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