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