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ST Renfu: Injection of Estradiol Cypionate Obtains a U.S. FDA Approval Number
ST Renfu Announcement, its subsidiary Humanwell Pharmaceutical US, Inc. has received the approval number from the U.S. Food and Drug Administration (FDA) for injectable Cetrorelix Acetate. Injectable Cetrorelix Acetate is used in assisted reproductive technology for women undergoing controlled ovarian stimulation to prevent premature luteinizing hormone (LH) surge. Yichang Renfu Pharmaceutical USA submitted the ANDA application to the FDA in September 2024 and it has been accepted. As of now, the total R&D investment is approximately $1.2 million. According to IMS database statistics, the sales revenue of injectable Cetrorelix Acetate in the U.S. market in 2025 is about $97 million. Major manufacturers include EMD SERONO INC (original research), Qilu Pharmaceutical Co., Ltd., Livzon Pharmaceutical Group Inc., and others.