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