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