Sun Pharma Progesterone injection secures CDSCO panel okay
New Delhi: Pharmaceutical major, Sun Pharma, has got a go-ahead from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) for the manufacturing and marketing of the drug Progesterone Injection, 22.35 mg per ml.
This came after the drug-maker presented a comparative bioavailability study report in accordance with the earlier SEC recommendation.
Therapeutic Progesterone is the therapeutic form of the naturally occurring hormone progesterone that occurs naturally in females, and is essential for endometrial receptivity, embryo implantation, and the successful establishment of pregnancy.
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Progesterone is used in various contraceptive preparations to prevent ovulation and fertilization, as well as in other formulations to promote and support pregnancy.
Pharmaceutical progesterone is derived from a plant source and is chemically similar to progesterone derived from human ovarian tissue. Progesterone is available in a variety of forms, including gelatinized capsules, vaginal gel, tablets, vaginal inserts, and injectables, all of which are used for different purposes. Last year, the firm presented the proposal for Progesterone Injection 50mg/2.237ml. Following this, the committee noted that Progesterone 50mg Aqueous injection is not approved anywhere globally.
Accordingly, at the 49th SEC meeting for Reproductive & Urology, held on 26.02.2020, the committee opined the firm to conduct a comparative bioavailability study with Progesterone 50 mg aqueous injection (s.c) vs Progesterone 50 mg oil-based injection (i.m) for clinically relevant pharmacokinetic parameters.
As a result, Sun Pharma presented its proposal, together with the comparative bioavailability study protocol, at the 53rd SEC meeting for Reproductive & Urology on September 23, 2020, which was subsequently approved by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO).
Now, in continuation, at the recent SEC meeting for Reproductive & Urology, the committee extensively evaluated the comparative bioavailability study report presented by Sun Pharma.
After detailed deliberation, the committee recommended the grant of permission for the manufacture and marketing of the drug Progesterone Injection at 22.35 mg per ml with an already approved indication.
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