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