|Wockhardt Managing Director Murtaza Khorakiwala|
Indian generic manufacturer Wockhardt has begun to feel the sting of an FDA ban on drugs made at two of its plants, with fourth quarter profits falling 78%. And worse may still be to come, with the FDA issuing a Form 483 to the facility in Illinois that is the engineroom of Wockhardt's U.S. business.
Livemint reports Wockhardt's fourth quarter U.S. sales are estimated to have fallen more than 50% year-on-year, with the FDA import alert against two Indian facilities accounting for the decline. As the import alerts mounted up last year, the one bright spot for Wockhardt was the continued quality compliance of the Illinois-based unit that generates more than half of U.S. sales. Now this too is under threat.
The Form 483 could be resolved without significantly affecting Wockhardt's business, but fears of another import alert loom. Wockhardt has taken steps to stop the situation from escalating by responding to FDA's observations, but the final outcome is unpredictable. "It's difficult to say what kind of position the FDA will take but according to us the inspection was not a very negative inspection," Wockhardt's Managing Director Murtaza Khorakiwala told analysts at a briefing attended by Reuters.
Khorakiwala was equally unsure about how FDA will respond to its attempts to fix the two plants in India that have been under import alerts since last year. While Khorakiwala thinks the facilities have made "significant progress," the only available independent assessment comes from the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA). Khorakiwala said the MHRA saw signs of improvement at the Chikalthana site, but is yet to lift the restrictions it imposed in 2013.