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