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