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