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| Molecular Weight | 360.80 g/mol |
|---|---|
| Molecular Formula | C13H21ClN6O4 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 8 |
| Exact Mass | 360.1312809 g/mol |
| Monoisotopic Mass | 360.1312809 g/mol |
| Topological Polar Surface Area | 147 A^2 |
| Heavy Atom Count | 24 |
| Formal Charge | 0 |
| Complexity | 483 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 2 | |
|---|---|
| Drug Name | Valacyclovir hydrochloride |
| Drug Label | VALTREX (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 Ingredient | Valacyclovir hydrochloride |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 500mg base; eq 1gm base |
| Market Status | Prescription |
| Company | Wockhardt; Mylan Pharms; Ranbaxy; Apotex; Aurobindo Pharma; Sandoz; Cipla; Roxane; Watson Labs; Teva Pharms; Jubilant Generics; Dr Reddys Labs; Mylan |
| 2 of 2 | |
|---|---|
| Drug Name | Valacyclovir hydrochloride |
| Drug Label | VALTREX (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 Ingredient | Valacyclovir hydrochloride |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 500mg base; eq 1gm base |
| Market Status | Prescription |
| Company | Wockhardt; Mylan Pharms; Ranbaxy; Apotex; Aurobindo Pharma; Sandoz; Cipla; Roxane; Watson Labs; Teva Pharms; Jubilant Generics; Dr Reddys Labs; Mylan |
API SUPPLIERS
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USDMF
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17794
Submission : 2004-10-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17223
Submission : 2003-03-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20659
Submission : 2007-07-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20454
Submission : 2007-04-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18940
Submission : 2005-10-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16300
Submission : 2002-12-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21284
Submission : 2008-01-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-13
Pay. Date : 2019-08-09
DMF Number : 17943
Submission : 2004-12-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21010
Submission : 2007-10-26
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20278
Submission : 2007-02-09
Status : Inactive
Type : II
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Valaciclovir Hydrochloride Hydrate
Certificate Number : CEP 2013-318 - Rev 02
Status : Valid
Issue Date : 2024-02-02
Type : Chemical
Substance Number : 2751
Certificate Number : CEP 2022-123 - Rev 01
Status : Valid
Issue Date : 2025-06-03
Type : Chemical
Substance Number : 1768
Valaciclovir Hydrochloride Hydrate, Site Khazipa...
Certificate Number : CEP 2024-045 - Rev 00
Status : Valid
Issue Date : 2024-06-19
Type : Chemical
Substance Number : 2751
Valaciclovir Hydrochloride, Process B
Certificate Number : CEP 2024-169 - Rev 00
Status : Valid
Issue Date : 2024-09-25
Type : Chemical
Substance Number : 1768
Valaciclovir Hydrochloride, Form II
Certificate Number : R1-CEP 2013-180 - Rev 00
Status : Valid
Issue Date : 2020-01-09
Type : Chemical
Substance Number : 1768
Valaciclovir Hydrochloride Hydrate
Certificate Number : CEP 2018-102 - Rev 03
Status : Valid
Issue Date : 2025-04-25
Type : Chemical
Substance Number : 2751
Valaciclovir Hydrochloride Hydrate, Site-II
Certificate Number : CEP 2024-054 - Rev 01
Status : Valid
Issue Date : 2024-12-13
Type : Chemical
Substance Number : 2751
Valaciclovir Hydrochloride Hydrate
Certificate Number : CEP 2017-255 - Rev 02
Status : Valid
Issue Date : 2024-11-15
Type : Chemical
Substance Number : 2751
Valaciclovir Hydrochloride Hydrate
Certificate Number : CEP 2014-086 - Rev 03
Status : Valid
Issue Date : 2024-07-19
Type : Chemical
Substance Number : 2751
Certificate Number : R0-CEP 2017-003 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2018-02-13
Type : Chemical
Substance Number : 1768
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Average Price (USD/KGS) |
Number of Transactions |
|---|
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Drugs in Development
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RLD : No
TE Code :
Brand Name : VALACYCLOVIR HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 500MG BASE
Approval Date : 2011-03-16
Application Number : 90370
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : VALACYCLOVIR HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1GM BASE
Approval Date : 2011-03-16
Application Number : 90370
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : VALACYCLOVIR HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 500MG BASE
Approval Date : 2010-05-24
Application Number : 77135
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : VALACYCLOVIR HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1GM BASE
Approval Date : 2010-05-24
Application Number : 77135
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code : AB
Brand Name : VALTREX
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 500MG BASE
Approval Date : 1995-06-23
Application Number : 20487
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : No
TE Code : AB
Brand Name : VALACYCLOVIR HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 500MG BASE
Approval Date : 2015-04-08
Application Number : 203047
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : VALACYCLOVIR HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1GM BASE
Approval Date : 2015-04-08
Application Number : 203047
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : VALACYCLOVIR HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1GM BASE
Approval Date : 2012-04-03
Application Number : 201506
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
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Regulatory Info :
Registration Country : Sweden
valaciklovirhydroklorid, hydratiserad
Brand Name : Valaciclovir Orion
Dosage Form : FILMDRAGERAD TABLETT
Dosage Strength : 1000 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
valaciklovirhydroklorid, vattenfri
Brand Name : Valtrex
Dosage Form : FILMDRAGERAD TABLETT
Dosage Strength : 500 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
valaciklovirhydroklorid, vattenfri
Brand Name : Valtrex
Dosage Form : FILMDRAGERAD TABLETT
Dosage Strength : 500 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
valaciklovirhydroklorid, vattenfri
Brand Name : Valtrex
Dosage Form : FILMDRAGERAD TABLETT
Dosage Strength : 500 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
valaciklovirhydroklorid, vattenfri
Brand Name : Valtrex
Dosage Form : FILMDRAGERAD TABLETT
Dosage Strength : 500 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
valaciklovirhydroklorid, vattenfri
Brand Name : Valtrex
Dosage Form : FILMDRAGERAD TABLETT
Dosage Strength : 250 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
valaciklovirhydroklorid, vattenfri
Brand Name : Valtrex
Dosage Form : FILMDRAGERAD TABLETT
Dosage Strength : 500 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
valaciklovirhydroklorid, hydratiserad
Brand Name : Valaciclovir BMM Pharma
Dosage Form : FILMDRAGERAD TABLETT
Dosage Strength : 500 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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Regulatory Info :
Registration Country : Sweden
valaciklovirhydroklorid, vattenfri
Brand Name : Valavir
Dosage Form : FILMDRAGERAD TABLETT
Dosage Strength : 500 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
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Regulatory Info :
Registration Country : Sweden
valaciklovirhydroklorid, vattenfri
Brand Name : Valtrex
Dosage Form : FILMDRAGERAD TABLETT
Dosage Strength : 500 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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DOSAGE - TABLET;ORAL - EQ 1GM BASE
USFDA APPLICATION NUMBER - 20487
DOSAGE - TABLET;ORAL - EQ 500MG BASE
USFDA APPLICATION NUMBER - 20487
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PharmaCompass offers a list of Valacyclovir 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 Valacyclovir Hydrochloride manufacturer or Valacyclovir Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Valacyclovir Hydrochloride manufacturer or Valacyclovir Hydrochloride supplier.
PharmaCompass also assists you with knowing the Valacyclovir Hydrochloride API Price utilized in the formulation of products. Valacyclovir Hydrochloride API Price is not always fixed or binding as the Valacyclovir Hydrochloride Price is obtained through a variety of data sources. The Valacyclovir Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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 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.
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).
