Synokem Pharma Gets CDSCO Panel Nod to Study Dydrogesterone SR Tablet
New Delhi: The drug major Synokem Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to initiate Phase III clinical trial of Dydrogesterone sustained-release tablets (SR) Tablet 20mg.
This came after Synokem Pharmaceuticals presented the bioequivalence study report of Dydrogesterone sustained-release tablets 20mg before the committee.
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 helps to regulate the healthy growth and normal shedding of the uterus lining. Therefore, it may be useful in the treatment of menstrual disorders such as absent, irregular, or painful menstrual periods, infertility, premenstrual syndrome, and endometriosis.
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