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    Chemistry

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    Also known as:
    Molecular Formula
    C13H21ClN6O4
    Molecular Weight
    360.80  g/mol
    InChI Key
    ZCDDBUOENGJMLV-QRPNPIFTSA-N
    Valacyclovir Hydrochloride
    1 2D Structure

    Valacyclovir Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-[(2-amino-6-oxo-3H-purin-9-yl)methoxy]ethyl (2S)-2-amino-3-methylbutanoate;hydrochloride
    2.1.2 InChI
    InChI=1S/C13H20N6O4.ClH/c1-7(2)8(14)12(21)23-4-3-22-6-19-5-16-9-10(19)17-13(15)18-11(9)20;/h5,7-8H,3-4,6,14H2,1-2H3,(H3,15,17,18,20);1H/t8-;/m0./s1
    2.1.3 InChI Key
    ZCDDBUOENGJMLV-QRPNPIFTSA-N
    2.1.4 Canonical SMILES
    CC(C)C(C(=O)OCCOCN1C=NC2=C1NC(=NC2=O)N)N.Cl
    2.1.5 Isomeric SMILES
    CC(C)[C@@H](C(=O)OCCOCN1C=NC2=C1NC(=NC2=O)N)N.Cl
    2.2 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 360.80 g/mol
    Molecular Formula C13H21ClN6O4
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count8
    Exact Mass360.1312809 g/mol
    Monoisotopic Mass360.1312809 g/mol
    Topological Polar Surface Area147 A^2
    Heavy Atom Count24
    Formal Charge0
    Complexity483
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameValacyclovir hydrochloride
    Drug LabelVALTREX (valacyclovir hydrochloride) is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir.VALTREX Caplets are for oral administration. Each caplet contains valacyclovir hydrochloride equivalent to 500mg or 1gram valacycl...
    Active IngredientValacyclovir hydrochloride
    Dosage FormTablet
    RouteOral
    Strengtheq 500mg base; eq 1gm base
    Market StatusPrescription
    CompanyWockhardt; Mylan Pharms; Ranbaxy; Apotex; Aurobindo Pharma; Sandoz; Cipla; Roxane; Watson Labs; Teva Pharms; Jubilant Generics; Dr Reddys Labs; Mylan

    2 of 2  
    Drug NameValacyclovir hydrochloride
    Drug LabelVALTREX (valacyclovir hydrochloride) is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir.VALTREX Caplets are for oral administration. Each caplet contains valacyclovir hydrochloride equivalent to 500mg or 1gram valacycl...
    Active IngredientValacyclovir hydrochloride
    Dosage FormTablet
    RouteOral
    Strengtheq 500mg base; eq 1gm base
    Market StatusPrescription
    CompanyWockhardt; Mylan Pharms; Ranbaxy; Apotex; Aurobindo Pharma; Sandoz; Cipla; Roxane; Watson Labs; Teva Pharms; Jubilant Generics; Dr Reddys Labs; Mylan

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LIMITED","customerCountry":"INDIA","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"301","totalValueFC":"22844.7","currency":"USD","unitRateINR":"25389.4","date":"16-May-2024","totalValueINR":"1904201.25","totalValueInUsd":"22844.7","indian_port":"Ahmedabad Air","hs_no":"29349990","bill_no":"3516510","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"SAN JOSE","supplierAddress":"EDIFIDO NETPHARMA, CRTA DEFUENCARRAL 22, 28108 MADRIDSPAIN ES","customerAddress":"708, TIMES SQUARE ARCADE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715797800,"product":"VALACYCLOVIR HYDROCHLORIDE USP","address":"708, TIMES SQUARE ARCADE,","city":"AHMEDABAD","supplier":"MAPBIOPHARMA S.L","supplierCountry":"INDIA","foreign_port":"SAN JOSE","customer":"SKJ HEALTHCARE PRIVATE LIMITED","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"289","totalValueFC":"29245.3","currency":"USD","unitRateINR":"24377.2","date":"16-May-2024","totalValueINR":"2437715","totalValueInUsd":"29245.3","indian_port":"Ahmedabad Air","hs_no":"29349990","bill_no":"3516510","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"SAN JOSE","supplierAddress":"EDIFIDO NETPHARMA, CRTA DEFUENCARRAL 22, 28108 MADRIDSPAIN ES","customerAddress":"708, TIMES SQUARE ARCADE,"}]
    05-Jan-2021
    31-Dec-2024
    KGS
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    Average Price (USD/KGS)

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - EQ 1GM BASE

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    ABOUT THIS PAGE

    Valacyclovir Hydrochloride Manufacturers

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

    Valacyclovir Hydrochloride Suppliers

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

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

    Valacyclovir Hydrochloride USDMF

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

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

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

    Valacyclovir Hydrochloride JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Valacyclovir Hydrochloride Drug Master File in Japan (Valacyclovir Hydrochloride JDMF) empowers Valacyclovir Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Valacyclovir Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Valacyclovir Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Valacyclovir Hydrochloride suppliers with JDMF on PharmaCompass.

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

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

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

    Valacyclovir Hydrochloride CEP

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

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

    Valacyclovir Hydrochloride WC

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

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

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

    Finished drug products

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

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

    Valacyclovir Hydrochloride GMP

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

    Valacyclovir Hydrochloride CoA

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

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

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