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