Just two days after receiving the warning letter from USFDA for its active pharmaceutical ingredients (APIs) plant in Gujarat’s Ankleshwar, the drug maker Wockhardt said that the company has cleared an inspection of German drug regulator for the same plant.
Now the German clearance allows the company to continue its supply of APIs across the European Union.
The Ankleshwar plant largely caters to domestic and European markets, with some exports of active pharmaceutical ingredients to Wockhardt’s US plant.
The European Union contributed about 37 per cent of Wockhardt’s revenue of Rs 4,461 crore in the year ended March, followed by India with 32 per cent. APIs produced in Ankleshwar plant are used in formulations exported to the European market.
Ankleshwar plant was banned by the US Food and Drug Administration (USFDA) in August last year from supplying drugs to that country’s on issues such as data integrity concerns and microbial contamination of sterile unite, 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-TV 18.
The certificate issued is valid for three years.
