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