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