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