In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Calcilit 100 Drug Master File in Korea (Calcilit 100 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Calcilit 100. The MFDS reviews the Calcilit 100 KDMF as part of the drug registration process and uses the information provided in the Calcilit 100 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Calcilit 100 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 Calcilit 100 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Calcilit 100 suppliers with KDMF on PharmaCompass.