In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a (6S)-5-Formyl-5,6,7,8-tetrahydrofolic acid Drug Master File in Korea ((6S)-5-Formyl-5,6,7,8-tetrahydrofolic acid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of (6S)-5-Formyl-5,6,7,8-tetrahydrofolic acid. The MFDS reviews the (6S)-5-Formyl-5,6,7,8-tetrahydrofolic acid KDMF as part of the drug registration process and uses the information provided in the (6S)-5-Formyl-5,6,7,8-tetrahydrofolic acid KDMF to evaluate the safety and efficacy of the drug.
After submitting a (6S)-5-Formyl-5,6,7,8-tetrahydrofolic 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 (6S)-5-Formyl-5,6,7,8-tetrahydrofolic acid API can apply through the Korea Drug Master File (KDMF).
click here to find a list of (6S)-5-Formyl-5,6,7,8-tetrahydrofolic acid suppliers with KDMF on PharmaCompass.