In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a LUPEROX(R) A75FP Drug Master File in Korea (LUPEROX(R) A75FP KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of LUPEROX(R) A75FP. The MFDS reviews the LUPEROX(R) A75FP KDMF as part of the drug registration process and uses the information provided in the LUPEROX(R) A75FP KDMF to evaluate the safety and efficacy of the drug.
After submitting a LUPEROX(R) A75FP 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 LUPEROX(R) A75FP API can apply through the Korea Drug Master File (KDMF).
click here to find a list of LUPEROX(R) A75FP suppliers with KDMF on PharmaCompass.