Xianju Pharmaceutical’s progesterone vaginal sustained-release gel drug registration application has been accepted

News from the Beijing News On August 4, Xianju Pharmaceutical announced that it has recently received a notice of acceptance of the domestically produced drug registration of progesterone vaginal sustained-release gel issued by the State Food and Drug Administration.

Progesterone vaginal sustained-release gel, specification 8% (90mg). Progesterone Vaginal Sustained-Release Gel was originally developed by Columbia Laboratories, Inc under the trade name Crinone®. Indications: Assisted reproductive technology, 8% is indicated for progesterone supplementation and replacement as part of assisted reproductive technology for women who are infertile due to progesterone deficiency. Columbia’s progesterone vaginal extended-release gel has been approved in several countries and is licensed to Merck Serono outside the US for progesterone supplementation in assisted reproduction. In 2008, it was approved for import registration in China for the first time, with a specification of 8% (90mg), which is used for the supplementary treatment of progesterone in assisted reproductive technology. Currently, the twenty-seventh batch of generic drug reference preparations is recommended as a reference preparation.

The specifications of the progesterone vaginal sustained-release gel declared by the company are consistent with the specifications of the original research that have been approved for marketing, and are declared as 4 categories of chemicals.

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