Sun Pharma gets CDSCO Panel nod to manufacture, market Progesterone SR Tablet

Written by Dr. Divya Colin Published On 2022-10-11T18:00:38+05:30 | Updated On 11 Oct 2022 6:00 PM IST

Sun Pharma gets CDSCO Panel nod to manufacture, market Progesterone SR Tablet

New Delhi: The drug major Sun Pharma has got green signal from the Subject Expert Committee (SEC) functional under 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 their 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 in the body slowly over an extended period of time. It allows 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 treatment of secondary amenorrhea, dysfunctional uterine bleeding, and endometriosis, for 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.

Also Read:JnJ gets CDSCO Panel nod to study antipsychotic drug Paliperidone Palmitate

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Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.