Aliskiren

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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EQ 300MG BASE, TABLET;ORAL - EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE, TABLET;ORAL - EQ 300MG BASE, TABLET;ORAL - EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 - 22107 / DOSAGE - TABLET;ORAL - EQ 150MG BASE;12.5MG **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
ALISKIREN HEMIFUMARATE(UNII: C8A0P8G029) (ALISKIREN - UNII:502FWN4Q32)	ALISKIREN	300mg \| 300mg \| 150mg \| 150mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	25mg \| 12.5mg \| 25mg \| 12.5mg

Inactive Ingredients

Ingredient Name	Novartis Pharmaceuticals Corporation
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSPOVIDONE(68401960MK)
FERRIC OXIDE RED(1K09F3G675)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POVIDONE(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
STARCH, WHEAT(79QS2MG2LP)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Aliskiren

Aliskiren

Aliskiren

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

8 API Suppliers

4 USDMF

3 EU WC

3 NDC API

4 Listed Suppliers

INTERMEDIATES

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

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;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