Ranbaxy US units gets warning notice from FDA

Ranbaxy US units gets warning notice from FDA

Mumbai: Drugmaker Ranbaxy Laboratories Ltd said on Thursday its wholly-owned US-based unit Ohm Laboratories Inc has received a warning letter from the US Food and Drug Administration (FDA) relating to violations of good manufacturing practices.

The FDA letter, dated 21 December, mentions violations at Ohm’s liquid manufacturing facility in Gloversville, New York, Ranbaxy said in a statement on Thursday after markets closed for a four-day weekend.

The FDA conducted site inspections at the plant in July and August 2009.

“The company will continue to cooperate with the US FDA to bring the matter to closure in a timely manner and remains committed in its efforts to be fully compliant with US regulatory standards," Ranbaxy said.

Ohm has retained global consulting firm PRTM Inc to advise on issues cited by the FDA, it said.

Ohm Laboratories operates three US-based manufacturing facilities and sells generic and branded private label drugs in the United States.

Ranbaxy said the FDA inspected Ohm’s other two plants earlier this year but did not observe any material deviations.

Ranbaxy is majority owned by Japan’s Daiichi Sankyo.

Late last year, Ranbaxy shares plummeted after a US ban on some of its products. The FDA in February said Ranbaxy had sold misbranded or adulterated drugs in the United States, its largest market. Daiichi has since replaced Ranbaxy’s chief with one of its own executives.

Ahead of the announcement, Ranbaxy shares, valued at $4.75 billion, closed down 1.55% at Rs520.05, in a Mumbai market that rose 0.75%.