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