Concord Biotech shares gained 5.8 per cent on BSE, logging an intra-day high of ₹1,235 per share, after the company received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (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.
The US market for Mycophenolate Mofetil is estimated at approximately $30 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.
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.
Concord Biotech is focused on driving sustainable growth through its differentiated fermentation-based capabilities — a technically complex and high-barrier manufacturing process — positioning it as a specialised player in the global API and formulations market.
Source link
#Concord #Biotech #jumps #USFDA #approves #Mycophenolate #Mofetil #ANDA
