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