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