Cadila Healthcare Ltd has joined a growing list of Indian drug makers being cited by the FDA over questionable manufacturing practices, quality, and non-compliance matters.
The latest warning letter cites issues at two of Cadila’s manufacturing plants in Gujarat, including the Moraiya formulation facility, which accounts for about 40 percent of the company’s total sales in its largest market, the United States, and the Ahmedabad API facility, according to Reuters.
The Moraiya facility was inspected over a year ago by the FDA, and a series of issues involving manufacturing practices were questioned at that time. Cadila chose to keep the results of the inspection from the public. However, in October of this year, Cadila said its remedial work at the facility was complete and the company was awaiting a formal response from the FDA.
Siddhant Khandekar, an analyst who tracks the company at ICICI Direct Ltd., says the FDA is apparently not satisfied with the remedial work taken by Cadila, and this is the reason for the warning letter. In any case, the FDA response caused Cadila shares plunged as much as 17 percent in intraday trading on Thursday in Mumbai.
In a conference call Thursday, Cadila Managing Director Pankaj Patel told analysts that during the FDA inspection in 2014, the agency found deficiencies with the way the company investigated market complaints about a medicine made there. Patel said a batch of medicine, which was not named, repeatedly failed a manufacturing-related test, so the company stopped producing the product.
As for the Ahmedabad API facility, where Cadila makes raw materials for finished drugs, Patel said the problems identified by the company were being worked on. “We took action including against management at the plant and then we started remediation action, and suspended all activity there,” Patel said. “While the remediation was going on, the FDA inspection occurred, and obviously, those things which were there were found.”
It has been over a year since Cadila has received approval from the FDA for any of its medications made at the Moraiya facility. Sun Pharmaceutical Industries Ltd, India’s largest drug maker, received a similar warning letter earlier in December over issues at its facility at Halol in Gujarat.
In November, Digital Journal reported that the second-largest pharmaceutical manufacturer in India, Dr. Reddy’s Laboratories, had received a warning letter from the FDA. Dr. Reddy’s Laboratories is based in Hyderabad, Telangana, India. The company produces some 190 drug products for India and overseas markets, including the U.S. and Europe.
In October this year, the FDA sent a warning letter to Novartis AG, after the drug maker was found in violation of manufacturing practices in 2014 at two of its India drug-making plants.
