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).

According to market estimates, the U.S. market for Tofacitinib Tablets both strengths put together is approximately US$ 500 million. The approval positions the Company to capitalize on these attractive market opportunities, enhance its product offerings, and support its long-term growth strategy across the U.S. and international markets.