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