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