Zydus Healthcare gets CDSCO Panel Nod To Manufacture, Market Dydrogesterone Extended Release Tablet
New Delhi: The drug major Zydus Healthcare has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market the synthetic progesterone, Dydrogesterone Extended Release Tablet 20mg.
This came after Zydus Healthcare presented a bioequivalence (BE) study report and Phase III clinical trial study report of Dydrogesterone Extended Release tablet 20mg before the committee.
Dydrogesterone is a synthetic progesterone for menstrual cycle regulation, infertility treatment, prevention of miscarriage, and other conditions.
Dydrogesterone is a progestogen (a synthetic form of progesterone hormone) used to treat progesterone deficiency (irregular periods, etc.) and other symptoms due to the increased activity of estrogen. It belongs to the 'hormonal replacement therapy' group of medicines.
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