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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]

KDMF

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Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

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아질사르탄메독소밀칼륨

Registrant Name : (주)에스지바이오켐

Registration Date : 2021-07-13

Registration Number : Su434-15-ND(1)

Manufacturer Name : Ami Lifesciences Private Lim...

Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...

AMI Lifesciences

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Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

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아질사르탄메독소밀칼륨

Registrant Name : Aging Life Science Co., Ltd.

Registration Date : 2020-07-09

Registration Number : Su434-15-ND

Manufacturer Name : Ami Lifesciences Private Lim...

Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City: Karakhadi-391 450, Di...

AMI Lifesciences

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

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Azilsartan Medoxomil Potassium

Registrant Name : Ace Biopharm Co., Ltd.

Registration Date : 2025-03-14

Registration Number : Su289-30-ND

Manufacturer Name : Shandong Loncom Pharmaceutic...

Manufacturer Address : No 127, Qizhong Avenue, Yanbei Subdistrict, Qihe County, Dezhou City, Shandong Provin...

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아질사르탄메독소밀칼륨

Registrant Name : Sungwoo Chemical Co., Ltd.

Registration Date : 2024-07-02

Registration Number : Su473-30-ND

Manufacturer Name : Alembic Pharmaceuticals Limi...

Manufacturer Address : Plot No. 842-843, Village-Karakadi, Taluka-Padra, District-Vadodara - 391 450, Gujara...

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Honour Lab

India
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Honour Lab

India
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아질사르탄메독소밀칼륨

Registrant Name : Ace Biopharm Co., Ltd.

Registration Date : 2023-10-04

Registration Number : Thu21-18-ND(2)

Manufacturer Name : Honour Lab Limited(Unit-III)

Manufacturer Address : Plot No.4, Hetero Infrastructure SEZ Ltd, N. Narasapuram Village, Nakkapalli Mandal, ...

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Inist

South Korea
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Inist

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Azilsartan Medoxomil

Registrant Name : Inistesti Co., Ltd.

Registration Date : 2025-01-14

Registration Number : 2220-19-ND

Manufacturer Name : Inistesti Co., Ltd.

Manufacturer Address : 54 Osongsaengmyeong 6-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do

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Azilsartan Medoxomil Potassium

Registrant Name : 엠피크코리아(주)

Registration Date : 2025-03-18

Registration Number : 수812-26-ND

Manufacturer Name : Jiangxi Synergy Pharmaceutic...

Manufacturer Address : No.888, Tiangong Avenue, Jiangxi Fengxin Industrial Park, Fengxin County, 330700, Yic...

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Korea Biochem Pharm

South Korea
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Korea Biochem Pharm

South Korea
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아질사르탄메독소밀칼륨

Registrant Name : Korea Biochem Pharmaceutical Co., Ltd.

Registration Date : 2024-01-10

Registration Number : 2152-22-ND

Manufacturer Name : Korea Biochem Pharmaceutical...

Manufacturer Address : 204 Sandan-gil, Jeonui-myeon, Sejong Special Self-Governing City @Plot No.2, APIIC In...

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Lupin Ltd

India
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Lupin Ltd

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Azilsartan Medoxomil Potassium

Registrant Name : Klasia Co., Ltd.

Registration Date : 2024-10-07

Registration Number : No. 758-15-ND

Manufacturer Name : Lupin Manufacturing Solution...

Manufacturer Address : Plot No.130, Road No.11, Jawaharlal Nehru Pharma City, Parawada(M), Anakapalli Dist....

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Azilsartan medoxomil potassium

Registrant Name : Celltrion Pharmaceutical Co., Ltd.

Registration Date : 2017-04-07

Registration Number : No. 108-5-ND

Manufacturer Name : Takeda Pharmaceutical Compan...

Manufacturer Address : 4720, Takeda, Mitsui, Hikari, Yamaguchi, 743-8502, Japan

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09-Mar-2021
06-Mar-2025
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ABOUT THIS PAGE

Looking for 863031-24-7 / Azilsartan API manufacturers, exporters & distributors?

Azilsartan manufacturers, exporters & distributors 1

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

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Azilsartan manufacturer or Azilsartan supplier.

PharmaCompass also assists you with knowing the Azilsartan API Price utilized in the formulation of products. Azilsartan API Price is not always fixed or binding as the Azilsartan Price is obtained through a variety of data sources. The Azilsartan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Azilsartan

Synonyms

863031-24-7, Azilsartan (medoxomil monopotassium), Azilsartan kamedoxomil, Azilsartan medoxomil monopotassium, Bcp11249, Sb19561

Cas Number

863031-24-7

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.
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