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