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