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