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