India's largest drugmaker and huge supplier to the U.S. market, Sun Pharmaceutical Industries Limited, received a warning letter from U.S. Food and Drug Administration officials for violating manufacturing standards at its Halol plant in western India. Sun Pharma is estimated to supply 40 percent of the medicines sold in the United States. FDA inspectors first identified issues at the plant during September 2014, according the company's statement Saturday.
Sun Pharma is a multinational company headquartered in Mumbai, Maharashtra, which manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) in various therapeutic areas, such as cardiology, psychiatry, neurology, gastroenterology and diabetology. It also provides APIs such as warfarin, carbamazepine, etodolac, and clorazepate, as well as anticancers, steroids, peptides, sex hormones, and controlled substances, according to online sources.
The company has not received approvals for future drugs it manufactured at the Halol plant since September 2014.
The warning to Sun Pharma is the latest in a series of FDA actions over the past year against drug manufacturing plants in India, reports Hindustan Times.
FDA officials are not satisfied with the remedial measures Sun Pharma has taken at the plant since the fall when problems surfaced. In the company statement, Sun Pharma indicated "significant investments" in automation and training to improve quality systems at the plant had been made in response to FDA inspection. Company representatives also said external consultants were hired, and that they have been updating the agency on the corrective measures they were taking.
However, such a warning letter suggests the company is still months away from getting its plant cleared by the FDA, and the regulatory administrators could ban all drug imports from the plant if Sun Pharma fails to fix issues there, states Hindustan Times.
"Sun Pharma has always ensured that its products are safe and effective and there is no doubt on the safety of our products in the market," managing director Dilip Shanghvi said in a statement issued on Saturday.
He said company teams were taking steps to address the problems outlined by the FDA and that it would request a re-inspection of the Halol facility once it had completed the remedial steps.
Shanghvi also stated the company "continues to supply important drug products to meet obligations to customers and the patients who use its drugs in the United States and around the world."