Hyderabad: Dr Reddy’s Laboratories, India’s second largest drug firm by sales, on Friday said that a German regulatory authority has issued six major observations against its formulations unit at Visakhapatnam in Andhra Pradesh after an inspection.
“The Regulatory Authority of Germany (Regierung von Oberbayern) concluded an audit of our formulations facility in Duvvada, Visakhapatnam with zero critical and six major observations,” DRL said in a BSE filing.
The company, however, did not disclose the observations made by the regulator.
“The company will be submitting a corrective and preventive action plan to the authorities. The auditor has cautioned that the facility will receive EU-GMP ce-rtification from the regulator up to November 2018 only when the regulator approves the CAPA,” Dr Reddy's said.
The company had earlier received 13 observations from the US health regulator, USFDA, for its formulations manufacturing facility at Visakhapatnam in March....