Lunan Pharmaceutical Ningte® Isoflurane for Inhalation Obtains Marketing Approval in Tanzania
Recently, Lunan Pharmaceutical Group Shandong New Time Pharmaceutical received the drug registration certificate for Nint® Isoflurane for Inhalation (Registration Number: TAN 26 HM 0098) issued by the Tanzania Medicines and Medical Devices Authority (TMDA), marking that the product has officially obtained market access qualifications in Tanzania and can be sold and commercialized locally.
Isoflurane for inhalation is suitable for the induction and maintenance of general anesthesia. It is widely used in various surgeries due to its advantages of fast induction, rapid recovery, and low metabolic rate. Currently, this product has been launched in China, the United States, Japan and other countries, and marketing applications have been submitted in many countries such as Ethiopia and Pakistan. It is accelerating the global supply layout and providing patients with safe and effective anesthetic drug choices.
During the product marketing application process, the registration team strictly followed TMDA requirements and efficiently completed document preparation and reissue response. Shandong New Time Pharmaceutical successfully passed the TMDA on-site GMP inspection, ensuring the successful approval of the product. This approval not only enriches the company's product layout in the African market, but also lays a solid foundation for subsequent development of markets in East Africa and surrounding countries.
The International Drug Research and Development Center was established in 2017 as a window for Lunan Pharmaceutical Group to move towards internationalization. It adheres to the internationalization strategy of "based on domestic and radiating globally". It has currently obtained 33 preparation approvals from China, the United States and Europe, 70 preparation approvals from emerging markets, 8 CEP certificates, and submitted more than 40 DMFs from Europe, the United States and Japan, and more than 50 DMFs from other emerging markets. As more products are developed and launched on the market, it will surely accelerate the company's entry into the international market, enhance the brand image and popularity of Lunan Pharmaceutical at home and abroad, and lay the foundation for "Lunan Pharmaceutical Healthy World".