Concord Biotech share rises 6% after USFDA clears Tofacitinib Tablets ANDA

Concord Biotech shares jumped 5.8 per cent on BSE after USFDA cleared Tofacitinib Tablets ANDA

Concord Biotech shares jumped 5.8 per cent on BSE, logging an intraday high at ₹1,346.2 per share. The stock was in demand after the company received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Tofacitinib Tablets. 

At 10:51 AM, Concord Biotech’s share price pared some gains and was up 4.38 per cent at ₹1,327.25 per share. In comparison, the BSE Sensex was up 0.57 per cent at 74,340.79. 

“We are pleased to inform 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,” the filing read. 

 

Tofacitinib tablets are indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active ulcerative colitis, and active polyarticular course juvenile idiopathic arthritis. 

The combined US market for Tofacitinib Tablets across both strengths is estimated at approximately $500 million, according to market estimates. The approval positions Concord Biotech to capitalise on this opportunity, strengthen its product portfolio, and support its long-term growth strategy across the US and international markets.  READ | Muthoot Finance slips 4%, at 9-month low; what's making Street nervous? 

Recently, the company received approval from USFDA for its ANDA for Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL. 

Mycophenolate Mofetil is an antimetabolite immunosuppressant indicated for the prevention of organ rejection in adult and paediatric patients aged three months and above who have received allogeneic kidney, heart, or liver transplants, in combination with other immunosuppressants. 

Concord Biotech is a research and development-driven biopharmaceutical company specialising in the manufacturing of fermentation-based active pharmaceutical ingredients (APIs) and formulations. The company leverages its technical expertise and advanced manufacturing processes to produce high-quality pharmaceutical products for global markets. 

The company's manufacturing facilities are approved by leading global regulatory authorities, operating in compliance with the highest standards of quality and good manufacturing practices (GMP). This regulatory track record enables the company to consistently meet international quality benchmarks across its product portfolio.