Losses estimated at $100 million

The US Food and Drug Administration has issued an import alert on Wockhardt’s manufacturing plant at Waluj, Aurangabad. In a conference called, Habil Khorakiwala, Chairman, Wockhardt, clarified the losses in revenue from the import alert could be up to $100 million in annualised revenue and the company should be able to restore most of that within six to nine months, by shifting production to other plants. However, apart from the $100-million loss, Wockhardt’s new generic drug launches in the US are likely to be hit. Of the 45-46 abbreviated new drug applications, pending at the FDA, half of these were filed from the Waluj facility. “We have 45-47 pending ANDAs. Obviously, half of them have been filed from this facility, and the other half were filed from other facilities, so that is not affected at all,” said Khorakiwala. He made it clear that no drugs would be recalled from the US, after the FDA import alert. According to him, the production of 25% of injectables and rest of solid formulations would be shifted to plants in Shendra and another in Aurangabad. The process could take six-nine months, but whether the company would have a smooth transition is unclear. The company is expecting a two per cent fall in margin in FY14, due to the suspension of manufacturing at the Waluj plant. Company’s major products, such as Toprol and Flonase, are not manufactured at Waluj. The collective value of business in injectable, about $25 million and about $75 million or so is in solid dosage form.