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