Dr. Reddy's Laboratories (DRL) today issued a statement acknowledging receipt of a warning letter from the US FDA on November 5, 2015, relating to its API manufacturing facilities at Srikakulam in Andhra Pradesh and Miryalaguda in Telangana, and its oncology formulation manufacturing facility at Duvvada, Visakhapatnam, AP.
The action followed the inspections of these sites by the agency in November of last year and January and February of this year.
Dr Reddy's CEO G V Prasad stated, "We take quality and compliance matters seriously and stand by our commitment to fully comply with the cGMP quality standards across all of our 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, and have also embarked on an initiative to revamp our quality systems and processes, as an organization-wide priority."
The stock price of DRL crashed a whopping 14.65% in response to the news.