FDA Guidance for Industry: Drug Master Files for Bulk Antibiotic Drug Substances

https://www.gmp-navigator.com/files/guidemgr/3276fnl.pdf

Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/cder/guidance , http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070557.pdf