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