Last Updated on October 2, 2024 by The Health Master
New Delhi: The drug major Sun Pharma has got the green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market the Progesterone Sustained Release (SR) Tablets (200/300/400mg).
This came after the firm presented its proposal along with the bioavailability (BE) study report of Progesterone Sustained Release tablet 400mg before the committee.
Sustained Release (SR) Tablets are designed to release a drug into the body over an extended period of time.
It allows the delivery of a specific drug at a programmed rate that leads to drug delivery for a prolonged period of time.
Progesterone is a hormone used for a variety of functions, including contraception, control of abnormal uterine bleeding, maintenance of pregnancy, and prevention of endometrial hyperplasia.
Progesterone binds and activates its nuclear receptor, PR, which plays an important part in the signaling of stimuli that maintain the endometrium during its preparation for pregnancy.
Progesterone may prevent pregnancy by changing the consistency of cervical mucus to be unfavorable for sperm penetration, and by inhibiting follicle-stimulating hormone (FSH), which normally causes ovulation.
Exogenous progesterone supplementation is given for the treatment of secondary amenorrhea, dysfunctional uterine bleeding, and endometriosis, for the management of luteal phase deficiency, for preventing preterm delivery, and also to prevent endometrial hyperplasia.
At the recent SEC meeting for Reproductive and Urology held on September 28th, 2022, the expert panel reviewed the proposal and the bioavailability (BE) study report of Progesterone SR Tablet 400mg presented by the drug major Sun Pharma.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market the applied drug products for an already approved indication.
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