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