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