Unichem Laboratories Limited has announced that it has received ANDA approval for its Celecoxib capsules, 50 mg, 100 mg, 200 mg, and 400 mg from the United States Food and Drug Administration (FDA) to market a generic version of celebrex (Celecoxib) capsules of G.D. Searle LLC, Division of Pfizer Inc.
Celecoxib capsules are indicated for treatment of osteoarthritis, rheumatoid arthritis juvenile rheumatoid arthritis, ankylosing spondylitis, acute pain and primary dysmenorrhea.
The product will be commercialized from Unichem's Goa Plant.
Unichem Laboratories Limited 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 several markets across the world.