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