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