New Delhi: India’s largest drug company said one of its plants that was blacklisted by the United States has been given approval by British and Australia regulators.
The US Food and Drug Administration (FDA) said in February that New Delhi-based generics giant Ranbaxy had “falsified data and test results in approved and pending drug applications.”
But a statement issued late on Monday by the firm said the plant had been given Good Manufacturing Practice certificates by Britain’s Medicines and Healthcare Regulatory Agency and Australia’s Therapeutic Goods Administration.
The British approval will cover new product applications for Britain and also apply to product applications for the rest of the European Union, Ranbaxy added.
The announcement came as a boost for Ranbaxy’s beleaguered Japanese owners, Daiichi Sankyo, which has seen the value of its investment sink in Ranbaxy as a result of a flurry of bad regulatory news. Daiichi Sankyo is Japan’s third-largest drugmaker.
The FDA suspended evaluations of any new or pending drug approval applications containing data supplied by the suspect plant in northern Himachal Pradesh state until the matter was sorted out.
Ranbaxy, which has said it will study the FDA’s allegations, has promised to work with the agency to clear its name.