The FDA has issued generics giant Ranbaxy Laboratories with two warning letters, detailing “extensive deviations from US cGMP requirements” at the firm’s manufacturing plants in Dewas and Paonta Sahib, India.
In addition, the US Food and Drug Administration (FDA) has blocked the import of active pharmaceutical ingredients (APIs), including clarithromycin valacyclovir HCl, pravastatin sodium and acyclovir, as well as 30 finished drug products made at the two facilities. The complete list can be found here .
The FDA said that it had not blocked importation of the generic antiviral ganciclovir, which is also made at the facilities, on the basis that Ranbaxy is the sole supplier to the US market. The agency reiterated that all other Ranbaxy products covered by its action could be replaced by other manufacturers.
The FDA also said that it “has no evidence of harm to any patients who have taken drugs made at the two facilities,” explaining that its move was a preventative measure purely based on certain current good manufacturing practice (cGMP) shortcomings it has observed.
Janet Woodcock, director of the FDA's Centre for Drug Evaluation and Research, spoke in stronger terms, commenting that: "With this action we are sending a clear signal that drug products intended for use by American consumers must meet our standards of safety and quality."
In response, Ranbaxy said that it is “very disappointed in the action FDA has taken.... The company has responded to each concern FDA has raised during the past two years and had thought that progress was being made.
“The company has just received the warning letters that FDA has issued and has not had the opportunity to review those concerns that FDA has determined are unresolved. Once it has had an opportunity to review the issues, the company looks forward to continuing to cooperate with FDA to resolve the remaining issues,” continued the statement.
Ranbaxy also stressed that the FDA had not questioned the “safety or effectiveness” of any of its drugs and added that the warning letters do not apply to any of its US manufacturing facilities that are run by its Ohm Laboratories subsidiary.
Long running saga
For the past three years Ranbaxy, which is due to be bought by Japan’s Daiichi Sankyo, has been the subject of a variety of FDA actions, including a raid at the company's US headquarters and New Brunswick manufacturing facility.
In June, Ranbaxy's share price tumbled followed the US Department of Justice filing documents with a district court in Maryland covering whether Ranbaxy had falsified clinical data to achieve compliance with US regulations.
Speaking shortly after the filing, company CEO Malvinder Singh, asserted that this action would be dropped and reiterated his belief that the accusations were being orchestrated by a big pharma company acting in cahoots with “negative elements” in India.