In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a K-115 (ripasudil hydrochloride dihydrate) Drug Master File in Korea (K-115 (ripasudil hydrochloride dihydrate) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of K-115 (ripasudil hydrochloride dihydrate). The MFDS reviews the K-115 (ripasudil hydrochloride dihydrate) KDMF as part of the drug registration process and uses the information provided in the K-115 (ripasudil hydrochloride dihydrate) KDMF to evaluate the safety and efficacy of the drug.
After submitting a K-115 (ripasudil hydrochloride dihydrate) 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 K-115 (ripasudil hydrochloride dihydrate) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of K-115 (ripasudil hydrochloride dihydrate) suppliers with KDMF on PharmaCompass.