issued a warning to leading drug maker Dr. Reddy's Laboratories 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 Pradesh.
Dr. Reddy's Laboratories on Friday, November 7, 2015, has 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, "We will respond with a comprehensive plan to the US Food and Drug Administration (FDA)."
‘Leading drug maker Dr. Reddy's Laboratories has received a warning letter from the US FDA relating to its three manufacturing plants in Andhra Pradesh and Telangana. The action followed inspections of these sites by the US agency in November 2014 and January and February 2015.’
AdvertisementDr. Reddy's said, "The action followed inspections of these sites by the agency in November 2014 and January and February this year. 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."
G.V. Prasad, CEO at Dr Reddy's, said, "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. We have also embarked on an initiative to revamp our quality systems and processes, as an organization-wide priority."
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