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