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