Just as Indian pharma-watchers were beginning to hope for a clean slate at the FDA, the agency has cracked down on two drugmakers. A Dr. Reddy's plant in Mexico is now under an import ban until manufacturing issues there are resolved. And Cadila Healthcare got a new warning from the FDA based on an inspection at its new injectables facility in Gujarat, India.
The Dr. Reddy's trouble isn't completely unexpected. The company received an FDA warning letter last month about problems at the Mexican plant, which makes drug ingredients and intermediates. Operated by Dr. Reddy's unit Industrias Quimicas Falcon de Mexico, the plant was cited for several manufacturing shortfalls, and the agency warned that it might find its products barred from the U.S. And now it has.
The Cadila Healthcare move comes after a pre-approval FDA inspection at the Gujarat facility. Because the company hasn't yet been able to import products from that plant into the U.S., the warning won't immediately affect the company's numbers, Elara Securities analyst Surajit Pal told the Wall Street Journal. But if the issues aren't resolved soon, Cadila could see a delay in U.S. approvals for its injectables. "We are addressing the issue expeditiously to resolve the matter," a Cadila spokesman told the WSJ. "We do not expect any impact on our current business."
It's just the latest in a series of warnings and bans involving Indian drugmakers. The longest-running is Ranbaxy Laboratories' import ban, which has kept at least 30 products out of the U.S. since 2009. Aurobindo Pharma has also found itself in the FDA's spotlight of late.