In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a AC-1640 Drug Master File in Korea (AC-1640 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of AC-1640. The MFDS reviews the AC-1640 KDMF as part of the drug registration process and uses the information provided in the AC-1640 KDMF to evaluate the safety and efficacy of the drug.
After submitting a AC-1640 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 AC-1640 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of AC-1640 suppliers with KDMF on PharmaCompass.