Concord Biotech gets FDA nod for immunosuppressant mycophenolate mofetil

Concord Biotech gets FDA nod for immunosuppressant mycophenolate mofetil


Pharmaceutical company Concord Biotech Ltd on Tuesday (June 2) said it has received approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for mycophenolate mofetil for oral suspension USP, 200 mg/mL.

The company said mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and paediatric recipients aged three months and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.

According to market estimates cited by the company, the US market for mycophenolate mofetil is approximately $30 million. Concord Biotech said the approval is aligned with its growth strategy and is expected to strengthen the company’s position in the US market.

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The company added that the approval will help enhance its product offerings and support its long-term growth strategy across the US and international markets.

Fourth quarter results

Concord Biotech reported a 36.8% drop in fourth-quarter earnings, with net profit falling to ₹88.8 crore from ₹140.4 crore in the corresponding quarter last year, impacted by lower revenue and margin contraction.

The R&D-driven biopharmaceutical company said its revenue from operations declined 24.1% to ₹326.1 crore compared with ₹429.9 crore a year ago. Earnings before interest, taxes, depreciation, and amortisation (EBITDA) for the quarter fell 37.8% year-on-year to ₹118.5 crore, while the EBITDA margin narrowed to 36.4% from 44.3% in the year-ago period.

ALSO READ | Citi initiates coverage on Concord Biotech with ‘Buy’ call; sees up to 24% upside

The board had recommended a dividend of ₹7.55 per equity share of face value ₹1 each for FY26, subject to shareholder approval, at the upcoming annual general meeting. The company has fixed July 24, 2026, as the record date for determining eligible shareholders for the dividend payout.

Shares of Concord Biotech Ltd ended at ₹1,166.80, up by ₹106.20, or 10.01%, on the BSE today, June 2.

 



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