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Development and manufacturing partner Mithra can synthesise E4 at scale through a complex plant-based production process
April 16, 2020
By: Contract Pharma
Contract Pharma Staff
Mayne Pharma has submitted an NDA to the U.S. FDA seeking marketing authorization for E4/DRSP, a combined oral contraceptive indicated for the prevention of pregnancy. E4/DRSP is a novel, next-gen oral contraceptive containing Estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg. E4 is a naturally occurring estrogen that is produced by the human fetal liver during pregnancy. Following more than 20 years of research and development, Mayne Pharma’s development and manufacturing partner Mithra...
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