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