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