DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)8.1 LIST OF PROHIBITED AND RESTRICTED ACTIVE INGREDIENTS ANDCOMBINATION8.1.1 LIST OF PROHIBITED ACTIVE INGREDIENTS AND COMBINATIONSa) Prohibited Active IngredientsNO.PROHIBITED ACTIVE INGREDIENTS1. 1,3-dimethylamylamine (DMAA)2. Aristolochic Acid3. Aminopyrine/ Amidopyrine4. Astemizole5. Bacillus Coagulans6. Berberine7. Butobarbitone8. Chlormezanone9. Cisapride10. Conjugated Linoleic Acid11. Crinis Carbonisatus12. Danthron13. Dipyrone14. Enterococcus Faecalis15. Enterococcus Faecium16. Ethenzamide17. Euflavine18. Furazolidone19. Fenfluramine/ Dexfenfluramine20. Gentian Violet21. Gamma-Butyrolactone (GBL)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 330
Drug Registration Guidance Document (<strong>DRGD</strong>)22. Gamma-Hydroxybutyric Acid (GHB)23. Haloquinol24. Hexachlorophene25. Mercurochrome26. Nimesulide27. Novobiocin28. Oxyphenisatin Acetate/ Acetophenolisatin29. Oxyphenbutazone30. Pergolide31. Phenacetin32. Phenazone/ Antipyrine- Propylphenazone- Isopropylphenazone33. Phenylbutazone34. Phenylpropalamine35. Piperazine36. Prenylamine37. Quinalbarbitone38. Salicylamide39. Sibutramine40. Stanozolol41. Sulphaguanide42. Thioridazine43. Tegaserod44. TerfenadineNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 331
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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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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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