Another of India's large generic drugmakers has found itself in serious problems with the FDA. Just a week after Ranbaxy Laboratories essentially closed out its long-running problems with authorities with a $500 million settlement, Wockhardt says the FDA has issued an import alert that could cost it $100 million in lost sales.
The alert was issued Wednesday after a routine inspection found manufacturing issues with a Wockhardt plant in Aurangabad in Maharashtra, Reuters reports. In April, the company issued a statement on its website that the FDA had issued a Form 483 for problems it observed at the solid dose and sterile injectables plant. Wockhardt said it had initiated an accelerated and comprehensive remedial measure and was committed to achieving full compliance in the shortest period of time.
Wockhardt Chairman Habil Khorakiwala told the Indian press service PTI that the ban could cost the company $100 million in lost sales but that Wockhardt would shift production to some other plants to limit the financial damage, the Business Standard reported.
An import ban is a costly measure. Ranbaxy, which last week agreed to pay $500 million to settle one of the largest pharmaceutical enforcement actions tied to drug-manufacturing issues, still has two plants in India that it cannot use to produce drugs for the U.S. market. That means it must rely on more expensive manufacturing elsewhere. It said this week that it has spent $300 million upgrading the facilities and meeting FDA expectations. Canada's generic drugmaker Apotex is seeking damages before international mediators, claiming that a two-year import ban the FDA issued against it "decimated" its business. Its claim says the ban cost it more than $520 million. It has argued that the ban, which was lifted in 2011, violated the North American Free Trade Agreement.
- here's the Reuters story
- read the Business Standard story
- here's Wockhardt's April statement