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