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