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