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