Lunan Pharmaceutical’s Ningte® isoflurane for inhalation receives marketing approval in Sri Lanka.

June 4, 2026  Source: drugdu 29

"/Recently , Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group, received a drug registration certificate for Ningte® isoflurane inhalation issued by the National Medicines Agency ( NMRA ) of Sri Lanka . This signifies that the product can be exported to Sri Lanka for commercial sale. Obtaining this approval is an international recognition of the completeness and compliance of the company's quality system, technical standards, and registration documents.

Inhaled isoflurane is suitable for the induction and maintenance of general anesthesia . With its advantages of rapid induction, rapid recovery, and low metabolic rate, it is widely used in various surgeries. Currently, this product is available in China, the United States, and Japan, and registration applications have been submitted in several countries, including Tanzania and Pakistan . The company is accelerating its global supply expansion to provide patients with a safe and effective anesthetic option.

During the registration process in Sri Lanka, the R&D team strictly adhered to local regulations, efficiently prepared technical documentation and communicated with reviewers, steadily advancing the listing application and securing successful approval. This achievement not only enhances the company's product portfolio in emerging markets such as South Asia but also lays a solid foundation for future market access and commercialization cooperation.

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 33 formulation approvals in China, the US, and Europe, 68 formulation approvals in emerging markets , 8 CEP certificates , and 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 center will undoubtedly accelerate the company's pace in entering the international market, enhance Lunan Pharmaceutical's brand image and reputation both domestically and internationally, and inject strong momentum into " Lunan Pharmaceutical's vision of a healthy world . "

https://bydrug.pharmcube.com/news/detail/b947fa7e1b621b8fc53b0ae1f16840eb

By editor
Share: 

your submission has already been received.

OK

Subscribe

Please enter a valid Email address!

Submit

The most relevant industry news & insight will be sent to you every two weeks.