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