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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
    16-May-2025
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    DR REDDYS

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    CPhI WW Frankfurt
    Booth #9.1B48
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    TE Code : AB

    VALGANCICLOVIR HYDROCHLORIDE

    Brand Name : VALGANCICLOVIR HYDROCHLORIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 450MG BASE

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    Application Number : 203511

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    DR REDDYS

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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    RLD : No

    TE Code : AB

    VALGANCICLOVIR HYDROCHLORIDE

    Brand Name : VALGANCICLOVIR HYDROCHLORIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 450MG BASE

    Approval Date : 2017-12-12

    Application Number : 206876

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Booth # 9.1F6 & 9.1G41
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    Virtual BoothSynergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.

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    RLD : No

    TE Code : AB

    VALGANCICLOVIR HYDROCHLORIDE

    Brand Name : VALGANCICLOVIR HYDROCHLORIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 450MG BASE

    Approval Date : 2014-11-04

    Application Number : 200790

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    GRANULES

    India
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    Booth #H9.1A48
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    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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    RLD : No

    TE Code : AB

    VALGANCICLOVIR HYDROCHLORIDE

    Brand Name : VALGANCICLOVIR HYDROCHLORIDE

    Dosage Form : FOR SOLUTION;ORAL

    Dosage Strength : 50MG/ML

    Approval Date : 2020-01-31

    Application Number : 213306

    RX/OTC/DISCN : RX

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    AJANTA PHARMA LTD

    India
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    RLD : No

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    VALGANCICLOVIR HYDROCHLORIDE

    Brand Name : VALGANCICLOVIR HYDROCHLORIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 450MG BASE

    Approval Date : 2019-12-26

    Application Number : 212234

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Germany
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    VALGANCICLOVIR HYDROCHLORIDE

    Brand Name : VALCYTE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 450MG BASE

    Approval Date : 2001-03-29

    Application Number : 21304

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    RLD : Yes

    TE Code : AB

    VALGANCICLOVIR HYDROCHLORIDE

    Brand Name : VALCYTE

    Dosage Form : FOR SOLUTION;ORAL

    Dosage Strength : 50MG/ML

    Approval Date : 2009-08-28

    Application Number : 22257

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    CIPLA

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    VALGANCICLOVIR HYDROCHLORIDE

    Brand Name : VALGANCICLOVIR HYDROCHLORIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 450MG BASE

    Approval Date : 2018-11-09

    Application Number : 209672

    RX/OTC/DISCN : DISCN

    RLD : No

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    HETERO LABS LTD V

    India
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    HETERO LABS LTD V

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    RLD : No

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    VALGANCICLOVIR HYDROCHLORIDE

    Brand Name : VALGANCICLOVIR HYDROCHLORIDE

    Dosage Form : FOR SOLUTION;ORAL

    Dosage Strength : 50MG/ML

    Approval Date : 2022-10-04

    Application Number : 211475

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    MSN

    India
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    RLD : No

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    VALGANCICLOVIR HYDROCHLORIDE

    Brand Name : VALGANCICLOVIR HYDROCHLORIDE

    Dosage Form : FOR SOLUTION;ORAL

    Dosage Strength : 50MG/ML

    Approval Date : 2022-02-17

    Application Number : 210169

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Europe

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    Pharmathen Sa

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    Booth #3.0C52
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    Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

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    Regulatory Info : Cancelled

    Registration Country : Spain

    Valganciclovir Hydrochloride

    Brand Name : Valganciclovir Pharmathen

    Dosage Form : Film Coated Tablet

    Dosage Strength : 450MG

    Packaging :

    Approval Date : 2018-12-21

    Application Number : 83204

    Regulatory Info : Cancelled

    Registration Country : Spain

    Pharmathen

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    2Care4 Aps

    Denmark
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Valganciclovir Hydrochloride

    Brand Name : Valganciclovir 2Care4

    Dosage Form : Film Coated Tablet

    Dosage Strength : 450mg

    Packaging :

    Approval Date : 13/03/2019

    Application Number : 20181123000031

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    Cipla Europe Nv

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    Regulatory Info : Approved

    Registration Country : Sweden

    Valganciclovir Hydrochloride

    Brand Name : Valganciclovir Cipla

    Dosage Form : Film Coated Tablet

    Dosage Strength : 450mg

    Packaging :

    Approval Date : 20/07/2016

    Application Number : 20150327000017

    Regulatory Info : Approved

    Registration Country : Sweden

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    Kern Pharma Sl

    Spain
    FNCE
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    Kern Pharma Sl

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    Regulatory Info : Authorized

    Registration Country : Spain

    Valganciclovir Hydrochloride

    Brand Name : Valganciclovir Kern Pharma

    Dosage Form : Film Coated Tablet

    Dosage Strength : 450MG

    Packaging :

    Approval Date : 2017-10-25

    Application Number : 82549

    Regulatory Info : Authorized

    Registration Country : Spain

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    Medartuum Ab

    Sweden
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    Regulatory Info : Deregistered

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    Valganciclovir Hydrochloride

    Brand Name : Valcyte

    Dosage Form : Film Coated Tablet

    Dosage Strength : 450mg

    Packaging :

    Approval Date : 05/06/2013

    Application Number : 20121124000012

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    Orifarm Ab

    Denmark
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    Regulatory Info : Deregistered

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    Valganciclovir Hydrochloride

    Brand Name : Valcyte

    Dosage Form : Film Coated Tablet

    Dosage Strength : 450mg

    Packaging :

    Approval Date : 28/05/2013

    Application Number : 20120904000020

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    Orifarm Ab

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    Regulatory Info : Deregistered

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    Valganciclovir Hydrochloride

    Brand Name : Valganciclovir Orifarm

    Dosage Form : Film Coated Tablet

    Dosage Strength : 450mg

    Packaging :

    Approval Date : 27/02/2019

    Application Number : 20181011000044

    Regulatory Info : Deregistered

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    Sandoz Pharmaceuticals Sa

    Switzerland
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    Regulatory Info : Cancelled

    Registration Country : Spain

    Valganciclovir

    Brand Name : Valganciclovir Sandoz

    Dosage Form : Film Coated Tablet

    Dosage Strength : 450MG

    Packaging :

    Approval Date : 2014-12-26

    Application Number : 79348

    Regulatory Info : Cancelled

    Registration Country : Spain

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    Teva Sweden Ab

    Israel
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    Teva Sweden Ab

    Israel
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    Regulatory Info : Approved

    Registration Country : Sweden

    Valganciclovir Hydrochloride

    Brand Name : Valganciclovir Teva

    Dosage Form : Film Coated Tablet

    Dosage Strength : 450mg

    Packaging :

    Approval Date : 30/01/2014

    Application Number : 20121211000017

    Regulatory Info : Approved

    Registration Country : Sweden

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    Teva Pharma Slu

    Israel
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    Regulatory Info : Authorized

    Registration Country : Spain

    Valganciclovir

    Brand Name : Valgancyclovir Teva

    Dosage Form : Film Coated Tablet

    Dosage Strength : 450MG

    Packaging :

    Approval Date : 2014-06-30

    Application Number : 78709

    Regulatory Info : Authorized

    Registration Country : Spain

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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.

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

    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

    Valganciclovir Hydrochloride Manufacturers

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

    Valganciclovir Hydrochloride Suppliers

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

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

    Valganciclovir Hydrochloride USDMF

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

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

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

    Valganciclovir Hydrochloride CEP

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

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

    Valganciclovir Hydrochloride WC

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

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

    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 Valganciclovir Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Valganciclovir Hydrochloride GMP

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

    Valganciclovir Hydrochloride CoA

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

    Valganciclovir Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each 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.

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