Dr Reddy's gets extra time to respond to warning letter
27 November 2015 | News | By BioSpectrum Bureau
Dr Reddy's gets extra time to respond to warning letter
The firm is in the process of preparing a response to the letter
Dr Reddy's Laboratories (DRL) has said that the US Food and Drug Administration (US FDA) has extended the time-frame for replying to the warning letter issued to the company by about two weeks to 7 December.
On November 5, 2015, the company has received a warning letter issued by the US health regulator 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.
Dr Reddy's is in the process of preparing a response to FDA's warning letter. The FDA has granted an extension until December 7, 2015 for the submission of the Company's response to its warning letter.
