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