In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a NitroMist Drug Master File in Korea (NitroMist KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of NitroMist. The MFDS reviews the NitroMist KDMF as part of the drug registration process and uses the information provided in the NitroMist KDMF to evaluate the safety and efficacy of the drug.
After submitting a NitroMist 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 NitroMist API can apply through the Korea Drug Master File (KDMF).
click here to find a list of NitroMist suppliers with KDMF on PharmaCompass.