In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Duralta-12 Drug Master File in Korea (Duralta-12 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Duralta-12. The MFDS reviews the Duralta-12 KDMF as part of the drug registration process and uses the information provided in the Duralta-12 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Duralta-12 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 Duralta-12 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Duralta-12 suppliers with KDMF on PharmaCompass.