In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a KS-1200 Drug Master File in Korea (KS-1200 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of KS-1200. The MFDS reviews the KS-1200 KDMF as part of the drug registration process and uses the information provided in the KS-1200 KDMF to evaluate the safety and efficacy of the drug.
After submitting a KS-1200 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 KS-1200 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of KS-1200 suppliers with KDMF on PharmaCompass.