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