The warning comes at a time when exports from two of the company’s manufacturing sites in India continue to be suspended by the US regulator.
Ranbaxy Laboratories’ has received a warning from the US drug regulator Food and Drug Administration (FDA) over one of its manufacturing facilities in the US, the company has said in a statement.
The warning comes at a time when exports from two of the company’s manufacturing sites in India continue to be suspended by the US regulator due to manufacturing defects.
The FDA issued a warning letter to Ohm Laboratories — a wholly-owned subsidiary of Ranbaxy — on December 21, pointing out that certain good manufacturing practices had been violated at the liquid manufacturing facility located in Gloversville, New York. The FDA warning was based 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.
Analysts say the development may not have any material impact on Ranbaxy as it is only a warning and the facility makes only one drug — the anti-allergic cetrizine — which gives the Daiichi Sankyo-owned company revenues of less than Rs 50 crore per annum in the US. However, the US is Ranbaxy’s largest export market.
Ohm Laboratories, which Ranbaxy acquired in 1995, has three manufacturing facilities in the US. The unit under the regulator’s scanner produces only liquids.
“The development will not impact Ranbaxy, as the facility produces only one drug and none of its major products lined up for launch are liquids. But, its stocks may further fall on sentiments,” HDFC Securities Vice-President Ranjit Kapadia says. Ranbaxy’s stock fell 1.55 per cent to end at Rs 520.05 at the close of Thursday’s trade on the Bombay Stock Exchange.
Ranbaxy maintains it will continue to co-operate with the FDA to bring the matter to closure in a timely manner “and remains committed in its efforts of being fully compliant with the US regulatory standards, while offering affordable generic medicines to the US healthcare system.”
The FDA has banned Ranbaxy since September 2008 from selling about 30 drugs in the US market, following manufacturing defects detected at its Paonta Sahib and Dewas manufacturing facilities in India. The FDA had re-inspected one of the facilities recently and Ranbaxy is eagerly waiting for the outcome.
Earlier this year, the FDA had inspected two other plants of Ohm and did not observe any material deviation. These plants manufacture most of the products supplied in the US market, the release says.
Drug companies have to follow stringent current Good Manufacturing Practices (cGMP) standards for selling drugs in the US and any violation attracts a warning, which may lead to a ban on production if the company fails to rectify the defects.
Sun Pharma’s US subsidiary, Caraco, is also going through similar troubles with the US drug regulator, which had asked Caraco to stop production at three of its manufacturing units in June, following inspections.
