Another USFDA warning for Wockhardt; US plant faces product approval freeze

Three Indian plants already under alert; Non-compliance shaves off 66% in US revenue in last 4 years

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 in that country.

Three of its plants in India are already under an import alert and FDA's latest action means that Wockhardt will not receive approvals for products filed from the 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 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 the consultants, has already initiated appropriate measures since last several months to address the issues raised by USFDA."

Wockhardt's plants in Chikhalthana and Waluj in Aurangabad and active pharmaceutical ingredients manufacturing unit in Ankleshwar have import alerts against them. At present, the company is able to export only two products from Chikhalthana 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 US revenue over the last four years. In 2012-13 US business accounted 52 per cent of its operating revenue and in FY 16 it fell to 22 per cent.