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