Dr Reddy's Laboratories (DRL) today said the German drug regulator has concluded the audit of its Visakhapatnam formulations facility with six major observations.
Drug firm Dr Reddy’s Laboratories today said a German regulatory authority has issued six major observations against its formulations unit at Visakhapatnam in Andhra Pradesh after an inspection. The company, however, did not elaborate on the observations which were made by the regulator related to violations of good manufacturing practises (GMP). “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,” Dr Reddy’s Laboratories said in a BSE filing.
The products manufactured at the facility are currently not exported to the European Union, it added. “The company will be submitting a corrective and preventive action plan (CAPA) to the authorities. The auditor has cautioned that the facility will receive EU-GMP certification from the regulator up to November 2018 only when the regulator approves the CAPA,” Dr Reddy’s said. The facility’s compliance with the CAPA and other applicable regulations will be reviewed again by the regulator by November 2018 for continuation of EU-GMP certification, it added.
The company had earlier received 13 observations from the US health regulator, USFDA, for its formulations manufacturing facility at Duvvada, Visakhapatnam in March this year. The USFDA issues Form 483 observations after an inspection in which its investigator observe any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. It notifies the company’s management of the objectionable conditions. Shares of Dr Reddy’s Laboratories were trading at Rs 2,158.80 per scrip in the afternoon trade on BSE, down 2.93 per cent from its previous close.