Recently, Hebei Changshan Biochemical Pharmaceutical Co., Ltd. (stock abbreviation: Changshan Pharmaceutical, stock code: 300255 ) reached a significant milestone – the ANDA application for the generic version of its core drug, enoxaparin sodium injection , was officially approved by the U.S. Food and Drug Administration ( FDA ), with ANDA number 218775. This marks the first time Changshan Pharmaceutical's heparin preparations have passed FDA certification in the United States, signifying that the company's product quality has aligned with international standards and successfully obtained its "ticket" to enter the U.S. market.

As a commonly used antithrombotic drug in clinical practice, enoxaparin sodium injection has indications covering multiple key scenarios: prevention of venous thromboembolic diseases associated with orthopedic and general surgery, reducing the risk of postoperative thrombosis; treatment of existing deep vein thrombosis (including cases with non-severe pulmonary embolism, excluding pulmonary embolism requiring surgery or thrombolytic therapy); treatment of unstable angina and non-Q wave myocardial infarction in combination with aspirin; and suitability for extracorporeal circulation in hemodialysis to prevent thrombosis, providing multi-dimensional protection for patient treatment. The newly approved injectable formulations cover seven mainstream strengths (30mg/0.3mL, 40mg/0.4mL, 60mg/0.6mL, 80mg/0.8mL, 100mg/1mL, 120mg/0.8mL, and 150mg/1mL), fully meeting diverse clinical needs.

This FDA approval is of great significance to Changshan Pharmaceutical. On the one hand, it confirms the company's technological strength in the research and development and production of heparin preparations, further enhancing the international competitiveness of its products; on the other hand, it opens a key channel for the company to expand into overseas markets and helps promote its globalization strategy.
In the future, Changshan Pharmaceutical will continue to focus on pharmaceutical research and development and production, actively promote the overseas market entry of approved products, and strictly control product quality to serve patients around the world with high-quality pharmaceutical products.

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