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