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