ALISKIREN HEMIFUMARATE

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

8 API Suppliers, 4 USDMF, 3 EU WC, 3 NDC API, 4 Listed Suppliers

INTERMEDIATES

5 Intermediates Suppliers

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

24 FDF Dossiers, 20 FDA Orange Book, 4 Europe

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 150MG BASE, TABLET;ORAL - EQ 300MG BASE, TABLET;ORAL - EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE, TABLET;ORAL - EQ 300MG BASE, TABLET;ORAL - EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 2 Seqens, 4 DKSH, 2 Faran Shimi Pharmaceutical, 5 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 1 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 22 BASF, 10 Corel Pharma Chem, 2 DFE Pharma, 1 Finar, 8 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 16 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 2 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 10 Roquette, 6 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

44 Coating Systems & Additives, 33 Fillers, Diluents & Binders, 28 Controlled & Modified Release, 24 Direct Compression, 19 Thickeners and Stabilizers, 18 Disintegrants & Superdisintegrants, 17 Granulation, 13 Solubilizers, 13 Lubricants & Glidants, 11 Co-Processed Excipients, 8 Film Formers & Plasticizers, 7 Topical, 6 Chewable & Orodispersible Aids, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Taste Masking, 4 Emulsifying Agents, 4 Parenteral, 2 Rheology Modifiers

DIGITAL CONTENT

13 NEWS #PharmaBuzz

13 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 4 Finished Drug Prices, 1 Annual Reports

MARKET PLACE

1 APIs, 1 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 2 Health Canada Patents

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USFDA APPLICATION NUMBER - 21985 / DOSAGE - TABLET;ORAL - EQ 300MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALISKIREN HEMIFUMARATE(UNII: C8A0P8G029) (ALISKIREN - UNII:502FWN4Q32)	ALISKIREN	300mg \| 150mg

Inactive Ingredients

Ingredient Name	A-S Medication Solutions	Avera McKennan Hospital	Novartis Pharmaceuticals Corporation
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
CROSPOVIDONE(2S7830E561)
CROSPOVIDONE(68401960MK)
FERRIC OXIDE RED(1K09F3G675)
FERROSOFERRIC OXIDE(XM0M87F357)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
SILICON DIOXIDE(ETJ7Z6XBU4)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: ALISKIREN HEMIFUMARATE