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