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