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.

Dydrogesterone is an orally active progestogen that acts directly on the uterus, producing a complete secretory endometrium in an estrogen-primed uterus. At therapeutic levels, dydrogesterone has no contraceptive effect as it does not inhibit or interfere with ovulation or the corpus luteum.

At the recent SEC meeting for Reproduction and Urology held on 20 September 2023, the expert panel reviewed the bioequivalence study report and Phase III clinical trial study report of Dydrogesterone Extended Release tablet 20mg presented by the drug major Zydus Healthcare.

After detailed deliberation, the committee recommended the grant of permission to manufacture and market the Dydrogesterone Extended Release tablet 20mg.

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