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