DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Part of plantprohibitedGenusSpeciesCommon/Local Name(whole plantunlessotherwisespecified)Constituent(s) ofconcernPapaver somniferum Opium poppyMorphine,codeine,hydrocodone,meperidine,methadone,papaverineYohimbe,JohimbePausinystaliayohimbeSyn.Corynanthejohimbi,Corynanthe yohimbiYohimbinePhysostigma venenosum Calabar bean PhysostigminePilocarpusmicrophyllusPilocarpusjaborandi,jaborandiPilocarpinePunica granatum Pomegranate Bark Iso-PellatrierineRauwolfiaserpentinaIndiansnakeroot,SerpentinerootReserpineRauwolfiavomitoriaAfricanserpentwoodReserpineSchoenocaulonofficinaleVeratrumofficinaleSabadilla,VeratrineScillaebulbusSea onion,SquillSolanumnigrumBlacknightshadeSolanineNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 246
Drug Registration Guidance Document (<strong>DRGD</strong>)Part of plantprohibitedGenusSpeciesCommon/Local Name(whole plantunlessotherwisespecified)Constituent(s) ofconcernStrychnosnux-vomicaPoison nut,Quaker button,strychninetree, ma qianzi/maqianziStrychnineValerianAll speciesAll partsexcept forroot partValepotriatesVeratrumAll speciesVincaAll speciesIncludingCatharanthusroseusVinca, Vincristine,Vinblastine,VinpocetinNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 247
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Page 196 and 197: Drug Registration Guidance Document
Page 202 and 203: Appearance/organoleptic(odor, color
Page 220 and 221: ATTACHMENT 1Drug Registration Guida
Page 228 and 229: PART IV: CLINICAL DOCUMENTSDrug Reg
Page 230 and 231: ATTACHMENT 2Drug Registration Guida
Page 236 and 237: APPENDIX 5:Drug Registration Guidan
Page 238 and 239: 1. GENERAL INFORMATIONSDrug Registr
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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