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