Ranbaxy plant in India falsified data: US FDA
25 Feb 2009
The US Food and Drug Administration (US FDA) today said it has found that a plant owned by generic drugmaker Ranbaxy Laboratories to have falsified data and test results in approved and pending drug applications.
The Food and Drug Administration said it halted review of drug applications from Ranbaxy's Paonta Sahib plant in India.
The US FDA had earlier issued warning letters to Ranbaxy Laboratories Ltd, and an `import alert' for drugs from two Ranbaxy plants in India. The action, which affects over 30 different generic drugs, cites serious manufacturing deficiencies.
The US FDA had, in September last year, issued two warning letters to Ranbaxy Laboratories Ltd and an `import alert' for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India.
In the warning letters, the US regulator said it was ''concerned about deviations from US current Good Manufacturing Practice (cGMP) requirements at Ranbaxy's manufacturing facilities in Dewas and Paonta Sahib (including the Batamandi unit), in India.''
FDA had also issued an `import alert', under which US officials may detain at the US border, any active pharmaceutical ingredients (API) (the primary therapeutic component of a finished drug product) and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States.
''The problems at these two Ranbaxy plants relate to deficiencies in the company's drug manufacturing process. These actions are proactive measures that the FDA is taking in order to assure that all drugs that reach the American public are manufactured according to cGMP requirements,'' the agency said.
While this action does not involve removing products from the market, FDA said it had no evidence to date that Ranbaxy has shipped defective products and said it would continue to monitor the situation.
Today's announcement does not impact products from Ranbaxy's other plants which are not affected by the September actions. FDA had inspected those facilities and, had found them to be meeting US cGMP requirements for drug manufacturing.