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