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