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