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