Wockhardt gets another USFDA warning

Drugmaker Wockhardt’s US business has suffered another jolt with the US drug regulator issuing a warning letter to the company's Morton Grove manufacturing plant.

Three of its plants in India are already under an import alert and the US Food and Drug Administration (USFDA)’s latest action means that Wockhardt will not receive approvals for products filed from Morton Grove plant in the US.

Wockhardt said it was addressing issues raised by the regulator. In a notification to the exchange on Wednesday, it said the warning letter “would mean that the current portfolio of the company will continue to be made available in the market. However, new approvals will be withheld till resolution. The company, with the help of consultants, has already initiated appropriate measures since last several months to address the issues raised by the USFDA.”

Wockhardt’s plants in Chikalthana and Waluj in Aurangabad and active pharmaceutical ingredients manufacturing unit in Ankleshwar have import alerts against them. Currently, it is able to export only two products from Chikalthana to the US. Other than this, Wockhardt serves the US market from its manufacturing plant in Morton Grove near Chicago.

Non-compliance has resulted in 66 per cent fall in the US revenue over the past four years. In 2012-13, the US business accounted 52 per cent of its operating revenue and in FY16 it fell to 22 per cent.