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