In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a CZ0012 Drug Master File in Korea (CZ0012 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CZ0012. The MFDS reviews the CZ0012 KDMF as part of the drug registration process and uses the information provided in the CZ0012 KDMF to evaluate the safety and efficacy of the drug.
After submitting a CZ0012 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 CZ0012 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of CZ0012 suppliers with KDMF on PharmaCompass.