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