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