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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]

    API Reference Price

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    02-Jan-2021
    29-Nov-2024
    KGS
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    DOSAGE - TABLET;ORAL - EQ 5MG BASE;80MG

    USFDA APPLICATION NUMBER - 206302

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    DOSAGE - TABLET;ORAL - EQ 20MG BASE

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    DOSAGE - TABLET;ORAL - EQ 5MG BASE

    USFDA APPLICATION NUMBER - 21742

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    ABOUT THIS PAGE

    Nebivolol Hydrochloride Manufacturers

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

    Nebivolol Hydrochloride Suppliers

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

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

    Nebivolol Hydrochloride USDMF

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

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

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

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

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

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

    Nebivolol Hydrochloride CEP

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

    A Nebivolol Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nebivolol Hydrochloride 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 Hydrochloride suppliers with CEP (COS) on PharmaCompass.

    Nebivolol Hydrochloride WC

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

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

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

    Finished drug products

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

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

    Nebivolol Hydrochloride GMP

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

    Nebivolol Hydrochloride CoA

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

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