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    Chemistry

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    Also known as: Sacubitril valsartan sodium hydrate, Sacubitril mixture with valsartan, Wb8ft61183, Lcz 696, Sacubitril valsartan sodium hydrate (jan), Sacubitril valsartan sodium hydrate [jan]
    Molecular Formula
    C96H120N12Na6O21
    Molecular Weight
    1916.0  g/mol
    InChI Key
    ZASXKEGREHRXDL-CAWNUZPDSA-H
    FDA UNII
    WB8FT61183
    Sacubitril-Valsartan
    Sacubitril/Valsartan is a combination of sacubitril and valsartan with natriuretic and anti-hypertensive properties. Upon administration, sacubitril is metabolized by esterases to its active metabolite, LBQ657 (sacubitrilat), which inhibits neprilysin, a neutral endopeptidase that cleaves natriuretic peptides such as atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP), and c-type natriuretic peptide (CNP), as well as certain vasoconstricting peptides including as angiotensin I and II, and endothelin-1. Inhibition of neprilysin leads to increased concentrations of endogenous natriuretic peptides, which function to activate downstream receptors that promote vasodilation, natriuresis and diuresis, while simultaneously increasing the concentration of vasoconstricting peptides such as angiotensin II. Co-administration with valsartan, an angiotensin II receptor blocker, prevents the vasoconstrictive effects of neprilysin inhibition and promotes a decrease in vascular resistance and blood pressure.
    1 2D Structure

    Sacubitril-Valsartan

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    hexasodium;4-[[(2S,4R)-5-ethoxy-4-methyl-5-oxo-1-(4-phenylphenyl)pentan-2-yl]amino]-4-oxobutanoate;(2S)-3-methyl-2-[pentanoyl-[[4-[2-(1,2,3-triaza-4-azanidacyclopenta-2,5-dien-5-yl)phenyl]phenyl]methyl]amino]butanoate;pentahydrate
    2.1.2 InChI
    InChI=1S/2C24H29N5O3.2C24H29NO5.6Na.5H2O/c2*1-4-5-10-21(30)29(22(16(2)3)24(31)32)15-17-11-13-18(14-12-17)19-8-6-7-9-20(19)23-25-27-28-26-23;2*1-3-30-24(29)17(2)15-21(25-22(26)13-14-23(27)28)16-18-9-11-20(12-10-18)19-7-5-4-6-8-19;;;;;;;;;;;/h2*6-9,11-14,16,22H,4-5,10,15H2,1-3H3,(H2,25,26,27,28,31,32);2*4-12,17,21H,3,13-16H2,1-2H3,(H,25,26)(H,27,28);;;;;;;5*1H2/q;;;;6*+1;;;;;/p-6/t2*22-;2*17-,21+;;;;;;;;;;;/m0011.........../s1
    2.1.3 InChI Key
    ZASXKEGREHRXDL-CAWNUZPDSA-H
    2.1.4 Canonical SMILES
    CCCCC(=O)N(CC1=CC=C(C=C1)C2=CC=CC=C2C3=NN=N[N-]3)C(C(C)C)C(=O)[O-].CCCCC(=O)N(CC1=CC=C(C=C1)C2=CC=CC=C2C3=NN=N[N-]3)C(C(C)C)C(=O)[O-].CCOC(=O)C(C)CC(CC1=CC=C(C=C1)C2=CC=CC=C2)NC(=O)CCC(=O)[O-].CCOC(=O)C(C)CC(CC1=CC=C(C=C1)C2=CC=CC=C2)NC(=O)CCC(=O)[O-].O.O.O.O.O.[Na+].[Na+].[Na+].[Na+].[Na+].[Na+]
    2.1.5 Isomeric SMILES
    CCCCC(=O)N(CC1=CC=C(C=C1)C2=CC=CC=C2C3=NN=N[N-]3)[C@@H](C(C)C)C(=O)[O-].CCCCC(=O)N(CC1=CC=C(C=C1)C2=CC=CC=C2C3=NN=N[N-]3)[C@@H](C(C)C)C(=O)[O-].CCOC(=O)[C@H](C)C[C@@H](CC1=CC=C(C=C1)C2=CC=CC=C2)NC(=O)CCC(=O)[O-].CCOC(=O)[C@H](C)C[C@@H](CC1=CC=C(C=C1)C2=CC=CC=C2)NC(=O)CCC(=O)[O-].O.O.O.O.O.[Na+].[Na+].[Na+].[Na+].[Na+].[Na+]
    2.2 Other Identifiers
    2.2.1 UNII
    WB8FT61183
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 3-(1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-3'-methyl-2'-(pentanoyl(2'-(tetrazol-5-ylate)biphenyl-4'-ylmethyl)amino)butyrate

    2. Lcz 696

    3. Lcz-696

    4. Lcz696

    5. Sacubitril And Valsartan Drug Combination

    6. Sacubitril And Valsartan Sodium Anhydrous Drug Combination

    7. Sacubitril And Valsartan Sodium Hydrate Drug Combination

    8. Sacubitril Valsartan Drug Combination

    9. Sacubitril Valsartan Sodium Anhydrous

    10. Sacubitril Valsartan Sodium Hydrate

    11. Sacubitril-valsartan

    12. Sacubitril-valsartan Sodium Anhydrous Drug Combination

    13. Sacubitril-valsartan Sodium Hydrate Drug Combination

    14. Trisodium (3-(1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-3'-methyl-2'-(pentanoyl(2'-(tetrazol-5-ylate)biphenyl-4'-ylmethyl)amino)butyrate) Hemipentahydrate

    2.3.2 Depositor-Supplied Synonyms

    1. Sacubitril Valsartan Sodium Hydrate

    2. Sacubitril Mixture With Valsartan

    3. Wb8ft61183

    4. Lcz 696

    5. Sacubitril Valsartan Sodium Hydrate (jan)

    6. Sacubitril Valsartan Sodium Hydrate [jan]

    7. Entresto (tn)

    8. Unii-wb8ft61183

    9. Valsartan Mixture With Ahu-377

    10. Ex-a2849

    11. Mfcd29477717

    12. 3-(1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-3'-methyl-2'-(pentanoyl(2'-(tetrazol-5-ylate)biphenyl-4'-ylmethyl)amino)butyrate

    13. Ac-29037

    14. Sucabitril Valsartan Sodium Hydrate

    15. Trisodium (3-(1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-3'-methyl-2'-(pentanoyl(2'-(tetrazol-5-ylate)biphenyl-4'-ylmethyl)amino)butyrate) Hemipentahydrate

    16. D10226

    17. Valsartan Ahu-377 Sodium Hemipentahydrate

    18. Q27292546

    19. L-valine, N-(1-oxopentyl)-n-((2'-(2h-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-, Compd. With .alpha.-ethyl (.alpha.r,.gamma.s)-.gamma.-((3-carboxy-1-oxopropyl)amino)-.alpha.-methyl(1,1'-biphenyl)-4-pentanoate, Sodium Salt, Hydrate (2:2:6:5)

    20. L-valine, N-(1-oxopentyl)-n-((2'-(2h-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-, Compd. With Alpha-ethyl(alphar,gammas)-gamma-((3-carboxy-1-oxopropyl)amino)-alpha-methyl(1,1'-biphenyl)-4-pentanoate, Sodium Salt, Hydrate (2:2:6:5)

    2.4 Create Date
    2013-05-27
    3 Chemical and Physical Properties
    Molecular Weight 1916.0 g/mol
    Molecular Formula C96H120N12Na6O21
    Hydrogen Bond Donor Count7
    Hydrogen Bond Acceptor Count29
    Rotatable Bond Count40
    Exact Mass1915.8110694 g/mol
    Monoisotopic Mass1914.8077146 g/mol
    Topological Polar Surface Area396 Ų
    Heavy Atom Count135
    Formal Charge0
    Complexity1140
    Isotope Atom Count0
    Defined Atom Stereocenter Count6
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count15
    4 Drug and Medication Information
    4.1 Drug Indication

    Entresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Angiotensin Receptor Antagonists

    Agents that antagonize ANGIOTENSIN RECEPTORS. Many drugs in this class specifically target the ANGIOTENSIN TYPE 1 RECEPTOR. (See all compounds classified as Angiotensin Receptor Antagonists.)

    5.2 ATC Code

    C09DX04

    API Reference Price

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    03-Feb-2021
    09-Dec-2024
    KGS
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    Average Price (USD/KGS)

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    ABOUT THIS PAGE

    sacubitril valsartan sodium hydrate Manufacturers

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

    sacubitril valsartan sodium hydrate Suppliers

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

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

    sacubitril valsartan sodium hydrate USDMF

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

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

    click here to find a list of sacubitril valsartan sodium hydrate suppliers with USDMF on PharmaCompass.

    sacubitril valsartan sodium hydrate KDMF

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

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

    After submitting a sacubitril valsartan sodium hydrate 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 sacubitril valsartan sodium hydrate API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of sacubitril valsartan sodium hydrate suppliers with KDMF on PharmaCompass.

    sacubitril valsartan sodium hydrate WC

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

    click here to find a list of sacubitril valsartan sodium hydrate suppliers with Written Confirmation (WC) on PharmaCompass.

    sacubitril valsartan sodium hydrate 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 sacubitril valsartan sodium hydrate as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of sacubitril valsartan sodium hydrate suppliers with NDC on PharmaCompass.

    sacubitril valsartan sodium hydrate GMP

    sacubitril valsartan sodium hydrate 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 sacubitril valsartan sodium hydrate 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 sacubitril valsartan sodium hydrate GMP manufacturer or sacubitril valsartan sodium hydrate GMP API supplier for your needs.

    sacubitril valsartan sodium hydrate CoA

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

    sacubitril valsartan sodium hydrate CoA mostly includes findings from lab analyses of a specific batch. For each sacubitril valsartan sodium hydrate 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.

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