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