Wockhardt to toe US FDA line on Shendra unit

Says compliance will be done in 2 months; stock falls 4% as plans to revive US business suffer

Drug maker Wockhardt expects to comply with all the US Food and Drug Administration’s (FDA’s) observations on its Shendra unit in two months, the company’s chairman, Habil Khorakiwala, said on Monday.

The FDA has already barred import from Wockhardt’s Waluj and Chikhalthana units (these two and Shendra are all within 20 km of Aurangabad) and the company plans to use the Shendra plant to export products to the US. It had sought approval for 15 products which it proposes to manufacture from Shendra for that market.

“The FDA  has made nine observations about the Shendra plant but we believe none of them are critical. By the time we respond to the FDA in 15 days, we would have complied with half of these and we expect to comply with the balance in two months,” Khorakiwala stated in a conference call with journalists. He added there were no data integrity issues at this plant but would not give details on the US regulator's observations.  

Sales to the US market  declined 50 per cent in FY15 after the FDA’s import alerts. The company's stock fell nearly 15 per cent on Friday, following reports of the FDA’s adverse observations on Shendra. On Monday morning, the stock was down four per cent in intra-day trade.

At present, Wockhardt supplies drugs to the US market through its plant in Chicago and third-party manufacturing sites. In all, it has filed 15 products from third-party sites for FDA approval.

Khorakiwala said the company was in dialogue with the FDA regarding the Chikhalthana and Waluj units, and had made significant progress on the regulator's observations. He expects resolution of the issues at these plants in the coming months. He added sales in Britain, India and emerging markets were growing at 20 per cent yearly and expects this level of rise to continue.