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