Recently, Suzhou Lixin Pharmaceutical Co., Ltd. received a notification from the U.S. Food and Drug Administration (FDA) that "the raw material drug of pemetrexed disodium has completed a comprehensive scientific review and fully supports the ANDA marketing application of the preparation". The FDA review shows that the product quality and R&D technology capability of the pemetrexed disodium API produced by Lixin Pharmaceutical have been recognized by the US regulatory market. The image and brand of the whole industry chain play a decisive role. Name of

Name of raw material: Pemetrexed disodium 2.5 water

DMF number: 025640 Holder: Suzhou Lixin Pharmaceutical Co., Ltd.

Pemetrexed disodium is an antifolate preparation containing a pyrropyrimidine structure, which destroys the intracellular folic acid dependence Normal metabolic process, inhibit cell replication, thereby inhibiting tumor growth. Lixin Pharmaceutical actively promotes the high-quality development of raw materials and vigorously deploys the global market. Currently, pemetrexed disodium 2.5 water and 7 water have been approved for marketing in China and Europe.

Lixin Pharmaceutical has been adhering to the implementation of global norms, strengthensing international cooperation, international registration, and international certification, and has passed the certification of FDA, EDQM, EMA, PMDA and other authoritative organizations for many times. The company will actively increase the intensity of international certification and registration, continue to play the advantages of internationalization, and expand the international market.