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