In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a [5, 6-3H]-niacin Drug Master File in Korea ([5, 6-3H]-niacin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of [5, 6-3H]-niacin. The MFDS reviews the [5, 6-3H]-niacin KDMF as part of the drug registration process and uses the information provided in the [5, 6-3H]-niacin KDMF to evaluate the safety and efficacy of the drug.
After submitting a [5, 6-3H]-niacin 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 [5, 6-3H]-niacin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of [5, 6-3H]-niacin suppliers with KDMF on PharmaCompass.