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