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