The US regulator found fault with API (active pharmaceutical ingredient) production facilities at Srikakulam in the southeastern state of Andhra Pradesh and Miryalaguda in the southern state of Telangana, as well as oncology formulation at Duvvada near Visakhapatnam, Andhra Pradesh.
The Warning Letter arrived after FDA inspections in November 2014, January 2015 and February 2015 respectively.
Dr Reddy’s CEO GV Prasad commented “We take quality and compliance matters seriously and standby 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 we have also embarked on an initiative to revamp our quality systems and processes, as an organization-wide priority.”
This time last year, the Skrikakulam API site was hit by an FDA Form 483 with nine observations about the plant’s procedures, although a spokesperson at the time told in-Pharmatechnologist.com “there is no implication on manufacturing and […] production continues as normal.”
The Skrikakulam facility makes APIs for foreign export, including bromfenacna, celecoxib, ibuprofen, ketorolac tromethamine, naproxen, naproxen sodium, glimeprid, linagliptin, liraglutide, and nateglinide.
Dr Reddy’s shares on the BSE (Bombay Stock Exchange) slumped 14% on Friday since the company’s announcement and closed at 3,630 rupees ($55). The firm reported global revenue of 148.2bn rupees ($2.23m) in the last financial year.