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