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 and simethicone Drug Master File in Korea (Loperamide hydrochloride and simethicone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Loperamide hydrochloride and simethicone. The MFDS reviews the Loperamide hydrochloride and simethicone KDMF as part of the drug registration process and uses the information provided in the Loperamide hydrochloride and simethicone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Loperamide hydrochloride and 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 and simethicone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Loperamide hydrochloride and simethicone suppliers with KDMF on PharmaCompass.