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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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USDMF

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JDMF

JDMFs Filed

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KDMF

KDMF

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NDC API

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VMF

NDC API

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EDQM

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Chemistry

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Also known as:
Molecular Formula
C13H20N6O4
Molecular Weight
324.34  g/mol
InChI Key
HDOVUKNUBWVHOX-QMMMGPOBSA-N

Valacyclovir
1 2D Structure

Valacyclovir

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
2.1.2 InChI
InChI=1S/C13H20N6O4/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)/t8-/m0/s1
2.1.3 InChI Key
HDOVUKNUBWVHOX-QMMMGPOBSA-N
2.1.4 Canonical SMILES
CC(C)C(C(=O)OCCOCN1C=NC2=C1NC(=NC2=O)N)N
2.1.5 Isomeric SMILES
CC(C)[C@@H](C(=O)OCCOCN1C=NC2=C1NC(=NC2=O)N)N
2.2 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 324.34 g/mol
Molecular Formula C13H20N6O4
XLogP3-0.5
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count6
Rotatable Bond Count8
Exact Mass324.15460314 g/mol
Monoisotopic Mass324.15460314 g/mol
Topological Polar Surface Area147 A^2
Heavy Atom Count23
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 Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameValtrex
PubMed HealthValacyclovir (By mouth)
Drug ClassesAntiviral
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; Oral
Strengtheq 500mg base; eq 1gm base
Market StatusPrescription
CompanyGlaxosmithkline

2 of 2  
Drug NameValtrex
PubMed HealthValacyclovir (By mouth)
Drug ClassesAntiviral
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; Oral
Strengtheq 500mg base; eq 1gm base
Market StatusPrescription
CompanyGlaxosmithkline

API SUPPLIERS

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01

LGM Pharma

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
LGM Pharma CB

02

Aurore Life Sciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IOPC
Not Confirmed
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Aurore Life Sciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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IOPC
Not Confirmed
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03

Exemed Pharmaceuticals

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IOPC
Not Confirmed
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04

Aurobindo Pharma Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IOPC
Not Confirmed
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05

Sibbiotech

Russia

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IOPC
Not Confirmed
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06

Piramal Pharma Solutions

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IOPC
Not Confirmed
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07

Jin Dun Medical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IOPC
Not Confirmed
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08

Amara Labs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IOPC
Not Confirmed
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09

Vital Laboratories Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IOPC
Not Confirmed
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10

Harman Finochem

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IOPC
Not Confirmed
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API Reference Price

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DT:19.12.2023 RE-IMPORT)VALACICLOVIR HCL","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"PHARMASCIENCE INC","supplierCountry":"INDIA","foreign_port":"MONTREAL, QC","customer":"MYLAN LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"2796.80","actualQuantity":"2796.8","unit":"KGS","unitRateFc":"164.5","totalValueFC":"466454.1","currency":"USD","unitRateINR":"14446.2","date":"13-Mar-2025","totalValueINR":"40403122.67","totalValueInUsd":"466454.1","indian_port":"Hyderabad Air","hs_no":"29335990","bill_no":"8871206","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"MONTREAL, QC","supplierAddress":"6111 ROYALMOUNT SUITE 100 MONTREAL CANADA H4P 2T4 SDNF Canada","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742409000,"product":"VALACICLOVIR HCL (VIDE SB NO:4270103, DT:29.09.2023. RE-IMPORT)VALACICLOVIR HCL","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"PHARMASCIENCE INC","supplierCountry":"INDIA","foreign_port":"MONTREAL-DORAVAL APT","customer":"MYLAN LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"220.29","actualQuantity":"220.288","unit":"KGS","unitRateFc":"164.5","totalValueFC":"36723.3","currency":"USD","unitRateINR":"14439.7","date":"20-Mar-2025","totalValueINR":"3180882.35","totalValueInUsd":"36723.3","indian_port":"Hyderabad Air","hs_no":"29335990","bill_no":"9002133","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"MONTREAL-DORAVAL APT","supplierAddress":"6111 ROYALMOUNT SUITE 100 MONTREAL CANADA-H4P 2T4 SDNF Canada","customerAddress":"564\/A\/22, ROAD NO.92"}]
04-Jan-2022
30-Apr-2025
KGS
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

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Quantity (KGS) & Unit rate (USD/KGS) over time

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API Imports and Exports

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Listed Dossiers

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Valacyclovir

Brand Name : Valacyclovir

Dosage Form : Tablet

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Valacyclovir

Dosage : Tablet

Dosage Strength : 500MG

Brand Name : Valacyclovir

Approval Date :

Application Number :

Registration Country : India

Octavius Pharma

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Valacyclovir

Brand Name : Valacyclovir

Dosage Form : Tablet

Dosage Strength : 1000MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Valacyclovir

Dosage : Tablet

Dosage Strength : 1000MG

Brand Name : Valacyclovir

Approval Date :

Application Number :

Registration Country : India

Octavius Pharma

03

Pharmathen SA

Greece
  • fda
  • EDQM
  • WHO-GMP

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

Flag Greece
Digital Content Digital Content

Regulatory Info :

Registration Country : Greece

Valacyclovir

Brand Name :

Dosage Form : Powder For Oral Suspen...

Dosage Strength : 50MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Greece

Pharmathen

03

Pharmathen SA

Greece
  • fda
  • EDQM
  • WHO-GMP

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

Flag Greece
Digital Content Digital Content

Packaging :

Regulatory Info :

Valacyclovir

Dosage : Powder For Oral Suspen...

Dosage Strength : 50MG/ML

Brand Name :

Approval Date :

Application Number :

Registration Country : Greece

Pharmathen

04

Pharmathen SA

Greece
  • fda
  • EDQM
  • WHO-GMP

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

Flag Greece
Digital Content Digital Content

Regulatory Info :

Registration Country : Greece

Valacyclovir

Brand Name :

Dosage Form : Powder For Oral Suspen...

Dosage Strength : 200MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Greece

Pharmathen

04

Pharmathen SA

Greece
  • fda
  • EDQM
  • WHO-GMP

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

Flag Greece
Digital Content Digital Content

Packaging :

Regulatory Info :

Valacyclovir

Dosage : Powder For Oral Suspen...

Dosage Strength : 200MG/ML

Brand Name :

Approval Date :

Application Number :

Registration Country : Greece

Pharmathen

05

Pharmathen SA

Greece
  • fda
  • EDQM
  • WHO-GMP

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

Flag Greece
Digital Content Digital Content

Regulatory Info : EU Approved

Registration Country : Greece

Valacyclovir

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Approved

Registration Country : Greece

Pharmathen

05

Pharmathen SA

Greece
  • fda
  • EDQM
  • WHO-GMP

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

Flag Greece
Digital Content Digital Content

Packaging :

Regulatory Info : EU Approved

Valacyclovir

Dosage : Film Coated Tablet

Dosage Strength : 500MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Greece

Pharmathen

06

Grupo Chemo

Costa Rica
IOPC
Not Confirmed
arrow

Grupo Chemo

Costa Rica
arrow
IOPC
Not Confirmed

Valacyclovir

Brand Name : valacyclovir CHEMO®

Dosage Form : COATED TABLET

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generics

Registration Country : Costa Rica

blank

06

Grupo Chemo

Costa Rica
IOPC
Not Confirmed
arrow

Grupo Chemo

Costa Rica
arrow
IOPC
Not Confirmed

Valacyclovir

Dosage : COATED TABLET

Dosage Strength : 500MG

Brand Name : valacyclovir CHEMO®

Approval Date :

Application Number :

Registration Country : Costa Rica

blank

07

IOPC
Not Confirmed
arrow
arrow
IOPC
Not Confirmed

Valacyclovir

Brand Name :

Dosage Form : Tablet

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

blank

07

IOPC
Not Confirmed
arrow
arrow
IOPC
Not Confirmed

Valacyclovir

Dosage : Tablet

Dosage Strength : 500MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

blank

08

IOPC
Not Confirmed
arrow
arrow
IOPC
Not Confirmed

Valacyclovir

Brand Name :

Dosage Form : Tablet

Dosage Strength : 1000MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

blank

08

IOPC
Not Confirmed
arrow
arrow
IOPC
Not Confirmed

Valacyclovir

Dosage : Tablet

Dosage Strength : 1000MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

blank

09

Neopharma

U.A.E
IOPC
Not Confirmed
arrow

Neopharma

U.A.E
arrow
IOPC
Not Confirmed

Valaciclovir Hcl

Brand Name : Virico

Dosage Form : Tablet

Dosage Strength : 500MG

Packaging : 4 x 10's

Approval Date :

Application Number :

Regulatory Info :

Registration Country : U.A.E

blank

09

Neopharma

U.A.E
IOPC
Not Confirmed
arrow

Neopharma

U.A.E
arrow
IOPC
Not Confirmed

Valaciclovir Hcl

Dosage : Tablet

Dosage Strength : 500MG

Brand Name : Virico

Approval Date :

Application Number :

Registration Country : U.A.E

blank

10

IOPC
Not Confirmed
arrow
arrow
IOPC
Not Confirmed

Valacyclovir

Brand Name :

Dosage Form : Lyophilised Injection

Dosage Strength : 20MG

Packaging : Vial

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

blank

10

IOPC
Not Confirmed
arrow
arrow
IOPC
Not Confirmed

Valacyclovir

Dosage : Lyophilised Injection

Dosage Strength : 20MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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Looking for / Valacyclovir API manufacturers, exporters & distributors?

Valacyclovir manufacturers, exporters & distributors 1

14

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

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

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

API | Excipient name

Valacyclovir

Valacyclovir Manufacturers

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

Valacyclovir Suppliers

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

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

Valacyclovir WC

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

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

Valacyclovir GMP

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

Valacyclovir CoA

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

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