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