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