Ranbaxy corrective action plan under review : FDA
The corrective plan submitted by Ranbaxy Laboratories is being reviewed by US health regulator Food and Drug Administration (FDA) after some of its medicines manufactured in India were banned. Ranbaxy has been operating in United States since 1995.
Ranbaxy, one of the 10 largest generic-drug producers in the world, said in March that drugs from that plant were approved for sale in the UK and Australia after a joint audit by regulators.
US FDA spokesperson Christopher C Kelly said that the FDA is working very closely with the firm to ensure that all the Ranbaxy products currently in the US market are safe and effective.
He added that FDA received the Corrective Action Operating Plan (CAOP) from Ranbaxy on May 18, 2009. The CAOP is currently under review by the Center for Drug Evaluation and Research's Office of Compliance.
After reviewing the plan FDA will take actions identified in CAOP.
Last year in September FDA banned the import of 30 generic drugs manufactured at company's plants located in Dewas in Madhya Pradesh and Poanta Sahib in Himachal Pradesh.
Company officials believe that the full approval process by the FDA will take months.