Update on Dr Reddy's FDA warning letter
09 December 2015 | News | By BioSpectrum Bureau
Update on Dr Reddy's FDA warning letter
Dr Reddy's has received a warning letter issued by the US FDA on November 05
Dr Reddy's Laboratories (DRL) has submitted a response to the US Food and Drug Administration (US FDA) on December 7, 2015, the firm said in a filing to BSE.
Dr Reddy's has received a warning letter issued by the US FDA on November 05, 2015 relating to its API manufacturing facilities at Srikakulam, Andhra Pradesh and Miryalaguda, Telangana, as well as Oncology Formulation manufacturing facility at Duvvada, Visakhapatnam, Andhra Pradesh.
In response to the letter, Mr G V Prasad, CEO, DRL said, "We are in the process of shifting some of the products from these plants to other facilities and considering third party assessment for its plants."
