DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Botanical Name*Common or Other NamesTropicosdoes not list this species as a synonym for anyThotteaspecies. Kew Gardens Herbarium does notrecognize thegenera Bragantia. Until additional information isobtained wewill use the name as cited in J. Nat. Products45:657-666(1982)List B: Botanicals which may be Adulterated with Aristolochic AcidTable 4:Botanical Name*Common or Other NamesAkebia spp.Akebia quinata (Houtt.) Decne.Syn. Rajania quinata Houtt.AkebiaMu tongKu mu tongZi mutongBai mu tongMokutsu (Japanese)Mokt'ong (KoreanChocolate vineFiveleaf akebiaMu tongYu zhi ziMokutsu (Japanese)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 254
Drug Registration Guidance Document (<strong>DRGD</strong>)Botanical Name*Akebia trifoliata (Thunb.) Koidz.Asarum forbesii Maxim.Asarum heterotropoides F. SchmidtSyn. Asarum heterotropoides F. SchmidtSyn. Asiasarum heterotropoides (F. Schmidt) F.Maek.Asarum sieboldii Miq.Syn. Asarum sieboldii fo. seoulense (Nakai) C.Y.Cheng &C.S. YangSyn. Asarum sieboldii var. seoulensis NakaiSyn. Asiasarum heterotropoides var. seoulense(Nakai) F.Maek.Syn. Asiasarum sieboldii (Miq.) F. Maek.Clematis spp.Common or Other NamesMu tongThree leaf akebiaYu zhi ziBatei-saishin(Japanese)Keirin-saishin(Japanese)Chinese wild gingerManchurian wildgingerBei xi xinXin xinUsuba-saishin(Japanese)Chinese wild gingerXi XinHua Xi XinManchurian wildgingerSiebold's wild gingerClematisMufangjiClematidisIreisen (Japanese)Wojoksum (Korean)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 255
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Page 204 and 205: Drug Registration Guidance Document
Page 230 and 231: PART III: NON-CLINICAL DATADrug Reg
Page 232 and 233: - All information must be provided
Page 242 and 243: 1.2 EXEMPTION FROM PRODUCT REGISTRA
Page 292 and 293: For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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