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.
According to market estimates, the U.S. market for Mycophenolate Mofetil is around $30 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 is an India-based biopharma company and one of the leading global developers and manufacturers of select fermentation-based APIs across Immunosuppressants and oncology.
| Company Name | CMP |
|---|---|
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| Dr. Reddys Lab | 1277.80 |
| Cipla | 1400.70 |
| Zydus Lifesciences | 1088.90 |
| Lupin | 2268.10 |
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