In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a AGN-1255 Drug Master File in Korea (AGN-1255 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of AGN-1255. The MFDS reviews the AGN-1255 KDMF as part of the drug registration process and uses the information provided in the AGN-1255 KDMF to evaluate the safety and efficacy of the drug.
After submitting a AGN-1255 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 AGN-1255 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of AGN-1255 suppliers with KDMF on PharmaCompass.