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