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