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