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