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