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