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