In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a ETRAFON 2-25 Drug Master File in Korea (ETRAFON 2-25 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ETRAFON 2-25. The MFDS reviews the ETRAFON 2-25 KDMF as part of the drug registration process and uses the information provided in the ETRAFON 2-25 KDMF to evaluate the safety and efficacy of the drug.
After submitting a ETRAFON 2-25 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 ETRAFON 2-25 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ETRAFON 2-25 suppliers with KDMF on PharmaCompass.