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