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Concord Biotech gets USFDA’s nod for Tofacitinib Tablets

10 Jun 2026 Evaluate

Concord Biotech has received approval from the U.S. Food and Drug Administration (USFDA) for its ANDA for Tofacitinib Tablets, 5 mg and 10 mg. Tofacitinib tablets are indicated for the treatment of adult patients with Moderately to severely active rheumatoid arthritis (RA), Active psoriatic arthritis (PsA), Active ankylosing spondylitis (AS), Moderately to severely active ulcerative colitis (UC), Active PsA, Active polyarticular course juvenile idiopathic arthritis (pcJIA).

The approval positions the company to capitalize on attractive market opportunities, enhance its product offerings, and support its long-term growth strategy across the U.S. and international markets.

Concord Biotech is an India-based biopharma company and one of the leading global developers and manufacturers of select fermentation-based APIs across Immunosuppressants and oncology.

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