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