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Chemistry

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Also known as: 169293-50-9, Nebivolol hcl, 2,2'-azanediylbis(1-(6-fluorochroman-2-yl)ethanol) hydrochloride, 152520-56-4, Rac nebivolol hydrochloride, R 065824 hydrochloride
Molecular Formula
C22H26ClF2NO4
Molecular Weight
441.9  g/mol
InChI Key
JWEXHQAEWHKGCW-UHFFFAOYSA-N

Nebivolol
A cardioselective ADRENERGIC BETA-1 RECEPTOR ANTAGONIST (beta-blocker) that functions as a VASODILATOR through the endothelial L-arginine/ NITRIC OXIDE system. It is used to manage HYPERTENSION and chronic HEART FAILURE in elderly patients.
1 2D Structure

Nebivolol

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-(6-fluoro-3,4-dihydro-2H-chromen-2-yl)-2-[[2-(6-fluoro-3,4-dihydro-2H-chromen-2-yl)-2-hydroxyethyl]amino]ethanol;hydrochloride
2.1.2 InChI
InChI=1S/C22H25F2NO4.ClH/c23-15-3-7-19-13(9-15)1-5-21(28-19)17(26)11-25-12-18(27)22-6-2-14-10-16(24)4-8-20(14)29-22;/h3-4,7-10,17-18,21-22,25-27H,1-2,5-6,11-12H2;1H
2.1.3 InChI Key
JWEXHQAEWHKGCW-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1CC2=C(C=CC(=C2)F)OC1C(CNCC(C3CCC4=C(O3)C=CC(=C4)F)O)O.Cl
2.2 Synonyms
2.2.1 MeSH Synonyms

1. 67555, R

2. Alpha,alpha'-(iminobis(methylene))bis(6-fluoro-3,4-dihydro)-2h-1-benzopyran-2-methanol

3. Bystolic

4. Hydrochloride, Nebivolol

5. Lobivon

6. Nebilet

7. Nebivolol

8. R 67555

9. R-67555

10. R67555

11. Silostar

2.2.2 Depositor-Supplied Synonyms

1. 169293-50-9

2. Nebivolol Hcl

3. 2,2'-azanediylbis(1-(6-fluorochroman-2-yl)ethanol) Hydrochloride

4. 152520-56-4

5. Rac Nebivolol Hydrochloride

6. R 065824 Hydrochloride

7. Nebilox

8. Rac-nebivolol Hcl

9. R-067555

10. Schembl514784

11. N-phenyliminodiaceticacid

12. Chembl1201731

13. Akos016006035

14. Ac-4233

15. Ac-5636

16. Ccg-214847

17. Ro67555

18. As-12100

19. Cs-0362720

20. Ft-0652243

21. Ft-0655833

22. 520n564

23. W-60374

24. J-010524

25. 1-(6-fluoro-3,4-dihydro-2h-chromen-2-yl)-2-[[2-(6-fluoro-3,4-dihydro-2h-chromen-2-yl)-2-hydroxyethyl]amino]ethanol;hydrochloride

26. 2h-1-benzopyran-2-methanol,a,a'-[iminobis(methylene)]bis[6-fluoro-3,4-dihydro-,hydrochloride(1:1)

27. Alpha,alpha'[iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2h-1-benzopyran-2-methanol]hydrochloride

2.3 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 441.9 g/mol
Molecular Formula C22H26ClF2NO4
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count7
Rotatable Bond Count6
Exact Mass441.1518423 g/mol
Monoisotopic Mass441.1518423 g/mol
Topological Polar Surface Area71 Ų
Heavy Atom Count30
Formal Charge0
Complexity483
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count4
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Adrenergic beta-1 Receptor Agonists

Compounds that bind to and activate ADRENERGIC BETA-1 RECEPTORS. (See all compounds classified as Adrenergic beta-1 Receptor Agonists.)


Antihypertensive Agents

Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS. (See all compounds classified as Antihypertensive Agents.)


Vasodilator Agents

Drugs used to cause dilation of the blood vessels. (See all compounds classified as Vasodilator Agents.)


4.2 FDA Pharmacological Classification
4.2.1 Pharmacological Classes
beta-Adrenergic Blocker [EPC]; Adrenergic beta-Antagonists [MoA]

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MAHARASHTRA","supplier":"ZHEJIANG AUSUN PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"58.00","actualQuantity":"58","unit":"KGS","unitRateFc":"1811.2","totalValueFC":"106267.1","currency":"USD","unitRateINR":"153681.5","date":"26-Aug-2024","totalValueINR":"8913526","totalValueInUsd":"106267.1","indian_port":"Indore-EPZ\/SEZ","hs_no":"29329990","bill_no":"1006181","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"N\/A","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724697000,"product":"NEBIVOLOL HYDROCHLORIDE","address":"98, GOVT.INDUSTRIAL AREA,","city":"MUMBAI.","supplier":"XXEJIXXG AXXUN XXARMXXEUTXXAL XX.LTX","supplierCountry":"CHINA","foreign_port":"HANGZHOU XIAOSHAN INTERNATIONAL APT, 33","customer":"AJANTA PHARMA LIMITED","customerCountry":"INDIA","quantity":"8.00","actualQuantity":"8","unit":"KGS","unitRateFc":"2310","totalValueFC":"18694","currency":"USD","unitRateINR":"196003.5","date":"27-Aug-2024","totalValueINR":"1568028","totalValueInUsd":"18694","indian_port":"Dahez-SEZ","hs_no":"29329990","bill_no":"1004233","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGZHOU XIAOSHAN INTERNATIONAL APT, 33","supplierAddress":"N\/A","customerAddress":"98, GOVT.INDUSTRIAL AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1727721000,"product":"NEBIVOLOL HYDROCHLORIDE","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. 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02-Jan-2021
28-Feb-2025
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - EQ 5MG BASE;80MG

USFDA APPLICATION NUMBER - 206302

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DOSAGE - TABLET;ORAL - EQ 10MG BASE

USFDA APPLICATION NUMBER - 21742

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DOSAGE - TABLET;ORAL - EQ 2.5MG BASE

USFDA APPLICATION NUMBER - 21742

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DOSAGE - TABLET;ORAL - EQ 20MG BASE

USFDA APPLICATION NUMBER - 21742

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DOSAGE - TABLET;ORAL - EQ 5MG BASE

USFDA APPLICATION NUMBER - 21742

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ABOUT THIS PAGE

Looking for 152520-56-4 / Nebivolol API manufacturers, exporters & distributors?

Nebivolol manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Nebivolol 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 Nebivolol manufacturer or Nebivolol supplier for your needs.

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

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

API | Excipient name

Nebivolol

Synonyms

169293-50-9, Nebivolol hcl, 2,2'-azanediylbis(1-(6-fluorochroman-2-yl)ethanol) hydrochloride, 152520-56-4, Rac nebivolol hydrochloride, R 065824 hydrochloride

Cas Number

152520-56-4

About Nebivolol

A cardioselective ADRENERGIC BETA-1 RECEPTOR ANTAGONIST (beta-blocker) that functions as a VASODILATOR through the endothelial L-arginine/ NITRIC OXIDE system. It is used to manage HYPERTENSION and chronic HEART FAILURE in elderly patients.

Nebivolol HCl Manufacturers

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

Nebivolol HCl Suppliers

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

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

Nebivolol HCl USDMF

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

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

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

Nebivolol HCl KDMF

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

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

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

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

Nebivolol HCl CEP

A Nebivolol HCl CEP of the European Pharmacopoeia monograph is often referred to as a Nebivolol HCl Certificate of Suitability (COS). The purpose of a Nebivolol HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nebivolol HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nebivolol HCl to their clients by showing that a Nebivolol HCl CEP has been issued for it. The manufacturer submits a Nebivolol HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nebivolol HCl CEP holder for the record. Additionally, the data presented in the Nebivolol HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nebivolol HCl DMF.

A Nebivolol HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nebivolol HCl CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Nebivolol HCl suppliers with CEP (COS) on PharmaCompass.

Nebivolol HCl WC

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

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

Nebivolol HCl 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 Nebivolol HCl as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Nebivolol HCl GMP

Nebivolol HCl 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 Nebivolol HCl 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 Nebivolol HCl GMP manufacturer or Nebivolol HCl GMP API supplier for your needs.

Nebivolol HCl CoA

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

Nebivolol HCl CoA mostly includes findings from lab analyses of a specific batch. For each Nebivolol HCl 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.

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