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