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