German regulator clears Wockhardt's Ankleshwar plant

Moneycontrol BureauTwo days after receiving a warning letter from USFDA for its active pharmaceutical ingredient (APIs) plant in Ankleshwar, Gujarat, drug maker Wockhardt on Thursday said the company cleared an inspection of German drug regulator for the same plant.The German clearance allows the company to continue its supply of APIs across European Union."We wish to inform you that competent authority, Berlin, Germany has since issued EU GMP certificate confirming that our manufacturing facility at 138, GIDC Estate, Ankleshwar, Gujarat complies with the principles of good manufacturing practices,” Wockhardt said in a statement. The certificate issued in this regard is valid for 3 years, the company said. The company said there were no specific observations from German regulator.The Ankleshwar plant largely caters to domestic and European markets, with some exports of active pharmaceutical ingredients to Wockhardt’s US plant.European Union contributed about 37 percent of Wockhardt’s revenue of Rs.4,461.4 crore in the year ended March, followed by India at 32 percent. APIs produced in Ankleshwar plant are used in formulations exported to the European market.Ankleshwar plant was banned in August last year by US Food and Drug Administration (USFDA) from supplying drugs to that country on issues such as data integrity concerns and microbial contamination of sterile unit, among others.The import alert and subsequent warning letter to Ankleshwar plant by USFDA had no impact on supplies to Europe and rest of the world, said Habil Khorakiwala in an interview to CNBC-TV18. So far 4-5 facilities have clearances to supply formulations and APIs to Europe, Khorakiwala said.Shares of Wockhardt rose 1.25 percent to close at Rs 673.30 on BSE on Thursday.