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