FDA bans fourth Ranbaxy factory halts exports to US

Development clearly unacceptable: CEO

In yet another setback for Ranbaxy, the US health regulator banned the import of products from its fourth plant, halting the shipment of all the company’s drugs to the US from India.

Citing manufacturing norm violations, the US Food and Drug Administration (USFDA) prohibited Ranbaxy Laboratories from distributing drugs produced at the Toansa unit in Punjab, including medicines made by the company’s Ohm Laboratories facility in New Jersey.

In an order on Thursday, the USFDA also prohibited Ranbaxy from providing active pharmaceutical ingredients from Toansa to other companies, including other Ranbaxy facilities, that make products for American consumers.

“We are taking swift action to prevent substandard quality products from reaching US consumers,” said Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.

The USFDA said it exercised its authority under a provision in a January 2012 consent decree, which permits the agency to extend those terms to any Ranbaxy-owned or operated facility if an FDA inspection finds it in violation of the Federal Food, Drug, and Cosmetic Act or FDA regulations, including current good manufacturing practice requirements.

“This development is clearly unacceptable and an appropriate management action will be taken upon completion of the internal investigation,” Ranbaxy Chief Executive Officer and Managing Director Arun Sawhney said.

Expressing disappointment, the company said it “would like to apologise to all its stakeholders for the inconvenience caused by the suspension.”

Japanese parent Daiichi Sankyo confirmed the Toansa plant is now subject to certain terms of the consent decree of permanent injunction entered against Ranbaxy in January 2012.

Ranbaxy will cooperate with the USFDA and comply with the consent decree in both letter and spirit, it said.