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