Ranbaxy Files ANDA to Sell Generics to U.S. from Only Facility Not Banned
India's Ranbaxy Laboratories had filed ANDAs with the FDA seeking to sell generic drugs made at its Gurgaon facility to the U.S. market.
Ranbaxy's Gurgaon location is currently the only one of its five facilities not banned from supplying medicines to the U.S. market. However, it appears as though Ranbaxy is maintaining that Gurgaon is home to research and development centers but no manufacturing facility. Industry sources told Business Standard that Ranbaxy’s Gurgaon plant had a pilot manufacturing line that the company could scale up for commercial use in the event of secured product approvals.
Ranbaxy, which was acquired by competitor Sun Pharma in April in a 3.2 billion dollar deal, currently can only sell drugs to the U.S. market through its New Jersey-based subsidiary, Ohm Laboratories.
Read the Business Standard article