In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a KMB 100-200 Drug Master File in Korea (KMB 100-200 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of KMB 100-200. The MFDS reviews the KMB 100-200 KDMF as part of the drug registration process and uses the information provided in the KMB 100-200 KDMF to evaluate the safety and efficacy of the drug.
After submitting a KMB 100-200 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 KMB 100-200 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of KMB 100-200 suppliers with KDMF on PharmaCompass.