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Aliskiren
FDA Orange Book

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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xyz-pharma-m-2024-10-07

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With Fermion, start the journey of your innovative API.

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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xyz-pharma-m-2024-10-07

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Aliskiren

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

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

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

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300MG BASE, TABLET;ORAL - EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE, TABLET;ORAL - EQ 300MG BASE, TABLET;ORAL - EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for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

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

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

3 US Medicaid Prescriptions
4 Finished Drug Prices
1 Annual Reports

MARKET PLACE

1 APIs, 1 FDF Dossiers

1 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 2 Health Canada Patents

14 US Patents
2 Health Canada Patents

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filter Applicant Reset all filters

20 All

01 2ENDO OPERATIONS

02 7NODEN PHARMA

03 11NOVARTIS

filter Dosage Reset all filters

20 All

01 1CAPSULE, PELLET;ORAL

02 19TABLET;ORAL

filter Regulatory Info Reset all filters

20 All

01 16DISCN

02 4RX

filter Brand Name Reset all filters

20 All

01 2ALISKIREN HEMIFUMARATE

02 5AMTURNIDE

03 4TEKAMLO

04 3TEKTURNA

05 4TEKTURNA HCT

06 2VALTURNA

filter RLD Reset all filters

20 All

01 13No

02 7Yes

List of Suppliers

Product Main Page

01

NODEN PHARMA

Antibody Engineering

Not Confirmed

NODEN PHARMA

Antibody Engineering

Not Confirmed

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RLD : Yes

TE Code : AB

ALISKIREN HEMIFUMARATE

Brand Name : TEKTURNA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date : 2007-03-05

Application Number : 21985

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

NODEN PHARMA

Antibody Engineering

Not Confirmed

NODEN PHARMA

Antibody Engineering

Not Confirmed

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RLD : Yes

TE Code : AB

ALISKIREN HEMIFUMARATE

Brand Name : TEKTURNA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 300MG BASE

Approval Date : 2007-03-05

Application Number : 21985

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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Digital Content

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03

NODEN PHARMA

Antibody Engineering

Not Confirmed

NODEN PHARMA

Antibody Engineering

Not Confirmed

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RLD : Yes

TE Code :

ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE

Brand Name : TEKTURNA HCT

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2008-01-18

Application Number : 22107

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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04

NODEN PHARMA

Antibody Engineering

Not Confirmed

NODEN PHARMA

Antibody Engineering

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RLD : Yes

TE Code :

ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE

Brand Name : TEKTURNA HCT

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2008-01-18

Application Number : 22107

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

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05

NODEN PHARMA

Antibody Engineering

Not Confirmed

NODEN PHARMA

Antibody Engineering

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE

Brand Name : TEKTURNA HCT

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2008-01-18

Application Number : 22107

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

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06

NODEN PHARMA

Antibody Engineering

Not Confirmed

NODEN PHARMA

Antibody Engineering

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE

Brand Name : TEKTURNA HCT

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2008-01-18

Application Number : 22107

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

NOVARTIS

Antibody Engineering

Not Confirmed

NOVARTIS

Antibody Engineering

Not Confirmed

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RLD : No

TE Code :

ALISKIREN HEMIFUMARATE; VALSARTAN

Brand Name : VALTURNA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE;160MG

Approval Date : 2009-09-16

Application Number : 22217

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

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08

NOVARTIS

Antibody Engineering

Not Confirmed

NOVARTIS

Antibody Engineering

Not Confirmed

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Digital Content

RLD : No

TE Code :

ALISKIREN HEMIFUMARATE; VALSARTAN

Brand Name : VALTURNA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 300MG BASE;320MG

Approval Date : 2009-09-16

Application Number : 22217

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

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09

NOVARTIS

Antibody Engineering

Not Confirmed

NOVARTIS

Antibody Engineering

Not Confirmed

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Digital Content

RLD : No

TE Code :

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

Brand Name : TEKAMLO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE;EQ 5MG BASE

Approval Date : 2010-08-26

Application Number : 22545

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

NOVARTIS

Antibody Engineering

Not Confirmed

NOVARTIS

Antibody Engineering

Not Confirmed

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Digital Content

RLD : No

TE Code :

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

Brand Name : TEKAMLO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE;EQ 10MG BASE

Approval Date : 2010-08-26

Application Number : 22545

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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