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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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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

56 API Suppliers, 17 USDMF, 10 JDMF, 11 EU WC, 15 KDMF, 7 NDC API, 36 Listed Suppliers, $ API Reference Price

56 API Suppliers
17 USDMF
10 JDMF
11 EU WC
15 KDMF
7 NDC API
36 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

7 Drugs in Development

7 Drugs in Development

INTERMEDIATES

33 Intermediates Suppliers

33 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

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

30 FDF Dossiers
6 FDA Orange Book
16 Europe
4 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

drugProductComposition
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, 13 SPI Pharma, 3 DKSH, 3 Faran Shimi Pharmaceutical, 7 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, 40 Fillers, Diluents & Binders, 23 Direct Compression, 21 Controlled & Modified Release, 15 Disintegrants & Superdisintegrants, 12 Co-Processed Excipients, 12 Taste Masking, 12 Granulation, 12 Thickeners and Stabilizers, 12 Lubricants & Glidants, 12 Chewable & Orodispersible Aids, 7 Film Formers & Plasticizers, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Parenteral, 3 Rheology Modifiers, 2 Emulsifying Agents, 1 Solubilizers

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 15 NEWS #PharmaBuzz

media
3 DATA COMPILATION #PharmaFlow
15 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 10 Finished Drug Prices, 8 Annual Reports

globalSalesInformation
1 US Medicaid Prescriptions
10 Finished Drug Prices
8 Annual Reports

MARKET PLACE

17 APIs

marketPlace
17 APIs

PATENTS & EXCLUSIVITIES

16 US Patents, 2 Health Canada Patents

patents
16 US Patents
2 Health Canada Patents

REF. STANDARDS & IMPURITIES

10 Others

otherSolutions
10 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 1,436

MARKET PLACE

API

FDF

33INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

7DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

36,008,755

Annual Reports (USD Million)

4,921

Finished Drug Prices

148 RELATED EXCIPIENT COMPANIES

250EXCIPIENTS BY APPLICATIONS

Chemistry

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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

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 Formula	C₃₀H₂₃KN₄O₈
Molecular Weight	606.6 g/mol
Hydrogen Bond Donor Count	0
Hydrogen Bond Acceptor Count	10
Rotatable Bond Count	10
Exact Mass	606.11529519 g/mol
Monoisotopic Mass	606.11529519 g/mol
Topological Polar Surface Area	129 Å²
Heavy Atom Count	43
Formal Charge	0
Complexity	1110
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

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]

API SUPPLIERS

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USDMF

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JDMF

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EU WC

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KDMF

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NDC API

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Listed Suppliers

01

LGM Pharma

U.S.A

PharmaVenue

Not Confirmed

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

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U.S.A

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Digital Content

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.

02

Metrochem API Private Limited

India

PharmaVenue

Not Confirmed

Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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India

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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

03

Ami Lifesciences Private Limited

India

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Not Confirmed

AMI Lifesciences is Driven by Chemistry. Powered by People.

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India

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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.

04

HRV Global Life Sciences

India

PharmaVenue

Not Confirmed

HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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India

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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.

05

Jinan Tantu Chemicals

China

CPhI China

Exhibiting

Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

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China

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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.

06

Shandong Loncom Pharmaceutical

China

PharmaVenue

Not Confirmed

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

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China

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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.

Shandong Loncom Pharmaceutical company banner

07

Alkem Laboratories

India

PharmaVenue

Not Confirmed

08

Aurobindo Pharma Limited

India

PharmaVenue

Not Confirmed

09

Jiangsu Zhongbang Pharmaceutical Co...

China

PharmaVenue

Not Confirmed

Jiangsu Zhongbang Pharmaceutical Co...

China

PharmaVenue

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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China

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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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10

Maithili Life Sciences

India

PharmaVenue

Not Confirmed

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API Reference Price

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C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"BUCHAREST, OTOPENI","customer":"GEDEON RICHTER","customerCountry":"ROMANIA","quantity":"54.00","actualQuantity":"54","unit":"KGS","unitRateFc":"4363","totalValueFC":"227031.9","currency":"USD","unitRateINR":352325,"date":"23-Sep-2024","totalValueINR":"19025550","totalValueInUsd":"227031.9","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"4264294","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ROMANIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. 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":""}]

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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01

Azurity Pharma

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DOSAGE - TABLET;ORAL - EQ 40MG MEDOXOMIL

USFDA APPLICATION NUMBER - 200796

DOSAGE - TABLET;ORAL - EQ 80MG MEDOXOMIL

USFDA APPLICATION NUMBER - 200796

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

USFDA APPLICATION NUMBER - 202331

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

USFDA APPLICATION NUMBER - 202331

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ABOUT THIS PAGE

Azilsartan Medoxomil Manufacturers

A Azilsartan Medoxomil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azilsartan Medoxomil, including repackagers and relabelers. The FDA regulates Azilsartan Medoxomil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azilsartan Medoxomil 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 Medoxomil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Azilsartan Medoxomil Suppliers

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

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

Azilsartan Medoxomil USDMF

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

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

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

Azilsartan Medoxomil 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 Medoxomil Drug Master File in Japan (Azilsartan Medoxomil JDMF) empowers Azilsartan Medoxomil 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 Medoxomil JDMF during the approval evaluation for pharmaceutical products. At the time of Azilsartan Medoxomil 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 Medoxomil suppliers with JDMF on PharmaCompass.

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

After submitting a Azilsartan Medoxomil 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 Medoxomil API can apply through the Korea Drug Master File (KDMF).

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

Azilsartan Medoxomil WC

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

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

Azilsartan Medoxomil 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 Medoxomil as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Azilsartan Medoxomil 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 Medoxomil 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 Medoxomil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Azilsartan Medoxomil NDC to their finished compounded human drug products, they may choose to do so.

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

Azilsartan Medoxomil GMP

Azilsartan Medoxomil 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 Medoxomil 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 Medoxomil GMP manufacturer or Azilsartan Medoxomil GMP API supplier for your needs.

Azilsartan Medoxomil CoA

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

Azilsartan Medoxomil CoA mostly includes findings from lab analyses of a specific batch. For each Azilsartan Medoxomil 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 Medoxomil may be tested according to a variety of international standards, such as European Pharmacopoeia (Azilsartan Medoxomil EP), Azilsartan Medoxomil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Azilsartan Medoxomil 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.

Find Azilsartan manufacturers, exporters & distributors on PharmaCompass

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

56 API Suppliers

17 USDMF

10 JDMF

11 EU WC

15 KDMF

7 NDC API

36 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

7 Drugs in Development

INTERMEDIATES

33 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

30 FDF Dossiers

6 FDA Orange Book

16 Europe

4 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

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15 Disintegrants & Superdisintegrants

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