Pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, Concord Biotech has informed that the Company 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. The requisite details of terms of the provisions of Regulation 30 read with Schedule III and SEBI Master Circular no. SEBI/HO/CFD/PoD2/CIR/P/0155 dated November 11, 2024 read with Master Circular no. HO/49/14/14(7)2025-CFD-POD2/I/3762/2026 issued on July 11, 2023 and last updated on January 30, 2026 are enclosed.
The above information is a part of company’s filings submitted to BSE.
