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