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