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Synokem gets CDSCO panel nod to study Dyhydogestrone as part of Assisted Reproductive Technology

admin by admin
March 12, 2023
in Pharmaceutical


Furthermore, in connection with the bioequivalence study, the firm state, “An open-label, randomized, balanced, two-treatment, two sequences, two-period, cross-over, single dose, oral bioequivalence study of Dydrogesterone film coated sustained release 30mg tablets (T) manufactured by Synokem Pharmaceuticals Ltd., India with Duphaston (Dydrogesterone tablets IP 10mg (Dose: 3x10mg) (R) manufactured by Abbott India Limited in normal healthy, adult female subjects under fasting condition.”

Duphaston 10mg Tablet manufactured by Abbott India treats female infertility, relieves various menstrual problems like heavy unusual menstrual bleeding or pain as well as irregular periods, Premenstrual syndrome (PMS) and endometriosis. It also restores normal menstrual cycles in case periods have stopped before reaching menopause.

Dydrogesterone is a synthetic progesterone for menstrual cycle regulation, infertility treatment, prevention of miscarriage, and other conditions. 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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Tags: Assisted Reproductive Technology treatmentbioequivalence studyCDSCOCentral Drug Standard Control OrganisationDyhydrogesterone film coated sustained release tabletsinfertility treatmentmenstrual cycle regulationPhase III clinical trialprevention of miscarriageSECSubject Expert CommitteeSynokem Pharmaceuticals
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