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