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    Chemistry

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    Also known as:
    Molecular Formula
    C14H23ClN6O5
    Molecular Weight
    390.82  g/mol
    InChI Key
    ZORWARFPXPVJLW-MTFPJWTKSA-N
    Valganciclovir Hydrochloride
    1 2D Structure

    Valganciclovir Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [2-[(2-amino-6-oxo-3H-purin-9-yl)methoxy]-3-hydroxypropyl] (2S)-2-amino-3-methylbutanoate;hydrochloride
    2.1.2 InChI
    InChI=1S/C14H22N6O5.ClH/c1-7(2)9(15)13(23)24-4-8(3-21)25-6-20-5-17-10-11(20)18-14(16)19-12(10)22;/h5,7-9,21H,3-4,6,15H2,1-2H3,(H3,16,18,19,22);1H/t8?,9-;/m0./s1
    2.1.3 InChI Key
    ZORWARFPXPVJLW-MTFPJWTKSA-N
    2.1.4 Canonical SMILES
    CC(C)C(C(=O)OCC(CO)OCN1C=NC2=C1NC(=NC2=O)N)N.Cl
    2.1.5 Isomeric SMILES
    CC(C)[C@@H](C(=O)OCC(CO)OCN1C=NC2=C1NC(=NC2=O)N)N.Cl
    2.2 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 390.82 g/mol
    Molecular Formula C14H23ClN6O5
    Hydrogen Bond Donor Count5
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count9
    Exact Mass390.1418455 g/mol
    Monoisotopic Mass390.1418455 g/mol
    Topological Polar Surface Area167 A^2
    Heavy Atom Count26
    Formal Charge0
    Complexity528
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameValcyte
    PubMed HealthValganciclovir (By mouth)
    Drug ClassesAntiviral
    Drug LabelValcyte contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV.Valcyte is av...
    Active IngredientValganciclovir hydrochloride
    Dosage FormTablet; For solution
    RouteOral
    Strength50mg/ml; eq 450mg base
    Market StatusPrescription
    CompanyHoffmann La Roche

    2 of 4  
    Drug NameValganciclovir hydrochloride
    Drug LabelValcyte contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV.Valcyte is av...
    Active IngredientValganciclovir hydrochloride
    Dosage FormTablet
    Routeoral
    Strength450mg
    Market StatusTentative Approval
    CompanyRanbaxy

    3 of 4  
    Drug NameValcyte
    PubMed HealthValganciclovir (By mouth)
    Drug ClassesAntiviral
    Drug LabelValcyte contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV.Valcyte is av...
    Active IngredientValganciclovir hydrochloride
    Dosage FormTablet; For solution
    RouteOral
    Strength50mg/ml; eq 450mg base
    Market StatusPrescription
    CompanyHoffmann La Roche

    4 of 4  
    Drug NameValganciclovir hydrochloride
    Drug LabelValcyte contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV.Valcyte is av...
    Active IngredientValganciclovir hydrochloride
    Dosage FormTablet
    Routeoral
    Strength450mg
    Market StatusTentative Approval
    CompanyRanbaxy

    API Reference Price

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    06-Jan-2022
    26-May-2025
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    01

    Brand Name : Valcyte/Cymevene

    Ganciclovir and Valganciclovir

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    KY/TN Water Professionals
    Not Confirmed

    Brand Name : Valcyte/Cymevene

    Switzerland
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    Not Confirmed

    Roche

    Ganciclovir and Valganciclovir

    Main Therapeutic Indication : Immunology (Organ Transplant, Arthr...

    Currency : USD

    2015 Revenue in Millions : 733

    2014 Revenue in Millions : 373

    Growth (%) : -49%

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    01

    CHEPLAPHARM

    VALGANCICLOVIR HYDROCHLORIDE

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    Not Confirmed

    CHEPLAPHARM

    Germany
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    Not Confirmed

    Patent Expiration Date : 2027-12-11

    VALGANCICLOVIR HYDROCHLORIDE

    US Patent Number : 9642911

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 22257

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2027-12-11

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    02

    CHEPLAPHARM

    VALGANCICLOVIR HYDROCHLORIDE

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    KY/TN Water Professionals
    Not Confirmed

    CHEPLAPHARM

    Germany
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    Not Confirmed

    Patent Expiration Date : 2027-12-11

    VALGANCICLOVIR HYDROCHLORIDE

    US Patent Number : 8889109

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 22257

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2027-12-11

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    ANALYTICAL

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    ABOUT THIS PAGE

    Looking for / Valganciclovir Hydrochloride API manufacturers, exporters & distributors?

    Valganciclovir Hydrochloride manufacturers, exporters & distributors 1

    71

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

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

    API | Excipient name

    Valganciclovir Hydrochloride

    Hoffmann-La Roche brand of valganciclovir hydrochloride Manufacturers

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

    Hoffmann-La Roche brand of valganciclovir hydrochloride Suppliers

    A Hoffmann-La Roche brand of valganciclovir hydrochloride supplier is an individual or a company that provides Hoffmann-La Roche brand of valganciclovir hydrochloride active pharmaceutical ingredient (API) or Hoffmann-La Roche brand of valganciclovir hydrochloride finished formulations upon request. The Hoffmann-La Roche brand of valganciclovir hydrochloride suppliers may include Hoffmann-La Roche brand of valganciclovir hydrochloride API manufacturers, exporters, distributors and traders.

    click here to find a list of Hoffmann-La Roche brand of valganciclovir hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Hoffmann-La Roche brand of valganciclovir hydrochloride USDMF

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

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

    click here to find a list of Hoffmann-La Roche brand of valganciclovir hydrochloride suppliers with USDMF on PharmaCompass.

    Hoffmann-La Roche brand of valganciclovir hydrochloride CEP

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

    A Hoffmann-La Roche brand of valganciclovir hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hoffmann-La Roche brand of valganciclovir 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 Hoffmann-La Roche brand of valganciclovir hydrochloride suppliers with CEP (COS) on PharmaCompass.

    Hoffmann-La Roche brand of valganciclovir hydrochloride WC

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

    click here to find a list of Hoffmann-La Roche brand of valganciclovir hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

    Hoffmann-La Roche brand of valganciclovir 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 Hoffmann-La Roche brand of valganciclovir hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Hoffmann-La Roche brand of valganciclovir 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 Hoffmann-La Roche brand of valganciclovir 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 Hoffmann-La Roche brand of valganciclovir hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hoffmann-La Roche brand of valganciclovir hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Hoffmann-La Roche brand of valganciclovir hydrochloride suppliers with NDC on PharmaCompass.

    Hoffmann-La Roche brand of valganciclovir hydrochloride GMP

    Hoffmann-La Roche brand of valganciclovir 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 Hoffmann-La Roche brand of valganciclovir 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 Hoffmann-La Roche brand of valganciclovir hydrochloride GMP manufacturer or Hoffmann-La Roche brand of valganciclovir hydrochloride GMP API supplier for your needs.

    Hoffmann-La Roche brand of valganciclovir hydrochloride CoA

    A Hoffmann-La Roche brand of valganciclovir hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Hoffmann-La Roche brand of valganciclovir hydrochloride's compliance with Hoffmann-La Roche brand of valganciclovir hydrochloride specifications and serves as a tool for batch-level quality control.

    Hoffmann-La Roche brand of valganciclovir hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Hoffmann-La Roche brand of valganciclovir 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.

    Hoffmann-La Roche brand of valganciclovir hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Hoffmann-La Roche brand of valganciclovir hydrochloride EP), Hoffmann-La Roche brand of valganciclovir hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hoffmann-La Roche brand of valganciclovir 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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