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