Unichem Laboratories has received ANDA approval from the United States Food and Drug Administration (USFDA) for Unichem's Tramadol Hydrochloride Tablets USP, 50 mg. to market a generic version of Ultram Tablets, 50 mg, of Janssen Pharmaceuticals, Inc. which are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The Product will be commercialized from the company’s Ghaziabad plant.
Unichem Laboratories is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India and several other markets across the world.
