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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 |
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INTERMEDIATE SUPPLIERS
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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 Valtrex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Valtrex, including repackagers and relabelers. The FDA regulates Valtrex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Valtrex 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 Valtrex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Valtrex supplier is an individual or a company that provides Valtrex active pharmaceutical ingredient (API) or Valtrex finished formulations upon request. The Valtrex suppliers may include Valtrex API manufacturers, exporters, distributors and traders.
click here to find a list of Valtrex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Valtrex DMF (Drug Master File) is a document detailing the whole manufacturing process of Valtrex active pharmaceutical ingredient (API) in detail. Different forms of Valtrex DMFs exist exist since differing nations have different regulations, such as Valtrex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Valtrex DMF submitted to regulatory agencies in the US is known as a USDMF. Valtrex USDMF includes data on Valtrex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Valtrex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Valtrex 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 Valtrex Drug Master File in Japan (Valtrex JDMF) empowers Valtrex 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 Valtrex JDMF during the approval evaluation for pharmaceutical products. At the time of Valtrex 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 Valtrex 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 Valtrex Drug Master File in Korea (Valtrex KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Valtrex. The MFDS reviews the Valtrex KDMF as part of the drug registration process and uses the information provided in the Valtrex KDMF to evaluate the safety and efficacy of the drug.
After submitting a Valtrex 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 Valtrex API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Valtrex suppliers with KDMF on PharmaCompass.
A Valtrex CEP of the European Pharmacopoeia monograph is often referred to as a Valtrex Certificate of Suitability (COS). The purpose of a Valtrex CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Valtrex EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Valtrex to their clients by showing that a Valtrex CEP has been issued for it. The manufacturer submits a Valtrex CEP (COS) as part of the market authorization procedure, and it takes on the role of a Valtrex CEP holder for the record. Additionally, the data presented in the Valtrex CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Valtrex DMF.
A Valtrex CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Valtrex 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 Valtrex suppliers with CEP (COS) on PharmaCompass.
A Valtrex written confirmation (Valtrex WC) is an official document issued by a regulatory agency to a Valtrex manufacturer, verifying that the manufacturing facility of a Valtrex active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Valtrex APIs or Valtrex finished pharmaceutical products to another nation, regulatory agencies frequently require a Valtrex WC (written confirmation) as part of the regulatory process.
click here to find a list of Valtrex 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 Valtrex as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Valtrex 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 Valtrex 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 Valtrex and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Valtrex NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Valtrex suppliers with NDC on PharmaCompass.
Valtrex 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 Valtrex 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 Valtrex GMP manufacturer or Valtrex GMP API supplier for your needs.
A Valtrex CoA (Certificate of Analysis) is a formal document that attests to Valtrex's compliance with Valtrex specifications and serves as a tool for batch-level quality control.
Valtrex CoA mostly includes findings from lab analyses of a specific batch. For each Valtrex 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.
Valtrex may be tested according to a variety of international standards, such as European Pharmacopoeia (Valtrex EP), Valtrex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Valtrex USP).
