New Media Department              Yu Jie, Duan Yuqing                February 9, 2023

On February 7, Lunan Pharma Shandong New Time Pharmaceutical Co., Ltd. received the FIRST ADEQUATE letter of milrinone API (DMF 035346) issued by the US FDA. According to FDA's review process for APIs, the issuance of this letter means that Milrinone APIs have passed the technical review.

Milrinone API has been approved for marketing in the United States, indicating that the quality and quality assurance system of the API has been fully recognized by the regulatory market and can meet the requirements of global customers for US FDA preparation declaration.

In order to speed up the process of internationalization, Lunan Pharma established an international drug research and development center to focus on research and development and declaration in the global market. At present, Lunan Pharma has obtained 2 approvals for preparations in Europe, 3 approvals for preparations in the United States, 18 approvals for preparations in emerging markets, 8 CEP certificates, and submitted more than 30 DMFs in China, the United States, Europe and Japan, and more than 50 DMFs in other emerging markets ; 7 US ANDAs, 2 European MAs and 10 Chinese formulations are under review. As more products are developed and launched, it will definitely speed up the company's pace of entering the international market, enhance the brand image and popularity of Lunan Pharma at home and abroad, and lay the foundation for the prospect of "keeping the world healthy".

If necessary, please contact the below business information of Lunan Pharmaceutical (+86-539-8331258, 8336118).