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