In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a AH 2250 Drug Master File in Korea (AH 2250 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of AH 2250. The MFDS reviews the AH 2250 KDMF as part of the drug registration process and uses the information provided in the AH 2250 KDMF to evaluate the safety and efficacy of the drug.
After submitting a AH 2250 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 AH 2250 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of AH 2250 suppliers with KDMF on PharmaCompass.