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