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