In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a CEP-10953 Drug Master File in Korea (CEP-10953 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CEP-10953. The MFDS reviews the CEP-10953 KDMF as part of the drug registration process and uses the information provided in the CEP-10953 KDMF to evaluate the safety and efficacy of the drug.
After submitting a CEP-10953 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 CEP-10953 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of CEP-10953 suppliers with KDMF on PharmaCompass.