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