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Molecular Weight | 390.82 g/mol |
---|---|
Molecular Formula | C14H23ClN6O5 |
Hydrogen Bond Donor Count | 5 |
Hydrogen Bond Acceptor Count | 7 |
Rotatable Bond Count | 9 |
Exact Mass | 390.1418455 g/mol |
Monoisotopic Mass | 390.1418455 g/mol |
Topological Polar Surface Area | 167 A^2 |
Heavy Atom Count | 26 |
Formal Charge | 0 |
Complexity | 528 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 1 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 4 | |
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Drug Name | Valcyte |
PubMed Health | Valganciclovir (By mouth) |
Drug Classes | Antiviral |
Drug Label | Valcyte 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 Ingredient | Valganciclovir hydrochloride |
Dosage Form | Tablet; For solution |
Route | Oral |
Strength | 50mg/ml; eq 450mg base |
Market Status | Prescription |
Company | Hoffmann La Roche |
2 of 4 | |
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Drug Name | Valganciclovir hydrochloride |
Drug Label | Valcyte 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 Ingredient | Valganciclovir hydrochloride |
Dosage Form | Tablet |
Route | oral |
Strength | 450mg |
Market Status | Tentative Approval |
Company | Ranbaxy |
3 of 4 | |
---|---|
Drug Name | Valcyte |
PubMed Health | Valganciclovir (By mouth) |
Drug Classes | Antiviral |
Drug Label | Valcyte 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 Ingredient | Valganciclovir hydrochloride |
Dosage Form | Tablet; For solution |
Route | Oral |
Strength | 50mg/ml; eq 450mg base |
Market Status | Prescription |
Company | Hoffmann La Roche |
4 of 4 | |
---|---|
Drug Name | Valganciclovir hydrochloride |
Drug Label | Valcyte 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 Ingredient | Valganciclovir hydrochloride |
Dosage Form | Tablet |
Route | oral |
Strength | 450mg |
Market Status | Tentative Approval |
Company | Ranbaxy |
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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ABOUT THIS PAGE
A Valcyte manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Valcyte, including repackagers and relabelers. The FDA regulates Valcyte manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Valcyte 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 Valcyte manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Valcyte supplier is an individual or a company that provides Valcyte active pharmaceutical ingredient (API) or Valcyte finished formulations upon request. The Valcyte suppliers may include Valcyte API manufacturers, exporters, distributors and traders.
click here to find a list of Valcyte suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Valcyte DMF (Drug Master File) is a document detailing the whole manufacturing process of Valcyte active pharmaceutical ingredient (API) in detail. Different forms of Valcyte DMFs exist exist since differing nations have different regulations, such as Valcyte USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Valcyte DMF submitted to regulatory agencies in the US is known as a USDMF. Valcyte USDMF includes data on Valcyte's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Valcyte USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Valcyte suppliers with USDMF on PharmaCompass.
A Valcyte CEP of the European Pharmacopoeia monograph is often referred to as a Valcyte Certificate of Suitability (COS). The purpose of a Valcyte CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Valcyte EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Valcyte to their clients by showing that a Valcyte CEP has been issued for it. The manufacturer submits a Valcyte CEP (COS) as part of the market authorization procedure, and it takes on the role of a Valcyte CEP holder for the record. Additionally, the data presented in the Valcyte CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Valcyte DMF.
A Valcyte CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Valcyte 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 Valcyte suppliers with CEP (COS) on PharmaCompass.
A Valcyte written confirmation (Valcyte WC) is an official document issued by a regulatory agency to a Valcyte manufacturer, verifying that the manufacturing facility of a Valcyte active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Valcyte APIs or Valcyte finished pharmaceutical products to another nation, regulatory agencies frequently require a Valcyte WC (written confirmation) as part of the regulatory process.
click here to find a list of Valcyte 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 Valcyte as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Valcyte 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 Valcyte 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 Valcyte and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Valcyte NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Valcyte suppliers with NDC on PharmaCompass.
Valcyte 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 Valcyte 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 Valcyte GMP manufacturer or Valcyte GMP API supplier for your needs.
A Valcyte CoA (Certificate of Analysis) is a formal document that attests to Valcyte's compliance with Valcyte specifications and serves as a tool for batch-level quality control.
Valcyte CoA mostly includes findings from lab analyses of a specific batch. For each Valcyte 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.
Valcyte may be tested according to a variety of international standards, such as European Pharmacopoeia (Valcyte EP), Valcyte JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Valcyte USP).
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