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