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