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