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Also known as: 863031-24-7, Azilsartan (medoxomil monopotassium), Azilsartan kamedoxomil, Azilsartan medoxomil monopotassium, Bcp11249, Sb19561
Molecular Formula
C30H23KN4O8
Molecular Weight
606.6  g/mol
InChI Key
IHWFKDWIUSZLCJ-UHFFFAOYSA-M

Azilsartan
1 2D Structure

Azilsartan

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
potassium;(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-3-[[4-[2-(5-oxo-1-oxa-4-aza-2-azanidacyclopent-3-en-3-yl)phenyl]phenyl]methyl]benzimidazole-4-carboxylate
2.1.2 InChI
InChI=1S/C30H24N4O8.K/c1-3-38-28-31-23-10-6-9-22(27(35)39-16-24-17(2)40-30(37)41-24)25(23)34(28)15-18-11-13-19(14-12-18)20-7-4-5-8-21(20)26-32-29(36)42-33-26;/h4-14H,3,15-16H2,1-2H3,(H,32,33,36);/q;+1/p-1
2.1.3 InChI Key
IHWFKDWIUSZLCJ-UHFFFAOYSA-M
2.1.4 Canonical SMILES
CCOC1=NC2=CC=CC(=C2N1CC3=CC=C(C=C3)C4=CC=CC=C4C5=NC(=O)O[N-]5)C(=O)OCC6=C(OC(=O)O6)C.[K+]
2.2 Synonyms
2.2.1 Depositor-Supplied Synonyms

1. 863031-24-7

2. Azilsartan (medoxomil Monopotassium)

3. Azilsartan Kamedoxomil

4. Azilsartan Medoxomil Monopotassium

5. Bcp11249

6. Sb19561

7. Hy-17458

8. Potassium;(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-3-[[4-[2-(5-oxo-1-oxa-4-aza-2-azanidacyclopent-3-en-3-yl)phenyl]phenyl]methyl]benzimidazole-4-carboxylate

9. Potassium 3-(4'-((2-ethoxy-7-(((5-methyl-2-oxo-1,3-dioxol-4-yl)methoxy)carbonyl)-1h-benzo[d]imidazol-1-yl)methyl)-[1,1'-biphenyl]-2-yl)-5-oxo-5h-1,2,4-oxadiazol-2-ide

2.3 Create Date
2015-09-21
3 Chemical and Physical Properties
Molecular Weight 606.6 g/mol
Molecular Formula C30H23KN4O8
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count10
Rotatable Bond Count10
Exact Mass606.11529519 g/mol
Monoisotopic Mass606.11529519 g/mol
Topological Polar Surface Area129 Ų
Heavy Atom Count43
Formal Charge0
Complexity1110
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Pharmacology and Biochemistry
4.1 FDA Pharmacological Classification
4.1.1 Pharmacological Classes
Angiotensin 2 Type 1 Receptor Antagonists [MoA]; Decreased Blood Pressure [PE]; Angiotensin 2 Receptor Blocker [EPC]

Listed Suppliers

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LGM Pharma

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Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Azilsartan

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
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Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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Azilsartan

About the Company :

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product ...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
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Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

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Azilsartan

About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...

Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.
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Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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Azilsartan

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
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Virtual BoothJinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

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Azilsartan

About the Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include c...

Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include customized R&D as well as the production of small molecule pharmaceutical intermediates and Active Pharmaceutical Ingredients (APIs) for both international and domestic pharmaceutical firms. Our capabilities span from laboratory-scale kilograms to commercial ton-scale production. Additionally, we are committed to independent research and development, as well as the production and sales of high-end pharmaceutical intermediates and API products.
Jinan Tantu Chemicals

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Virtual BoothShandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

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Azilsartan

About the Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development...

Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development Zone, Shandong Province, Shandong Loncom has operational API pilot tests and production bases adhering to international standards. With 13 production lines dedicated to oral solid preparations, oral liquid preparations and API, it is actively expanding its preparation workshops for small-volume injections, soft capsules, eye drops, topical medicines and innovative drug R&D centres.
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Azilsartan

About the Company : Back in the year 1973, a team of individuals came up with such an idea – The idea called Alkem. Looking back at our 5 decades, illustrious journey, that one small idea has Not on...

Back in the year 1973, a team of individuals came up with such an idea – The idea called Alkem. Looking back at our 5 decades, illustrious journey, that one small idea has Not only triggered us to become one of India’s largest generic and specialty pharmaceutical company but also, create a foothold in over 40 countries. 29% of our revenue is generated via offshore sales and it has consistently been ranked amongst the top ten pharmaceutical companies in India. They have 20 manufacturing facilities at multiple locations in India and the United States of America.
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Azilsartan

About the Company : Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company comme...

Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company commenced operations in 1988-89 with a single unit manufacturing Semi-Synthetic Penicillin (SSP) at Pondicherry. Aurobindo Pharma became a public company in 1992 and listed its shares in the Indian stock exchanges in 1995. In addition to being the market leader in Semi-Synthetic Penicillins, it has a presence in key therapeutic segments such as neurosciences, cardiovascular, anti-retrovirals, anti-diabetics, gastroenterology and cephalosporins, among others.
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Azilsartan

About the Company : Jiangsu Zhongbang Pharmaceutical Co., Ltd. is a wholly-owned subsidiary of Red Sun Group. Company has been founded since 2001 and occupied 100,000m2. Company has 80 million RMB reg...

Jiangsu Zhongbang Pharmaceutical Co., Ltd. is a wholly-owned subsidiary of Red Sun Group. Company has been founded since 2001 and occupied 100,000m2. Company has 80 million RMB registered capital and plan to have a total investment of 200 million RMB. Company has 168 employees at present, in which there are 34 employees with Bachelor’s Degree or above, 12 employees with Master’s Degree or above, each kind of professional talents have occupied over 60% of the total employees. Company has got China GMP certificate since 2006 and currently has one GMP plant for API and one GMP plant for solid finished products. There are two production lines in API GMP plants with annual capacity of 50 tons API. There are equipment for tablets, capsules and granules in solid finished products. Company has set up qualified documentation systems according to China GMP and Europe and USA C-GMP. Company has the plan to pass COS and FDA authentication both around 2014. Company also pays serious attention on public welfare and concerns on green energy conservation and environmental protection undertaking.
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About the Company : MAITHILI is a group of companies based in India (MAM, MLS, MAC, MAT,SGG) and Singapore(MITCO). Maithili Life Sciences (MLS) is a Contract Research Organization headquartered in Hy...

MAITHILI is a group of companies based in India (MAM, MLS, MAC, MAT,SGG) and Singapore(MITCO). Maithili Life Sciences (MLS) is a Contract Research Organization headquartered in Hyderabad(lab scale). API operations are supported by a manufacturing unit with cGMP facility designed in accordance with international standards with a built up space of around 4,35,600 sq ft located in Tirupati,AP,India(pilot scale).
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AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728239400,"product":"(INVOICE NO: PI\/3042100563 DT: 30.09.2024) ORGANIC CHEMICAL: AZILSARTAN MEDOXOMIL POTASSIUM IH","address":"SURVEY NO.91, OPP.NAVIN FLOURINE","city":"SURAT\/GUJARAT","supplier":"CTX LIFESCIENCES","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"AS PER INVOICE","customerCountry":"BANGLADESH","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"703","totalValueFC":"34396.7","currency":"USD","unitRateINR":57804.699999999997,"date":"07-Oct-2024","totalValueINR":"2890235","totalValueInUsd":"34396.7","indian_port":"Bombay Air","hs_no":"29393000","bill_no":"4625265","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"SURVEY NO.91, OPP.NAVIN FLOURINE, SURAT\/GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731695400,"product":"ORGANIC CHEMICAL AZILSARTAN MEDOXOMIL POTASSIUM IH","address":"SURVEY NO.91, OPP.NAVIN FLOURINE","city":"SURAT\/GUJARAT","supplier":"CTX LIFESCIENCES","supplierCountry":"INDIA","foreign_port":"MEXICO CITY","customer":"AS PER INVOICE","customerCountry":"MEXICO","quantity":"0.03","actualQuantity":"0.03","unit":"KGS","unitRateFc":"800","totalValueFC":"23.8","currency":"USD","unitRateINR":66880,"date":"16-Nov-2024","totalValueINR":"2006.4","totalValueInUsd":"23.8","indian_port":"Bombay Air","hs_no":"29393000","bill_no":"5647426","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"SURVEY NO.91, OPP.NAVIN FLOURINE, SURAT\/GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732559400,"product":"(INVOICE NO: PI\/3042100728 DT: 22.11.2024) ORGANIC CHEMICAL: AZILSARTAN MEDOXOMIL POTASSIUM IH","address":"SURVEY NO.91, OPP.NAVIN FLOURINE","city":"SURAT\/GUJARAT","supplier":"CTX LIFESCIENCES","supplierCountry":"INDIA","foreign_port":"KATHMANDU - TRIBHUVA","customer":"AS PER INVOICE","customerCountry":"NEPAL","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"165000","totalValueFC":"976.4","currency":"INR","unitRateINR":164800,"date":"26-Nov-2024","totalValueINR":"82400","totalValueInUsd":"976.4","indian_port":"Bombay Air","hs_no":"29393000","bill_no":"5922200","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"NEPAL","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"SURVEY NO.91, OPP.NAVIN FLOURINE, SURAT\/GUJARAT","customerAddress":""}]
18-Jan-2021
26-Nov-2024
KGS
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

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FDF Dossiers

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01

Biotech Showcase
Not Confirmed
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Biotech Showcase
Not Confirmed

AZILSARTAN KAMEDOXOMIL

Brand Name : EDARBI

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 80MG MEDOXOMIL

Packaging :

Approval Date : 2011-02-25

Application Number : 200796

Regulatory Info : RX

Registration Country : USA

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02

Bausch Health

Canada
Biotech Showcase
Not Confirmed
arrow

Bausch Health

Canada
arrow
Biotech Showcase
Not Confirmed

AZILSARTAN MEDOXOMIL (AZILSARTAN MEDOXOMIL POTASSIUM)

Brand Name : EDARBYCLOR

Dosage Form : TABLET

Dosage Strength : 40MG

Packaging :

Approval Date :

Application Number : 2397765

Regulatory Info :

Registration Country : Canada

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03

Lupin Ltd

India
Biotech Showcase
Not Confirmed
arrow

Lupin Ltd

India
arrow
Biotech Showcase
Not Confirmed

AZILSARTAN KAMEDOXOMIL

Brand Name : AZILSARTAN MEDOXOMIL

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 40MG MEDOXOMIL

Packaging :

Approval Date : 2022-07-20

Application Number : 214489

Regulatory Info : DISCN

Registration Country : USA

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04

Serene Pharma

Uzbekistan
Biotech Showcase
Not Confirmed
arrow

Serene Pharma

Uzbekistan
arrow
Biotech Showcase
Not Confirmed

Azilsartan

Brand Name : Azisar

Dosage Form : Tablet

Dosage Strength : 40MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Uzbekistan

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05

Biotech Showcase
Not Confirmed
arrow
arrow
Biotech Showcase
Not Confirmed

azilsartanmedoxomilkalium

Brand Name : Edarbi

Dosage Form : TABLET

Dosage Strength : 80 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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06

Biotech Showcase
Not Confirmed
arrow
arrow
Biotech Showcase
Not Confirmed

azilsartanmedoxomilkalium

Brand Name : Ipreziv

Dosage Form : TABLET

Dosage Strength : 20 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

blank

07

Biotech Showcase
Not Confirmed
arrow
arrow
Biotech Showcase
Not Confirmed

azilsartanmedoxomilkalium

Brand Name : Ipreziv

Dosage Form : TABLET

Dosage Strength : 40 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

blank

08

Biotech Showcase
Not Confirmed
arrow
arrow
Biotech Showcase
Not Confirmed

Azilsartanum medoxomilum

Brand Name : Edarbi

Dosage Form : Tablet

Dosage Strength : 20mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

09

Biotech Showcase
Not Confirmed
arrow
arrow
Biotech Showcase
Not Confirmed

Azilsartanum medoxomilum

Brand Name : Edarbi

Dosage Form : Tablet

Dosage Strength : 40mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

10

Biotech Showcase
Not Confirmed
arrow
arrow
Biotech Showcase
Not Confirmed

Azilsartanum medoxomilum; Chlortalidonum

Brand Name : Edarbyclor

Dosage Form : Filmtabl

Dosage Strength : 40/12.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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FDA Orange Book

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01

AZURITY

U.S.A
BIO Partnering at JPM
Not Confirmed
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AZURITY

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

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 :

blank

02

AZURITY

U.S.A
BIO Partnering at JPM
Not Confirmed
arrow

AZURITY

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

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 :

blank

03

AZURITY

U.S.A
BIO Partnering at JPM
Not Confirmed
arrow

AZURITY

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

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 :

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04

AZURITY

U.S.A
BIO Partnering at JPM
Not Confirmed
arrow

AZURITY

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

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 :

blank

05

LUPIN LTD

India
BIO Partnering at JPM
Not Confirmed
arrow

LUPIN LTD

India
arrow
BIO Partnering at JPM
Not Confirmed

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 :

blank

06

LUPIN LTD

India
BIO Partnering at JPM
Not Confirmed
arrow

LUPIN LTD

India
arrow
BIO Partnering at JPM
Not Confirmed

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 :

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Europe

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01

BIO Partnering at JPM
Not Confirmed
arrow
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BIO Partnering at JPM
Not Confirmed

azilsartanmedoxomilkalium

Brand Name : Edarbi

Dosage Form : TABLET

Dosage Strength : 80 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

blank

02

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

azilsartanmedoxomilkalium

Brand Name : Edarbi

Dosage Form : TABLET

Dosage Strength : 20 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

blank

03

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

azilsartanmedoxomilkalium

Brand Name : Ipreziv

Dosage Form : TABLET

Dosage Strength : 20 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

blank

04

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

azilsartanmedoxomilkalium

Brand Name : Ipreziv

Dosage Form : TABLET

Dosage Strength : 80 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

blank

05

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

azilsartanmedoxomilkalium

Brand Name : Ipreziv

Dosage Form : TABLET

Dosage Strength : 40 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

blank

06

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Azilsartanum medoxomilum

Brand Name : Edarbi

Dosage Form : Tablet

Dosage Strength : 40mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

07

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Azilsartanum medoxomilum

Brand Name : Edarbi

Dosage Form : Tablet

Dosage Strength : 40mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

08

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Azilsartanum medoxomilum

Brand Name : Edarbi

Dosage Form : Tablet

Dosage Strength : 80mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

09

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Azilsartanum medoxomilum; Chlortalidonum

Brand Name : Edarbyclor

Dosage Form : Filmtabl

Dosage Strength : 40/12.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

10

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Azilsartanum medoxomilum; Chlortalidonum

Brand Name : Edarbyclor

Dosage Form : Filmtabl

Dosage Strength : 40/12.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - EQ 40MG MEDOXOMIL

USFDA APPLICATION NUMBER - 200796

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DOSAGE - TABLET;ORAL - EQ 80MG MEDOXOMIL

USFDA APPLICATION NUMBER - 200796

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DOSAGE - TABLET;ORAL - EQ 40MG MEDOXOMIL;12.5...DOSAGE - TABLET;ORAL - EQ 40MG MEDOXOMIL;12.5MG

USFDA APPLICATION NUMBER - 202331

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DOSAGE - TABLET;ORAL - EQ 40MG MEDOXOMIL;25MG

USFDA APPLICATION NUMBER - 202331

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ABOUT THIS PAGE

Azilsartan Manufacturers

A Azilsartan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azilsartan, including repackagers and relabelers. The FDA regulates Azilsartan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azilsartan API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Azilsartan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Azilsartan Suppliers

A Azilsartan supplier is an individual or a company that provides Azilsartan active pharmaceutical ingredient (API) or Azilsartan finished formulations upon request. The Azilsartan suppliers may include Azilsartan API manufacturers, exporters, distributors and traders.

click here to find a list of Azilsartan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Azilsartan USDMF

A Azilsartan DMF (Drug Master File) is a document detailing the whole manufacturing process of Azilsartan active pharmaceutical ingredient (API) in detail. Different forms of Azilsartan DMFs exist exist since differing nations have different regulations, such as Azilsartan USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Azilsartan DMF submitted to regulatory agencies in the US is known as a USDMF. Azilsartan USDMF includes data on Azilsartan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Azilsartan USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Azilsartan suppliers with USDMF on PharmaCompass.

Azilsartan JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Azilsartan Drug Master File in Japan (Azilsartan JDMF) empowers Azilsartan API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Azilsartan JDMF during the approval evaluation for pharmaceutical products. At the time of Azilsartan JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Azilsartan suppliers with JDMF on PharmaCompass.

Azilsartan KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Azilsartan Drug Master File in Korea (Azilsartan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Azilsartan. The MFDS reviews the Azilsartan KDMF as part of the drug registration process and uses the information provided in the Azilsartan KDMF to evaluate the safety and efficacy of the drug.

After submitting a Azilsartan KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Azilsartan API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Azilsartan suppliers with KDMF on PharmaCompass.

Azilsartan WC

A Azilsartan written confirmation (Azilsartan WC) is an official document issued by a regulatory agency to a Azilsartan manufacturer, verifying that the manufacturing facility of a Azilsartan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Azilsartan APIs or Azilsartan finished pharmaceutical products to another nation, regulatory agencies frequently require a Azilsartan WC (written confirmation) as part of the regulatory process.

click here to find a list of Azilsartan suppliers with Written Confirmation (WC) on PharmaCompass.

Azilsartan NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Azilsartan as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Azilsartan API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Azilsartan as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Azilsartan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Azilsartan NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Azilsartan suppliers with NDC on PharmaCompass.

Azilsartan GMP

Azilsartan Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Azilsartan GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Azilsartan GMP manufacturer or Azilsartan GMP API supplier for your needs.

Azilsartan CoA

A Azilsartan CoA (Certificate of Analysis) is a formal document that attests to Azilsartan's compliance with Azilsartan specifications and serves as a tool for batch-level quality control.

Azilsartan CoA mostly includes findings from lab analyses of a specific batch. For each Azilsartan CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Azilsartan may be tested according to a variety of international standards, such as European Pharmacopoeia (Azilsartan EP), Azilsartan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Azilsartan USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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