Ranbaxy gets U.S. regulator's approval to sell anti-HIV drug

Tuesday, 01 July 2003, 19:30 IST
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NEW DELHI: Ranbaxy Laboratories, India's largest drug maker by sales, Monday said it had got the approval of the U.S. Food and Drug Administration (FDA) to manufacture and market an anti-HIV drug in the U.S. The product, Ganciclovir capsules, will be made available for sales, marketing and distribution in the U.S. through Ranbaxy's wholly owned subsidiary Ranbaxy Pharmaceuticals Inc., said a company statement issued here. Ranbaxy Pharmaceuticals Inc. will launch the product in the U.S. market as soon as inventories are achieved to support customer requirements, the statement added. The product will be offered through all classes of trade including wholesalers, chain pharmacies and generic distributors that support the dispensing and therapeutic usage of this product. "The opportunity to market Ganciclovir prior to patent expiry is a result of coordinated efforts amongst our scientists, business and legal teams," said Ranbaxy Pharmaceuticals Inc president Dipak Chattaraj. "Ranbaxy is now in an exclusive position to market this product for six months in the U.S. healthcare system providing an affordable, generic form of Ganciclovir," he added. Based in New Jersey, Ranbaxy Pharmaceuticals Inc. started operations in the U.S. in 1994 and launched its first prescription product in January 1998, following FDA approval in August 1997. For the year 2002, U.S. operations achieved sales of $296 million, a growth of 162 percent over the corresponding year. The company markets a range of generic products covering major therapeutic areas.
Source: IANS
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