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