Galantamine Hydrobromide

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ACTIVE PHARMA INGREDIENTS

31 API Suppliers, 15 USDMF, 8 CEP/COS, 3 JDMF, 1 EU WC, 5 KDMF, 7 NDC API, 14 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

9 Drugs in Development

9 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

218 FDF Dossiers, 71 FDA Orange Book, 80 Europe, 15 Canada, 24 Australia, 9 South Africa, 19 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TABLET;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Rochem International Inc, 18 SPI Pharma, 11 DKSH, 5 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 2 Kirsch Pharma, 4 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 30 BASF, 1 Clariant, 11 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 11 Gangwal Chemicals, 4 Ideal Cures, 4 Ingredion Pharma Solutions, 24 Kerry, 2 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 5 Pharmatrans-Sanaq, 6 Pluviaendo, 3 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, 10 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Vertellus

EXCIPIENTS BY APPLICATIONS

73 Fillers, Diluents & Binders, 48 Coating Systems & Additives, 42 Direct Compression, 35 Disintegrants & Superdisintegrants, 35 Granulation, 33 Thickeners and Stabilizers, 27 Controlled & Modified Release, 26 Solubilizers, 24 Taste Masking, 21 Chewable & Orodispersible Aids, 21 Lubricants & Glidants, 17 Film Formers & Plasticizers, 16 Parenteral, 16 Topical, 13 Co-Processed Excipients, 9 Empty Capsules, 8 Emulsifying Agents, 6 Surfactant & Foaming Agents, 6 Rheology Modifiers, 5 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 8 News #PharmaBuzz

GLOBAL SALES INFORMATION

10 US Medicaid Prescriptions, 45 Regulatory FDF Prices, 6 Annual Reports

MARKET PLACE

8 APIs

8 APIs

PATENTS & EXCLUSIVITIES

20 Health Canada Patents

20 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 5 Others

$ Xls

Filters

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USFDA APPLICATION NUMBER - 21615 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 24MG 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	24mg \| 16mg \| 8mg

Inactive Ingredients

Ingredient Name	Janssen Pharmaceuticals, Inc.	Patriot Pharmaceuticals, LLC
aluminum oxide(LMI26O6933)
CROSPOVIDONE (120 .MU.M)(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)
lactose monohydrate(EWQ57Q8I5X)
magnesium stearate(70097M6I30)
microcrystalline cellulose(OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
silicon dioxide(ETJ7Z6XBU4)
talc(7SEV7J4R1U)
titanium dioxide(15FIX9V2JP)

Setid 3bea9961 4d8a 4cf3 8b63 49af2b1fbb5b Applno 21615 Form Capsule Extended Release Oral Dosage Eq 24mg Base - Drug Product Composition: Galantamine Hydrobromide