In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Benox 50 Drug Master File in Korea (Benox 50 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Benox 50. The MFDS reviews the Benox 50 KDMF as part of the drug registration process and uses the information provided in the Benox 50 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Benox 50 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 Benox 50 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Benox 50 suppliers with KDMF on PharmaCompass.