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