Beijing News (Reporter Liu Xu) Lunan Pharmaceutical Group announced on its official WeChat account this week that the company has received the approval letter for the Abbreviated New Drug Application (ANDA) for Milrinone Lactate Injection in the United States. This marks the first injectable product from Lunan Pharmaceutical to be launched in the U.S. market, as well as the company's third formulation product to receive marketing approval in the United States.
Lactate Milrinone 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 suboptimal treatment with digitalis, diuretics, and vasodilators. Lactate Milrinone Injection (brand name: Lunan Likang) from Lunan Pharmaceutical won the Second Prize of National Science and Technology Progress Award in 2004 and passed the consistency evaluation approved by the National Medical Products Administration in 2022.
Lunan Pharmaceutical stated that the approval and market launch of Milrinone Lactate Injection in the U.S. indicate that the product quality fully complies with U.S. pharmaceutical quality and cGMP requirements.
To advance its internationalization strategy, Lunan Pharmaceutical began establishing an International Drug Research and Development Center in 2017, focusing on R&D and registration for international markets. To date, the company has obtained 2 European formulation approvals, 3 U.S. formulation approvals, 16 formulation approvals in emerging markets, 8 Certificates of Suitability to the European Pharmacopoeia (CEP certificates), submitted over 30 DMFs (Drug Master Files) in China, the U.S., Europe, and Japan, as well as more than 50 other DMFs in emerging markets. Currently under review are 7 U.S. ANDAs, 2 European MAs (Marketing Authorizations), and 10 Chinese formulation products.
Proofread by Lu Qian