News

Concord Biotech announced that the 41th Annual General Meeting(AGM) of the company will be held on 31 July 2026.

Concord Biotech announced the successful completion of inspection by the Pharmacy and Poisons Board (PPB) from Kenya and the National Drug Authority (NDA) from Uganda at Unit-II formulation facility. The inspection took place from 18 June 2026 to 24 June 2026, and was concluded successfully.

Concord Biotech announced the successful completion of an ANVISA inspection conducted by the Brazilian Health Regulatory Agency at the company`s API manufacturing facility in Limbasi. The inspection took place from 08 June to 12 June 2026, and was concluded successfully.

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.

Concord Biotech has received approval from the U.S. Food and Drug Administration (USFDA) for its ANDA for Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL. Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.