In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Natispray Drug Master File in Korea (Natispray KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Natispray. The MFDS reviews the Natispray KDMF as part of the drug registration process and uses the information provided in the Natispray KDMF to evaluate the safety and efficacy of the drug.
After submitting a Natispray KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Natispray API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Natispray suppliers with KDMF on PharmaCompass.