Unichem Laboratories receives ANDA approval
Unichem Laboratories on Tuesday informed the bourses that it 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. The medication is indicated for the management of severe pain that requires an opioid analgesic and for which alternative treatments are inadequate.
On Monday, the company also informed that it has received ANDA approval from USFDA for Unichem's Chlorthalidone Tablets USP, 25 mg and 50 mg to market a generic version of Hygroton Tablets, 25 mg and 50 mg of Sanofi Aventis US, LLC.
These both products will be commercialised 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.
On Tuesday, the stock of Unichem Lab settled for the day on a positive mark of Rs. 180 apiece, up by nearly 1.12 per cent from its previous close.