The FDA has issued warning letters to two Cadila Healthcare facilities in India, including its formulation plant in Moraiya and its Zyfine API plant in Ahmedabad.
The company acknowledged the warning letters in a report to the Bombay Stock Exchange, though Cadila didn't disclose what issues the U.S. regulatory agency had with the facilities. A little over a year ago, the drugmaker said it received a Form 483 for its Moraiya plant following a "product-specific" inspection. The company said no products shipped to the U.S. were made with APIs from the Zyfine plant.
Cadila, along with other Indian drugmakers like Sun Pharmaceutical, Dr. Reddy's Laboratories ($RDY) and Mylan's ($MYL) sterile injectable operations, has been the focus of FDA efforts to improve the standards of the country's pharma industry.
"We are committed to resolve all the issues and revamp our quality systems and processes as the top most priority," the company said in the filing.
Financial analysts cited by The Telegraph said the Moraiya plant represents almost 60% of the company's U.S. revenue, which reached about $151 million in the second quarter. The FDA's action and any fix that might affect production has the potential to raise financial challenges for Cadila.
For several years, the agency has gone after Indian drugmakers in an effort to raise their pharma production standards, although some Indian industry and government leaders have said the FDA keeps changing its standards. They have also suggested India has been singled out by the agency. In response, the FDA points out that India accounts for about 40% of the generic and over-the-counter drugs sold in the U.S., which requires the agency to make sure those products meet U.S. standards.