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