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 ANDCOMBINATIONSa) Prohibited Active IngredientsNO.PROHIBITED ACTIVE INGREDIENTS1. Aristolochic Acid2. Aminopyrine/ Amidopyrine3. Astemizole4. Bacillus Coagulans5. Berberine6. Butobarbitone7. Chlormezanone8. Cisapride9. Conjugated Linoleic Acid10. Crinis Carbonisatus11. Danthron12. Dipyrone13. Enterococcus Faecalis14. Enterococcus Faecium15. Ethenzamide16. Euflavine17. Furazolidone18. Fenfluramine/ Dexfenfluramine19. Gentian Violet20. Gamma-Butyrolactone (GBL)21. Gamma-Hydroxybutyric Acid (GHB)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 324
Drug Registration Guidance Document (<strong>DRGD</strong>)22. Haloquinol23. Hexachlorophene24. Mercurochrome25. Nimesulide26. Novobiocin27. Oxyphenisatin Acetate/ Acetophenolisatin28. Oxyphenbutazone29. Pergolide30. Phenacetin31. Phenazone/ Antipyrine- Propylphenazone- Isopropylphenazone32. Phenylbutazone33. Phenylpropalamine34. Piperazine35. Prenylamine36. Quinalbarbitone37. Salicylamide38. Sibutramine39. Stanozolol40. Sulphaguanide41. Thioridazine42. Tegaserod43. TerfenadineNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 325
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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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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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