US import alert could impact biz by $100 m, says Wockhardt

Drug firm Wockhardt today said import alert issued by the US health regulator on its manufacturing facility near Aurangabad could impact the company’s business by $100 million.

“The USFDA has put an import alert on one of our facilities at Waluj, near Aurangabad. We estimate that it would impact our business by $100 million on an annualised basis,” Wockhardt Chairman Habil Khorakiwala said.

He added that till the time USFDA lifts the import alert, the company would not be able to export products to the US market from the facility, which produces injectables as well as solid dosages.

Shares of the Mumbai based Wockhardt today tanked by 20 per cent to close at Rs 1,315.25.

Khorakiwala said the company is shifting the manufacturing of injectable products to another facility in the vicinity, there by minimising the impact.

“We plan to move 80 per cent of production of the injectables from Waluj plant to a nearby facility,” Khorakiwala said.

The US health regulator had issued an ‘import alert’ on drug firm Wockhardt’s facility at Aurangabad in Maharashtra saying that it was not meeting the manufacturing norms.

The import alert, ‘detention without physical examination of drugs from firms which have not met drug GMPs’, is issued when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practises (GMP’s), the United States Food and Drug Administration said on its website.

“DWPE of such firms remains in effect until such time as FDA is satisfied that the appearance of a violation has been removed, either by re-inspection or submission of appropriate documentation to the responsible FDA Centre,” it added.

An import alert allows FDA to detain, without physically examining, products that either have or potentially could violate the Food, Drug, and Cosmetic Act.