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