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