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