US FDA slaps warning letter on Ranbaxy’s liquids manufacturing unit Ohm Labs

US FDA has again slapped a warning letter on a Ranbaxy unit Ohm Laboratories Inc for alleged violations in manufacturing practices denting considerably the sales prospects of the Daiichi-owned company in US.

Ohm Laboratories, one of Ranbaxy’s three manufacturing facilities located in US, has received a warning letter dated 21 December from US Food and Drug Administration.

Ohm Laboratory is a liquid manufacturing facility based in Gloversville, New York.

US FDA followed an inspection at the plant between July and August.

Earlier in September, US FDA issued warning letters to Ranbaxy’s factories in Paonta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh and had blocked the import of 30 generic drugs from these two facilities to the United States.

US FDA conducted an inspection in Ranbaxy’s Paonta Sahib facility in Himachal Pradesh during 2008. Following these findings, the regulator has decided to revoke licences of 25 products made in this factory, FDA also stopped a number of apllication from this facility pending approval.

The US drug regulator which hauled up India’s leading generic maker for repeatedly violating manufacturing norms since atleast 2006, found out 1,676 errors in the audit of 15 applications approved for the US market.

Ranbaxy Laboratories Ltd,in which Japan’s Daiichi Sankyo owns about 64 percent, reported net loss of 7.78 billion rupees ($156 million) in its fiscal first quarter ended March 2009, compared with a profit of 1.03 billion rupees in the year-ago quarter, following the US FDA action.

Ranbaxy Laboratories Ltd also said it anticipates a loss of $150 million on sales of $1.4 billion in the year ending December 2009.

Ranbaxy’s sales in the US, the world’s largest drug market, also dropped 14 percent.

Ranbaxy’s sales in North America, which accounts for about 27 percent of Ranbaxy’s revenue, fell 7 percent to 4.04 billion rupees in the fourth quarter of financial year 2008-2009. Sales in the U.S. declined to 3.4 billion rupees. Ranbaxy also said sales dropped 14 percent in Europe, and gained 9 percent in India.

Ranbaxy reported 9.19 billion rupees as losses on foreign-currency options before tax. The company also wrote down the value of convertible bonds due 2011 as the Indian currency weakened 3.9 percent against the dollar in the three- month period, its fifth straight quarterly decline.