Find Valganciclovir Hydrochloride manufacturers, exporters & distributors on PharmaCompass

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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

USDMF

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Pharmathen Sa

Greece
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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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Digital Content Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2017-11-07

Pay. Date : 2017-04-28

DMF Number : 31546

Submission : 2017-05-12

Status : Active

Type : II

Pharmathen

02

Specialty & Agro Chemical
Not Confirmed

03

Specialty & Agro Chemical
Not Confirmed

03

Specialty & Agro Chemical
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2015-11-16

Pay. Date : 2015-11-10

DMF Number : 26314

Submission : 2012-08-24

Status : Active

Type : II

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04

Hetero Drugs Ltd

India

USDMF

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Specialty & Agro Chemical
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2013-06-28

Pay. Date : 2012-12-07

DMF Number : 26079

Submission : 2012-05-23

Status : Active

Type : II

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05

Olon Spa

Italy

USDMF

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Not Confirmed

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08

Specialty & Agro Chemical
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2013-03-06

Pay. Date : 2012-11-06

DMF Number : 23859

Submission : 2010-05-27

Status : Active

Type : II

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09

Specialty & Agro Chemical
Not Confirmed

09

Specialty & Agro Chemical
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2016-02-04

Pay. Date : 2015-09-28

DMF Number : 23322

Submission : 2009-11-30

Status : Active

Type : II

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CEP/COS

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Specialty & Agro Chemical
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Specialty & Agro Chemical
Not Confirmed

Certificate Number : CEP 2023-414 - Rev 00

Status : Valid

Issue Date : 2025-05-02

Type : Chemical

Substance Number : 2930

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03

Specialty & Agro Chemical
Not Confirmed
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Specialty & Agro Chemical
Not Confirmed

Certificate Number : CEP 2022-398 - Rev 01

Status : Valid

Issue Date : 2025-02-26

Type : Chemical

Substance Number : 2930

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04

Specialty & Agro Chemical
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Specialty & Agro Chemical
Not Confirmed

Certificate Number : CEP 2024-111 - Rev 00

Status : Valid

Issue Date : 2024-04-24

Type : Chemical

Substance Number : 2930

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API Reference Price

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LTD","customerCountry":"INDIA","quantity":"90.32","actualQuantity":"90.32","unit":"KGS","unitRateFc":"975.9","totalValueFC":"88280.1","currency":"USD","unitRateINR":"85000","date":"03-Feb-2025","totalValueINR":"7677200","totalValueInUsd":"88280.1","indian_port":"Vizag-HIPL SEZ","hs_no":"29335990","bill_no":"8152674","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"7-2-A2, HETERO CORPORATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1746210600,"product":"VALGANCICLOVIR HCL IH","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"HETERO DRUGS LTD UNIT IX","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO DRUGS LTD","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"993.6","totalValueFC":"24941.1","currency":"USD","unitRateINR":"85000","date":"03-May-2025","totalValueINR":"2125000","totalValueInUsd":"24941.1","indian_port":"Vizag-HIPL SEZ","hs_no":"29335990","bill_no":"9848753","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"7-2-A2, HETERO CORPORATE,"}]
02-Feb-2022
16-May-2025
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Looking for / Valganciclovir Hydrochloride API manufacturers, exporters & distributors?

Valganciclovir Hydrochloride manufacturers, exporters & distributors 1

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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 Manufacturers

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

Valganciclovir Suppliers

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

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

Valganciclovir USDMF

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

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

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

Valganciclovir CEP

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

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

Valganciclovir WC

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

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

Valganciclovir 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 as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Valganciclovir GMP

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

Valganciclovir CoA

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

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