Indian drugmaker Ranbaxy Laboratories has reached a settlement with the U.S. Food and Drug Administration after the agency said Ranbaxy manufacturing plants didn’t meet national standards. According to BBC News, the Justice Department filed the proposed settlement in a federal court in Maryland Thursday.
Ranbaxy has already seen 30 of its drugs banned from sale in the United States due to problems in quality control. In 2008, the FDA found manufacturing defects at two of the company’s Indian plants. A year later, the agency alleged that one of these Ranbaxy sites had falsified data in its drug applications. Since then, the FDA has refused to review any new products from Ranbaxy under fears that information regarding shelf-life may be incorrect.
A subsequent government investigation found that Ranbaxy failed to ensure that sterile drugs were not contaminated during manufacturing.
If the settlement is approved, Ranbaxy agrees to have a third party review of both its facilities and the data it gives the FDA. Ranbaxy has already issued a statement saying it is ready to “comply with current good manufacturing practices.” The resulting delay in production could last 12 to 18 months, the BBC said.
Until the settlement is approved and the company makes these changes, the FDA is holding Ranbaxy on permanent injunction.
