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