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          ANDAs: Impurities in Drug SubstancesSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	ANDAs: Impurities in Drug Substances
					Guidance for Industry
		
		July 2009


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
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    PrintDocket Number:
		    FDA-1998-D-0021
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


This guidance provides revised recommendations on what chemistry, manufacturing, and controls (CMC) information to include regarding the reporting, identification, and qualification of impurities in drug substances produced by chemical synthesis when submitting


 
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                                                                                  Content current as of:
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