Concord Biotech jumps 8% after USFDA approves Mycophenolate Mofetil ANDA

Concord Biotech 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.

Concord Biotech shares gained 8.3 per cent on BSE, logging an intra-day high of ₹1,264.45 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.

 

However, at 10:56 AM, Concord Biotech’s share price pared some gains, but was up 5.87 per cent at ₹1,235.25 per share. In comparison, the BSE Sensex was down 1.14 per cent at 73,801.53. The stock has rallied for the third consecutive session, surging around 20 per cent. 

 

“We are pleased to inform that the company has received approval from the USFDA for its ANDA for Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL,” the filing read.

 

 

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.

Technical view 

"Concord Biotech is showing encouraging signs of a trend reversal after a prolonged corrective phase. The stock has rebounded strongly from the major support zone of ₹1,130–1,150 and recently witnessed a sharp bullish move with improved volumes, indicating fresh accumulation. Prices have moved above the short-term moving averages, while the RSI has climbed above 60, reflecting strengthening momentum and improving buying interest. Notably, the stock is approaching a long-term descending trendline resistance near ₹1,280–1,320," said Virat Jagad, sr. technical research analyst, Bonanza.  He added: A decisive breakout and sustained close above this zone could trigger a fresh uptrend towards ₹1,450 and ₹1,600. On the downside, ₹1,130 remains a crucial support level, and holding above it would keep the bullish recovery structure intact. Overall, the technical setup has improved significantly, with momentum and price action favoring a positive medium-term outlook.  Disclaimer: View and outlook shared on the stock belong to the respective brokerages and are not endorsed by Business Standard. Readers discretion is advised.