DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)NO.COLOURING AGENTSCOLOURINDEXNUMBER (CI)25. Indigo Carmine/ FD & C Blue No. 2 7301526. Brilliant Blue FCF Ammonium Salt/ D & C Blue No. 4 4209027. Alizarin Cyanine Green F/ D & C Green No. 5 6157028. Toney Red/ D & C Red No. 17 2610029. Eosin YS Acid Form/ D & C Red No. 21 45380:230. Eosinys Sodium Salt/ D & C Red No. 22 4538031. Phloxine B Acid Form/ D & C Red No. 27 45410:132. Phloxine B Sodium Salt/ D & C Red No. 28 4541033. Helindone Pink CN/ D & C Red No. 30 7336034. Erythrosine/FD & C Red No. 3 4543035. Yellow 2G (Food Yellow)37.Orange Yellow S Sunset Yellow FCF(FD & C Yellow No. 6, E110)15985National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 340
Drug Registration Guidance Document (<strong>DRGD</strong>)8.3.2 List of Restricted Colouring AgentsThe following colouring agents are ALLOWED in preparations as stated in theparentheses:NO.1.2.3.4.5.6.7.8.9.10.11.12.13.14.15.COLOURING AGENTSDihydroxyacetone(external use with specific drugs only)Bismuth Oxychloride(external use only, including eye)Ferric Ammonium Ferrocyanide(external use only, including eye)Ferric Ferrocyanide(external eye only)Chromium Hydroxide Green(external use only)Chromium Oxide Green(external use only, including eye)Guanine(external use only)Prophyllite(external use only)Mica(external use only, including eye)Bronze(external use only, including eye)Copper(external use only, including eye)Zinc Oxide(external use only, including eye)Quinizarine Green SS/ D & C Green No. 6(external use only)Pyranine Concentrated/ D & C Green No. 8(external use only)Orange II/ D & C Orange No. 4(external use only)COLOURINDEXNUMBER (CI)7716377289751707701977947615655904015510National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 341
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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