Dr Reddy’s, the Rs 1,800-crore pharmaceutical major, has achieved yet another major feat in its operations, with the United States Food & Drug Administration (US FDA) successfully completing inspection of two of its bulk actives facilities. While one facility was for Omeprazole and Tizanidine HCI, the other facility was for Keterolac Tromethamine. Dr Reddy’s has a total of six bulk actives manufacturing facilities and all of them had been US FDA-inspected.
Dr Reddy’s, in its News & Events Update, said the company had received ‘acceptable letters’ from the USFDA for two of its bulk actives facilities based at Hyderabad. The US FDA had inspected the two facilities from March 2 to 3, this year. The inspection covered a total of three bulk active products – Omeprazole, Tizanidine and Keterolac Tromethamine.
Dr Reddy’s is the only Indian pharmaceutical company listed on the New York Stock Exchange. The company had filed several ANDAs with the US FDA and the successful inspection of its manufacturing facilities by this Agency would give it a clear edge in the regulated markets.