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