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