A Jubilant Life Sciences plant has joined a growing list of Indian drugmakers' facilities that have gotten crosswise with the FDA lately. But this time it is for a plant in the U.S., the second Jubilant plant in North America tagged by the agency this year.
The drugmaker reported today that the FDA sent it a warning letter for problems at its Jubilant HollisterStier plant in Spokane, WA. According to Reuters, sales of drugs from the facility accounted for 7% of the drugmaker's revenues in the 6 months ended in September. The company told the news service in a statement that the warning could prevent the facility from applying for new drug approvals but that it didn't expect it to interrupt production of products currently coming out of that facility.
Indian companies produce about 40% of the generic drugs sold in the U.S., but some of the biggest have found themselves facing significant issues with the FDA. Just this week, the regulator posted a warning letter sent to India's Wockhardt, a company that now has two of its Indian plants banned from shipping products to the U.S. In September, the FDA took the same action against a Ranbaxy Laboratories plant in India, the third of its facilities there to be prevented from shipping to the U.S. All of the companies claim they are addressing FDA concerns. The agency is giving special attention to drugmakers in India, having beefed up its inspection staff there and named an Indian-born Ph.D. to oversee the operation.
It is not as if Jubilant has not been schooled in what the FDA expects. In February, the agency issued a warning letter to its Kirkland, Québec, facility where it manufactures sterile injectable products. That letter was tied to inspections done a year earlier. The inspectors said the facility had released lots from its plant even though some of the batches were out of spec.
- read the Reuters story