Galantamine Hydrobromide

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ACTIVE PHARMA INGREDIENTS

29 API Suppliers, 15 USDMF, 8 CEP/COS, 4 JDMF, 2 EU WC, 5 KDMF, 7 NDC API, 15 Listed Suppliers, $ API Reference Price

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2 Drugs in Development

INTERMEDIATES

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1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

246 FDF Dossiers, 71 FDA Orange Book, 110 Europe, 15 Canada, 24 Australia, 9 South Africa, 17 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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1 Minakem, 2 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 9 DKSH, 2 Jai Radhe Sales, 6 Faran Shimi Pharmaceutical, 5 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 13 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 30 BASF, 1 Clariant, 11 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 37 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 5 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 19 Roquette, 14 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Vertellus

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PATENTS & EXCLUSIVITIES

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REF. STANDARDS & IMPURITIES

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USFDA APPLICATION NUMBER - 21169 / DOSAGE - TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
galantamine hydrobromide(UNII: MJ4PTD2VVW) (galantamine - UNII:0D3Q044KCA)	galantamine	12mg

Inactive Ingredients

Ingredient Name	Avera McKennan Hospital	Janssen Pharmaceuticals, Inc.
aluminum oxide(LMI26O6933)
cellulose, microcrystalline(OP1R32D61U)
CROSPOVIDONE (120 .MU.M)(68401960MK)
crospovidone (15 mpa.s at 5%)(68401960MK)
crospovidone(68401960MK)
D&C Yellow No. 10(35SW5USQ3G)
diethyl phthalate(UF064M00AF)
ethylcellulose, unspecified(7Z8S9VYZ4B)
ferric oxide red(1K09F3G675)
ferric oxide yellow(EX438O2MRT)
gelatin, unspecified(2G86QN327L)
hypromellose, unspecified(3NXW29V3WO)
hypromelloses(3NXW29V3WO)
lactose monohydrate(EWQ57Q8I5X)
magnesium stearate(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
polyethylene glycol, unspecified(3WJQ0SDW1A)
silicon dioxide(ETJ7Z6XBU4)
talc(7SEV7J4R1U)
titanium dioxide(15FIX9V2JP)

Drug Product Composition: Galantamine Hydrobromide