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