US FDA asks Ranbaxy to ensure plant standards compliance: report

The US Food and Drug Administration (US FDA) has asked Ranbaxy Laboratories to ensure that its plants making drugs for the US market meet the required standards, newspaper reports said today.

The US FDA had, in December, issued a warning to Ranbaxy's US facility, Ohm Laboratories, which sells generic and branded private label drugs.

The US regulator had, last year, banned some of the products of the generic drug maker. It had also hauled up the company for selling misbranded or adulterated drugs in the US.

Things, however, seemed to have improved for Ranbaxy after acquisition by Daiichi Sankyo. In June 2008, Ranbaxy entered into an alliance with one of the largest Japanese innovator companies, Daiichi Sankyo Company Ltd., to create an innovator and generic pharmaceutical powerhouse. The combined entity now ranks among the top 20 pharmaceutical companies, globally.

FDA, meanwhile, had conducted site inspections at Ohm Laboratories, Ranbaxy's manufacturing facilities in the US. In July and August last year, FDA inspected Ohm's liquid manufacturing facility in Gloversville, New York. And, on 21 December, the regulator sent a letter to the company pointing out violations of good manufacturing practices.

Ranbaxy said it had replied to the FDA letter.