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Unichem receives US FDA nod for pain killer piroxicam capsule

It will commercialise the product from its Goa plant & source API from its API plant in Roha

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Last Updated : Apr 18 2017 | 11:33 AM IST

Unichem Laboratories Limited has received ANDA approval from the US Food and Drug Administration (USFDA) for pain killer drug piroxicam capsule (10 mg & 20 mg). The approved product is a generic version of Feldene capsules of Pfizer Inc.

Piroxicam, a nonsteroidal anti-inflammatory drug (NSAID), is used to relieve some symptoms caused by osteoarthritis (arthrosis, degenerative joint disease), rheumatoid arthritis and ankylosing spondylitis (rheumatism of the spine), such as swelling, stiffness and joint pain.

While Unichem will commercialise the product from its Goa plant, it will source the active pharmaceutical ingredient (API), used to make the formation, from its API plant in Roha (Maharashtra).