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