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