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