Ranbaxy Laboratories had filed applications seeking to sell drugs in the US made at its Gurgaon plant, which is not on among those barred by the the US Food and Drug Administration (FDA), according to a company executive who did not wish to be named. “Ranbaxy has five manufacturing facilities in India that are registered with the FDA: Paonta Sahib, Mohali, Toansa, Gurgaon, and Dewas,” the US drug regulator’s spokesperson told Business Standard. Four of these are barred from supplying medicines to the US market but the Gurgaon plant is on the FDA approved list. A Ranbaxy executive said Abbreviated New Drug Applications (ANDAs) were recently filed from the Gurgaon facility seeking the FDA’s approval to sell generic medicines in the US. “The FDA does not discuss communications with pharmaceutical companies,” the FDA spokesperson said when asked about Ranbaxy’s filings from its Gurgaon plant.
|RANBAXY’S TROUBLED PAST|
Ranbaxy, which was bought over by Mumbai-based Sun Pharma in a $4 billion deal in April, sells drugs in the US only manufactured at its New Jersey-based wholly owned subsidiary Ohm Laboratories. Ranbaxy has some fat ANDA filings with potential “first to file” rights pending with the FDA that could earn significant revenue during the 180 days of exclusive sales in the world’s largest drug market. Though there is a delay in FDA approvals, the Ranbaxy management is confident about retaining sales exclusivity on its pending applications. Besides, the company indicated it recently filed applications for 10 new generic drugs with the FDA. The FDA allows import of drugs from its approved plants and from units that make the ANDA filings. During the quarter ended March 31, Ranbaxy posted Rs 770 crore sales in the US, up 19 per cent from a year ago. But the company’s sales in the US declined by $22 million from the previous quarter, mainly due to the ban on supplies from the Toansa facility. Observers are hopeful that under Sun Pharma’s management, Ranbaxy will resolve its regulatory issues in the US market. On Wednesday, shares of Ranbaxy ended at Rs 460 on the BSE, up 0.89% from their previous close.