DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)NO.SUBSTANCES22. BROMAZEPAM23. BROMOCRIPTINE24. BROMPHENIRAMINE25. CAMPHOR26. CARBAMAZEPINE27. CARBIMAZOLE28. CABERGOLINE29. CEFTRIAXONE30. CETIRIZINE31. CHELIDONIUM MAJUS32. CHITOSAN33. CHLORPHENIRAMINE34. CHORIONIC GONADOTROPHIN35. CLEMASTINE36. CLINDAMYCIN37. CLOBAZAM38. CLOPIDOGREL39. CLOZAPINE40. COLCHICINE41. COX-2 INHIBITORS42. CYPROTERONE ACETATE43. CYTOTOXIC AGENT44. DEXBROMPHENIRAMINE45. DEXTROMETHORPHAN46. DIAZEPAMNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 354
Drug Registration Guidance Document (<strong>DRGD</strong>)NO.SUBSTANCES47. DICLOFENAC SODIUM48. DICYCLOMINE49. DIPHENHYDRAMINE50. DIPHENOXYLATE51. DOPAMINERGIC INGREDIENT52. EPHEDRINE53. FAMOTIDINE54. FIBRATES55. FLUCLOXACILLIN56. FLUORIDE57. FLUOROQUINOLONES58. FLURAZEPAM HYDROCHLORIDE59. GADOBENIC ACID60. GADOBUTROL61. GADODIAMIDE62. GADOLINIUM OXIDE63. GADOTERIC ACID64. GADOVERSETAMIDE65. GADOXETIC ACID66.GADOLINIUM BASED CONTRAST MEDIUM FOR MAGNETICRESONANCE IMAGING67. GENTAMICIN TOPICAL PREPARATIONS68. GINKGO BILOBA/ GINKGO EXTRACT69. GINSENG70. GLUCOSAMINE71. HIV PROTEASE INHIBITORSNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 355
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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Page 304 and 305: Drug Registration Guidance Document
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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