Recently, Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group, received a drug registration certificate for Milrinone Lactate Injection issued by the Malaysian Food and Drug Administration ( NPRA ), marking that the product has officially obtained market access in Malaysia and can be sold and commercialized there.

Milrinone lactate injection is a phosphodiesterase inhibitor with both positive inotropic and vasodilatory effects. It is a drug that rapidly improves hemodynamics and is suitable for acute and chronic refractory congestive heart failure caused by ineffective or poorly responded treatment with digitalis, diuretics, and vasodilators. Currently, milrinone lactate injection produced by Lunan Pharmaceutical has been approved for marketing in the United States, Ukraine, Costa Rica, and other countries. Furthermore, marketing applications have been submitted in more than 20 countries and regions, including Vietnam, Saudi Arabia, Brazil, and the United Kingdom.

During the product's marketing application process in Malaysia, the R&D team strictly adhered to local regulations, efficiently prepared technical documentation, responded to multiple rounds of review requests and supplementary information, and actively promoted the product's priority review and approval status. The approval of Lunan Pharmaceutical's Milrinone Lactate Injection as the first generic product in Malaysia provides local cardiovascular disease patients with a high-quality treatment option and lays a solid foundation for subsequent market access and commercial cooperation for other products.

Established in 2017 , the International Drug R&D Center serves as a window for Lunan Pharmaceutical Group's internationalization. Adhering to the internationalization strategy of "based in China, radiating globally," it has currently obtained 34 formulation approvals in China, the US, and Europe, 75 formulation approvals in emerging markets , and 8 CEP certificates ; it has also submitted over 40 DMF ( Drug Manufacturing File) applications in Europe, the US, and Japan , and over 50 DMF applications in other emerging markets . With the development and launch of more products, the company will accelerate its pace in the international market, enhance Lunan Pharmaceutical's brand image and reputation both domestically and internationally, and lay the foundation for "Lunan Pharmaceutical's Healthy World ."

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