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