Mumbai
Cadila Healthcare Ltd has received a U.S. Food and Drug Administration (FDA) warning letter for violating manufacturing standards at two of its production facilities, the latest in a series of Indian companies to face such action.
Cadila shares plunged as much as 17 percent to their lowest intraday level since March in Mumbai on Thursday and closed down about 15 percent.
The warning letter cites issues with Cadila's plants in Gujarat, including at the Moraiya facility, which makes up about 60 percent of the company's total sales in the United States, its largest market.
Dozens of Indian drug plants have faced warnings and bans in recent years, as the FDA improved inspections of foreign facilities. More than 40 percent of the generic and over the counter medicines available in the United States comes from Indian facilities such as Cadila's Moraiya plant.
Cadila Managing Director Pankaj Patel told analysts on a conference call the FDA, during an inspection of the Moraiya plant in September 2014, found deficiencies with the way the company investigated market complaints about a medicine made there.
A batch of that medicine repeatedly failed a manufacturing-related test, after which the company stopped producing it, Patel said on Thursday, without naming the product.
At the other plant cited in the letter, where Cadila makes raw materials for finished drugs, Patel said the company had already identified problems and was working on fixing them before the FDA came to inspect.
