Azilsartan | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Azilsartan
FDA Orange Book

munit-sa-m-2025-04-14

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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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SPI Pharma has been solving formulation challenges using superior functional materials.

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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Suanfarma, at the Core of a Better Life.

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xyz-pharma-m-2025-04-14

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Azilsartan

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

66 API Suppliers, 19 USDMF, 10 JDMF, 11 EU WC, 17 KDMF, 7 NDC API, 35 Listed Suppliers, $ API Reference Price

66 API Suppliers
19 USDMF
10 JDMF
11 EU WC
17 KDMF
7 NDC API
35 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

7 Drugs in Development

7 Drugs in Development

INTERMEDIATES

33 Intermediate Suppliers

33 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

37 FDF Dossiers, 11 FDA Orange Book, 16 Europe, 6 Canada, 4 Listed Dossiers

37 FDF Dossiers
11 FDA Orange Book
16 Europe
6 Canada
4 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 40MG MEDOXOMIL, TABLET;ORAL - EQ 80MG MEDOXOMIL, TABLET;ORAL - EQ 40MG MEDOXOMIL;12.5MG, TABLET;ORAL - EQ 40MG MEDOXOMIL;25MG

TABLET;ORAL - EQ 40MG MEDOXOMIL
TABLET;ORAL - EQ 80MG MEDOXOMIL
TABLET;ORAL - EQ 40MG MEDOXOMIL;12.5MG
TABLET;ORAL - EQ 40MG MEDOXOMIL;25MG

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 14 SPI Pharma, 5 DKSH, 3 Faran Shimi Pharmaceutical, 4 Gangwal Healthcare, 1 Pfanstiehl, 1 ACG Worldwide, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 BASF, 10 Corel Pharma Chem, 3 DFE Pharma, 5 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 17 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 13 Roquette, 7 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 2 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

44 Coating Systems & Additives, 38 Fillers, Diluents & Binders, 20 Controlled & Modified Release, 19 Direct Compression, 18 Disintegrants & Superdisintegrants, 13 Thickeners and Stabilizers, 13 Chewable & Orodispersible Aids, 13 Taste Masking, 12 Granulation, 11 Lubricants & Glidants, 10 Co-Processed Excipients, 7 Film Formers & Plasticizers, 5 Empty Capsules, 5 Coloring Agents, 5 Rheology Modifiers, 4 Parenteral, 4 Vegetarian Capsules, 3 API Stability Enhancers, 2 Solubilizers, 2 Emulsifying Agents

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

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 17 News #PharmaBuzz

2 Data Compilation #PharmaFlow
17 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 10 Regulatory FDF Prices, 8 Annual Reports

1 US Medicaid Prescriptions
10 Regulatory FDF Prices
8 Annual Reports

MARKET PLACE

17 APIs

17 APIs

PATENTS & EXCLUSIVITIES

16 US Patents, 2 Health Canada Patents

16 US Patents
2 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 USP, 10 Others

5 USP
10 Others

$ API Ref.Price (USD/KG) : 1,422 Xls

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filter Applicant Reset all filters

11 All

01 2ALKEM LABS LTD

02 4AZURITY

03 3HETERO LABS LIMITED

04 2LUPIN LTD

filter Dosage Reset all filters

11 All

01 3TABLET

02 8TABLET;ORAL

filter Regulatory Info Reset all filters

11 All

01 2DISCN

02 6RX

03 3Blank

filter Brand Name Reset all filters

11 All

01 5AZILSARTAN MEDOXOMIL

02 2AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE

03 2EDARBI

04 2EDARBYCLOR

filter RLD Reset all filters

11 All

01 4No

02 4Yes

03 3Blank

List of Suppliers

Product Main Page

01

ALKEM LABS LTD

MAGHREB PHARMA

Not Confirmed

ALKEM LABS LTD

MAGHREB PHARMA

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

Brand Name : AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 40MG MEDOXOMIL;12.5MG

Approval Date : 2025-01-21

Application Number : 217490

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

Digital Content

Corporate PDF

02

ALKEM LABS LTD

MAGHREB PHARMA

Not Confirmed

ALKEM LABS LTD

MAGHREB PHARMA

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

Brand Name : AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 40MG MEDOXOMIL;25MG

Approval Date : 2025-01-21

Application Number : 217490

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

Digital Content

Corporate PDF

03

AZURITY

MAGHREB PHARMA

Not Confirmed

AZURITY

MAGHREB PHARMA

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

AZILSARTAN KAMEDOXOMIL

Brand Name : EDARBI

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 40MG MEDOXOMIL

Approval Date : 2011-02-25

Application Number : 200796

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

AZURITY

MAGHREB PHARMA

Not Confirmed

AZURITY

MAGHREB PHARMA

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

AZILSARTAN KAMEDOXOMIL

Brand Name : EDARBI

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 80MG MEDOXOMIL

Approval Date : 2011-02-25

Application Number : 200796

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

AZURITY

MAGHREB PHARMA

Not Confirmed

AZURITY

MAGHREB PHARMA

Not Confirmed

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Digital Content

RLD : Yes

TE Code : AB

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

Brand Name : EDARBYCLOR

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 40MG MEDOXOMIL;12.5MG

Approval Date : 2011-12-20

Application Number : 202331

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

AZURITY

MAGHREB PHARMA

Not Confirmed

AZURITY

MAGHREB PHARMA

Not Confirmed

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Digital Content

RLD : Yes

TE Code : AB

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

Brand Name : EDARBYCLOR

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 40MG MEDOXOMIL;25MG

Approval Date : 2011-12-20

Application Number : 202331

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

HETERO LABS LIMITED

MAGHREB PHARMA

Not Confirmed

HETERO LABS LIMITED

MAGHREB PHARMA

Not Confirmed

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Digital Content

RLD :

TE Code :

AZILSARTAN MEDOXOMIL

Brand Name : AZILSARTAN MEDOXOMIL

Dosage Form : TABLET

Dosage Strength : 80MG

Approval Date :

Application Number : 219062

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

HETERO LABS LIMITED

MAGHREB PHARMA

Not Confirmed

HETERO LABS LIMITED

MAGHREB PHARMA

Not Confirmed

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Digital Content

RLD :

TE Code :

AZILSARTAN MEDOXOMIL

Brand Name : AZILSARTAN MEDOXOMIL

Dosage Form : TABLET

Dosage Strength : 40MG

Approval Date :

Application Number : 219062

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

LUPIN LTD

MAGHREB PHARMA

Not Confirmed

LUPIN LTD

MAGHREB PHARMA

Not Confirmed

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Digital Content

RLD : No

TE Code :

AZILSARTAN KAMEDOXOMIL

Brand Name : AZILSARTAN MEDOXOMIL

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 40MG MEDOXOMIL

Approval Date : 2022-07-20

Application Number : 214489

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product Web Link

Digital Content

Corporate PDF

10

LUPIN LTD

MAGHREB PHARMA

Not Confirmed

LUPIN LTD

MAGHREB PHARMA

Not Confirmed

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Digital Content

RLD : No

TE Code :

AZILSARTAN KAMEDOXOMIL

Brand Name : AZILSARTAN MEDOXOMIL

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 80MG MEDOXOMIL

Approval Date : 2022-07-20

Application Number : 214489

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product Web Link

Digital Content

Corporate PDF

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