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