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