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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

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]

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07-Jan-2021
21-Dec-2024
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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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