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