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