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