Ranbaxy Laboratories may be dealing with more regulatory issues for its plant in Mohali, and they may be interfering with it getting generic Diovan to market.
India's Business Standard, citing sources, says Ranbaxy received a Form 483 from the FDA several months ago following an inspection of supplies of valsartan, the generic of Diovan. A Ranbaxy spokesman declined to comment to FiercePharma about whether a Form 483 had been issued for the plant but did say in an email, "We continue to make regulatory submissions from Mohali and will commercialize products from Mohali when we get approvals. As well, and with respect to Valsartan, we continue to work with the FDA to gain approval for this molecule."
Diovan went off patent in September, and the publication says the Indian generics maker was forecast to generate $187 million during the 6-month exclusivity. Mylan ($MYL) tried a couple of times to get the FDA to cancel the exclusivity since Ranbaxy's drug had yet to be approved, but it was turned back in those efforts. Ranjit Kapadia, an analyst with Centrum Broking, said it remains unclear when the drug will be launched. Given competition from other drugs, he said he thinks Ranbaxy's sales of valsartan will be cut in half.
Last month, Ranbaxy pleaded guilty to 7 felonies and agreed to pay $500 million after admitting that 5 years ago it was manufacturing subpar drugs and lying about it to U.S. regulators. The company is operating under a 5-year consent decree. The May agreement has generally settled the matter in the U.S., but it has opened a debate in India about whether regulators there should have acted on the information, sparking an inquiry now.
- read the Business Standard story