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