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