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Pipeline Prospector Feb 2025: Bain buys Mitsubishi Tanabe for US$ 3.4 bn; Japan’s Ono gets FDA nod for rare joint tumor drug

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Aliskiren

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ACTIVE PHARMA INGREDIENTS

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

INTERMEDIATES

5 Intermediate Suppliers

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300MG BASE, TABLET;ORAL - EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 6 DKSH, 2 Faran Shimi Pharmaceutical, 5 Boai NKY Pharmaceuticals Ltd, 2 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, 30 Fillers, Diluents & Binders, 27 Controlled & Modified Release, 20 Thickeners and Stabilizers, 18 Direct Compression, 17 Disintegrants & Superdisintegrants, 17 Granulation, 13 Solubilizers, 12 Lubricants & Glidants, 8 Film Formers & Plasticizers, 7 Topical, 7 Co-Processed Excipients, 6 Chewable & Orodispersible Aids, 5 Empty Capsules, 5 Coloring Agents, 4 Emulsifying Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Taste Masking, 2 Parenteral

DIGITAL CONTENT

13 News #PharmaBuzz

13 News #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 4 Regulatory FDF Prices, 1 Annual Reports

MARKET PLACE

1 APIs, 1 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 2 Health Canada Patents

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Product Main Page

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/03/2025	Changzhou Pharmaceutical Factory	China	CHANGZHOU PHARMACEUTICAL FACTORY	24755	ALISKIREN HEMIFUMARATE	2011-03-10	Inactive	II	N/A
28/03/2025	CHEMO IBERICA SA	Spain	CHEMO IBERICA SA	26776	ALISKIREN HEMIFUMARATE	2012-12-27	Inactive	II	N/A

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 Intermediate 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**

RELATED EXCIPIENT COMPANIES

1 SPI Pharma

6 DKSH

2 Faran Shimi Pharmaceutical

5 Boai NKY Pharmaceuticals Ltd

2 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

30 Fillers, Diluents & Binders

27 Controlled & Modified Release

20 Thickeners and Stabilizers

18 Direct Compression

17 Disintegrants & Superdisintegrants

17 Granulation

13 Solubilizers

12 Lubricants & Glidants

8 Film Formers & Plasticizers

7 Topical

7 Co-Processed Excipients

6 Chewable & Orodispersible Aids

5 Empty Capsules

5 Coloring Agents

4 Emulsifying Agents

4 Rheology Modifiers

4 Vegetarian Capsules

4 API Stability Enhancers

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