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