Global Processing

FDA bans import of drugs from Sun Pharma's Gujarat facility

March 24, 2014

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The U.S. Food and Drug Administration (FDA) has issued an import alert for Indian drug maker Sun Pharmaceuticals Ltd., banning the import of drug products manufactured at the company's Karkhadi facility in the state of Gujarat.

Sun Pharmaceuticals, which is the country's largest producer of drugs by market value, stated that revenues from the affected facility were minimal and the ban would not have a significant impact on the company's operations. Sun Pharma's Karkhadi unit manufactures active pharmaceutical ingredients and formulations, according to the corporate website.

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According to Sun Pharma, the ban was imposed as a follow-up to a facility inspection carried out by FDA officials who detected numerous cases of non-compliance with good manufacturing practices adopted by the industry. The drug maker announced that it was committed to correcting the problems detected at the facility and was already implementing measures to ensure compliance with industry standards.

The ban imposed on Sun Pharma is the latest enforcement action taken by the U.S. drug regulator against Indian pharmaceutical companies. India is the largest supplier of generic drug products to the United States and the FDA has tightened its grip on substandard products. The most severe penalty to date was imposed on drug company Ranbaxy Laboratories, which had all of its production banned, regardless of the facility it came from. Other key market players that have been hit by the FDA to various extents include RPG Life Sciences, Wockhardt and Strides Arcolab.