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