Both the active pharmaceutical (API) and the formulation plants in India that Ranbaxy Laboratories planned to use to manufacture the long-delayed generic of Novartis' ($NVS) blood pressure drug Diovan are under FDA import alerts. But the Indian drugmaker has finessed a manufacturing workaround with the agency to make the heart drug at its Ohm Laboratories plant in New Jersey.
FDA spokesman Christopher Kelly said in an email that the agency approved the Ohm Laboratories plant to make valsartan, the generic of Diovan, in 40 mg, 80 mg, 160 mg and 320 mg doses. The New Jersey plant is the only FDA-approved Ranbaxy plant that has escaped bans for sales in the U.S. Bill Winter, vice president of North American sales for Ranbaxy, said in a statement Friday that the drug will be launched "as soon as sufficient supplies are manufactured to meet the needs of the market."
While the Ohm plant will make the finished product, Kelly said Ranbaxy would not disclose who was making the API, saying that was confidential commercial information. Kelly said, "The manufacturer of API used in the production of the finished product was inspected by the FDA prior to this approval and is not named in a consent decree or on Import Alert." A spokeswoman for Ranbaxy would say only that the API is not being made at the Ohm plant. That suggests that Ranbaxy is getting the API from an outside supplier because its own plant previously slated to make the API was banned by the FDA in January due to quality lapses.
Diovan went off patent in September 2012, before the FDA had banned Ranbaxy's formulation plant in Mohali or its API plant in Toansa that were to play a part in manufacturing of the drug. By then, the agency had already identified issues at Mohali and the drug was not approved for production. In September 2013, the FDA said a consent decree covering Ranbaxy plants in Dewas and Paonta Sahib would be extended to Mohali after inspections in 2012 "identified significant CGMP violations at Ranbaxy's Mohali facility, including failure to adequately investigate manufacturing problems and failure to establish adequate procedures to ensure manufacturing quality."
The delay has been great for Swiss drugmaker Novartis which reported Diovan sales of $1.7 billion in the U.S. last year. It has been unfortunate for consumers, and for other generic makers who have had to wait for Ranbaxy's 180 day exclusivity to run before they can get their own versions of the drug to market. Last week's approval will cut that windfall short for Novartis and ultimately be a boost for Sun Pharmaceutical. In April, Sun said it would buy Ranbaxy in a $3.2 billion stock deal with shareholders of the generic drug maker, including Daiichi Sankyo, which controls about 60% of the company. It said its top priority is to get Ranbaxy's four FDA plants currently banned by the FDA up to standards so they can again ship products to the U.S.
- here's the Ohm Laboratories announcement