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