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