USFDA Bans Imports From 2 Plants Of Indian Drugmaker IPCA Laboratories

The U.S. Food and Drug Administration (USFDA) issued an import alert against two plants of Indian drugmaker IPCA Laboratories Ltd on Tuesday, stating that the generic medicines manufactured at the plants were not in conformity with its “current good manufacturing practices.” Earlier, in January, the agency had also banned imports from another IPCA plant in India.

The latest import alert bans shipments from IPCA’s manufacturing units in Pithampur in the Indian state of Madhya Pradesh and Silvassa in the union territory of Dadra and Nagar Haveli. The details about the exports that have been affected by the ban were not disclosed.

Reacting to the ban, the Mumbai-based company reportedly said it is “committed in resolving this issue at the earliest,” adding that it has not shipped any drugs to the U.S. since July 2014, except those that are exempt from the import alert.

Indian drugmakers account for nearly 40 percent of U.S. generic drug imports. However, in recent years, the USFDA has stepped up scrutiny of Indian pharmaceutical companies and issued several bans and warning letters. Last year, the agency had issued import alerts against four plants run by Ranbaxy Laboratories Limited.

Following the latest announcement, IPCA’s shares were down 12.5 percent on Wednesday at 665 rupees ($10.6) per share on the Bombay Stock Exchange.