In November 2015, the company said it had received a warning letter from the US Food and Drug Administration (USFDA) for three of its sites -- active pharmaceutical ingredient (API) manufacturing facilities at Srikakulum, Andhra Pradesh, and Miryalguda, Telengana, and Oncology formulation manufacturing facility at Duvadda, Visakhapatnam, Andhra Pradesh.
Drug firm Dr Reddy's Laboratories on Friday said the US health regulator Food has “closed” warning letter issued for three of its sites in Andhra Pradesh and Telangana, following evaluation of corrective actions taken by the company.
In November 2015, the company said it had received a warning letter from the US Food and Drug Administration (USFDA) for three of its sites -- active pharmaceutical ingredient (API) manufacturing facilities at Srikakulum, Andhra Pradesh, and Miryalguda, Telengana, and Oncology formulation manufacturing facility at Duvadda, Visakhapatnam, Andhra Pradesh.
"...We have now been informed by the USFDA that based on its evaluation, we have addressed the violations and deviations contained in the said warning letter. With this, the said warning letter has been closed," Dr Reddy's Laboratories said in a regulatory filing.