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