In an effort to resume imports of its generic drugs, Indian drug maker Ranbaxy Laboratories LTD has filed a corrective action plan with the U.S. Food & Drug Administration (FDA). The FDA barred some of Ranbaxy’s drugs from import to the U.S because of concerns about the safety of medications made at some of its overseas plants.
Based in India, Ranbaxy is one of the 10 largest generic-drug producers in the world and has been operating in the States since 1995. It has been involved in several scandals over the past year. As we reported last September, the FDA had imposed an import ban on 30 different Ranbaxy drugs because of the agency’s concerns about the “seriousness and extent” of violations of manufacturing standards at its Paonta Sahib plant and a second Ranbaxy facility in India. At the time, officials said they were concerned about whether the practices employed at the facilities could ensure purity of drugs they made. (more…)
