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