Concord Biotech Limited has received approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Tofacitinib Tablets in two strengths: 5 mg and 10 mg.
The 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 polyarticular course juvenile idiopathic arthritis (pcJIA)
According to market estimates, the U.S. market for Tofacitinib Tablets (both strengths combined) is approximately US$ 500 million.
The company states that this approval positions it to capitalize on these market opportunities, enhance its product offerings, and support its long-term growth strategy across the U.S. and international markets. The approval is in line with Concord Biotech's growth strategy and will strengthen the company's position in the U.S. market.
The disclosure was made pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, 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.
The document was signed by Paritosh Trivedi, Company Secretary & Compliance Officer (ACS 63623) on June 10, 2026, at 10:02:39 IST.