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