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