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