Ranbaxy again feels FDA heat – this time over US plant

Delhi-based drug manufacturer Ranbaxy Laboratories has received a warning from the Food and Drug Administration (FDA) over violation of good manufacturing practices (GMP) norms at one of its manufacturing facilities in the US, the company said in a statement on Thursday.

The FDA issued a warning letter to Ohm Laboratories Inc - a wholly-owned subsidiary of Ranbaxy - on 21 December saying that GMP norms had been violated at Ohm's liquid manufacturing facility in Gloversville, New York. The warning was based on on-site inspections conducted between July and August 2009.

''Ohm has retained the services of PRTM, a global consulting firm, to provide expertise and advice on issues cited by the FDA at its facility in the USA,'' the company's statement says. Ranbaxy itself is now owned by Japan's Daiichi Sankyo Co Ltd, since the tewo companies agred to a takeover in 2008 (See: Japan's Daiichi Sankyo to acquire majority stake in Ranbaxy).

The FDA had inspected two other plants of Ohm earlier this year and did not observe any material deviation. These plants manufacture most of the products supplied in the US market, the release says. Ohm sells generic and private branded labels and over-the-counter (OTC) drugs in the US.

This is the third FDA warning Ranbaxy has received in a span of 15 months. The earlier two notices in September 2008 concerned GMP violations at its factories in Dewas in Madhya Pradesh and Paonta Sahib in Himachal Pradesh. The two sites continue to be under FDA suspension, while 30 of Ranbaxy's drugs have been banned from the US market.

Just last month, Ranbaxy had launched a generic version of GlaxoSmithKline's herpes treatment drug Valtrex in the US, with a 180-day marketing exclusivity. The FDA has granted approval for the drug to be manufactured in the US by Ohm Laboratories. Some analysts find it curious that the FDA action comes just two days before GSK's Valtrex patent expires.