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