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