In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a CPP-109 Drug Master File in Korea (CPP-109 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CPP-109. The MFDS reviews the CPP-109 KDMF as part of the drug registration process and uses the information provided in the CPP-109 KDMF to evaluate the safety and efficacy of the drug.
After submitting a CPP-109 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 CPP-109 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of CPP-109 suppliers with KDMF on PharmaCompass.