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