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