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livzon Group's injectable acetic acid secukinumab has been approved for marketing by the US FDA, and the first batch of products has been shipped.
Release time:
2024-04-28
Recently, Livzon Group received the ANDA approval notice issued by the U.S. Food and Drug Administration (ANDA No.: 214540), approving the company's research and development of injectable Acetate Cetrorelix for sale in the United States.This morning, the first batchof injectable Acetate Cetrorelix has been shipped to the United States.
This timeinjectable Acetate Cetrorelix has been approved for sale in the United States,marking that Livzon Group is qualified to sell this product in the U.S. market as a pharmaceutical, which will have a positive impact on the company's expansion into overseas markets.
Injectable Acetate Cetrorelix isa formulation product developed in collaboration between Livzon Group and Nanjing Jianyou.This product is a third-generation gonadotropin-releasing hormone antagonist (GnRH-ant), which has the advantages of rapid onset of action and low incidence of OHSS and adverse events. The product was approved for sale in China on December 31, 2021, and registration applications have been submitted in several overseas countries.
In recent years, Livzon Group has been continuously deepening its efforts in the global pharmaceutical market, enhancing its international influence, and gradually moving towards the top of the industrial value chain. From non-sterile active pharmaceutical ingredients to sterile active pharmaceutical ingredients, from active pharmaceutical ingredients to formulations, Livzon Group's exports have been continuously upgraded in quality, broadening its "circle of friends." As of now, Livzon Group's products in assisted reproduction, gastrointestinal, and anti-infection areas are continuously being sold and registered in multiple countries such as Pakistan, Indonesia, the Philippines, and Uzbekistan, with more than 20 formulation products having completed registration approval in several overseas countries, and several varieties having submitted registration applications in more than 10 countries and regions including Pakistan, Indonesia, the Philippines, Thailand, Vietnam, Malaysia, Uzbekistan, Russia, and the Hong Kong and Macau regions of China.
Livzon Group is actively exploring diversified cooperation in overseas markets, and at this stage has cooperated with multiple countries in Asia, Africa, and Latin America for formulation registration work, and is actively discussing international market cooperation with international medical giants and world-renowned pharmaceutical companies as well asinternational leadingpartners in the field of assisted reproductive drugs to further enhance the product's market share in the international market.
In the future, Livzon Group will drive development through innovation, uphold the mission of "patient quality of life first," continuously enhance its competitiveness in the international market, and strive to provide more safe, effective, reliable quality, and clinically accessible new drugs to benefit global patients, contributing to human health.
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