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