Synopsis
Synopsis
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KDMF
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VMF
DRUG PRODUCT COMPOSITIONS
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| Molecular Weight | 255.23 g/mol |
|---|---|
| Molecular Formula | C9H13N5O4 |
| XLogP3 | -1.7 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 5 |
| Exact Mass | 255.09675391 g/mol |
| Monoisotopic Mass | 255.09675391 g/mol |
| Topological Polar Surface Area | 135 A^2 |
| Heavy Atom Count | 18 |
| Formal Charge | 0 |
| Complexity | 346 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 6 | |
|---|---|
| Drug Name | Cytovene |
| PubMed Health | Ganciclovir (Injection) |
| Drug Classes | Antiviral |
| Drug Label | Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV). CYTOVENE-IV is the brand name for ganciclovir sodium for injection.CYTOVENE-IV is available as sterile lyophilized powder in strength of 500 mg per vial for intraveno... |
| Active Ingredient | Ganciclovir sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 500mg base/vial |
| Market Status | Prescription |
| Company | Roche Palo |
| 2 of 6 | |
|---|---|
| Drug Name | Ganciclovir |
| PubMed Health | Ganciclovir |
| Drug Classes | Antiviral |
| Drug Label | Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV).Ganciclovir is available as 250 mg and 500 mg capsules. Each capsule contains 250 mg or 500 mg ganciclovir, USP respectively, and inactive ingredients croscarmellose s... |
| Active Ingredient | Ganciclovir sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 500mg base/vial |
| Market Status | Prescription |
| Company | Fresenius Kabi Usa; Luitpold |
| 3 of 6 | |
|---|---|
| Drug Name | Zirgan |
| PubMed Health | Ganciclovir |
| Drug Classes | Antiviral |
| Drug Label | ZIRGAN (ganciclovir ophthalmic gel) 0.15% contains a sterile, topical antiviral for ophthalmic use. The chemical name is 9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]guanine (CAS number 82410-32-0). Ganciclovir is represented by the following structu... |
| Active Ingredient | Ganciclovir |
| Dosage Form | Gel |
| Route | Ophthalmic |
| Strength | 0.15% |
| Market Status | Prescription |
| Company | Bausch And Lomb |
| 4 of 6 | |
|---|---|
| Drug Name | Cytovene |
| PubMed Health | Ganciclovir (Injection) |
| Drug Classes | Antiviral |
| Drug Label | Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV). CYTOVENE-IV is the brand name for ganciclovir sodium for injection.CYTOVENE-IV is available as sterile lyophilized powder in strength of 500 mg per vial for intraveno... |
| Active Ingredient | Ganciclovir sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 500mg base/vial |
| Market Status | Prescription |
| Company | Roche Palo |
| 5 of 6 | |
|---|---|
| Drug Name | Ganciclovir |
| PubMed Health | Ganciclovir |
| Drug Classes | Antiviral |
| Drug Label | Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV).Ganciclovir is available as 250 mg and 500 mg capsules. Each capsule contains 250 mg or 500 mg ganciclovir, USP respectively, and inactive ingredients croscarmellose s... |
| Active Ingredient | Ganciclovir sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 500mg base/vial |
| Market Status | Prescription |
| Company | Fresenius Kabi Usa; Luitpold |
| 6 of 6 | |
|---|---|
| Drug Name | Zirgan |
| PubMed Health | Ganciclovir |
| Drug Classes | Antiviral |
| Drug Label | ZIRGAN (ganciclovir ophthalmic gel) 0.15% contains a sterile, topical antiviral for ophthalmic use. The chemical name is 9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]guanine (CAS number 82410-32-0). Ganciclovir is represented by the following structu... |
| Active Ingredient | Ganciclovir |
| Dosage Form | Gel |
| Route | Ophthalmic |
| Strength | 0.15% |
| Market Status | Prescription |
| Company | Bausch And Lomb |
API SUPPLIERS
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Drugs in Development
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Rochem International Inc
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ABOUT THIS PAGE
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PharmaCompass offers a list of Ganciclovir 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 Ganciclovir manufacturer or Ganciclovir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ganciclovir manufacturer or Ganciclovir supplier.
PharmaCompass also assists you with knowing the Ganciclovir API Price utilized in the formulation of products. Ganciclovir API Price is not always fixed or binding as the Ganciclovir Price is obtained through a variety of data sources. The Ganciclovir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cymevan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cymevan, including repackagers and relabelers. The FDA regulates Cymevan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cymevan 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 Cymevan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cymevan supplier is an individual or a company that provides Cymevan active pharmaceutical ingredient (API) or Cymevan finished formulations upon request. The Cymevan suppliers may include Cymevan API manufacturers, exporters, distributors and traders.
click here to find a list of Cymevan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cymevan DMF (Drug Master File) is a document detailing the whole manufacturing process of Cymevan active pharmaceutical ingredient (API) in detail. Different forms of Cymevan DMFs exist exist since differing nations have different regulations, such as Cymevan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cymevan DMF submitted to regulatory agencies in the US is known as a USDMF. Cymevan USDMF includes data on Cymevan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cymevan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cymevan 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 Cymevan Drug Master File in Japan (Cymevan JDMF) empowers Cymevan 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 Cymevan JDMF during the approval evaluation for pharmaceutical products. At the time of Cymevan 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 Cymevan suppliers with JDMF on PharmaCompass.
A Cymevan CEP of the European Pharmacopoeia monograph is often referred to as a Cymevan Certificate of Suitability (COS). The purpose of a Cymevan CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cymevan EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cymevan to their clients by showing that a Cymevan CEP has been issued for it. The manufacturer submits a Cymevan CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cymevan CEP holder for the record. Additionally, the data presented in the Cymevan CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cymevan DMF.
A Cymevan CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cymevan 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 Cymevan suppliers with CEP (COS) on PharmaCompass.
A Cymevan written confirmation (Cymevan WC) is an official document issued by a regulatory agency to a Cymevan manufacturer, verifying that the manufacturing facility of a Cymevan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cymevan APIs or Cymevan finished pharmaceutical products to another nation, regulatory agencies frequently require a Cymevan WC (written confirmation) as part of the regulatory process.
click here to find a list of Cymevan 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 Cymevan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cymevan 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 Cymevan 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 Cymevan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cymevan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cymevan suppliers with NDC on PharmaCompass.
Cymevan 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 Cymevan 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 Cymevan GMP manufacturer or Cymevan GMP API supplier for your needs.
A Cymevan CoA (Certificate of Analysis) is a formal document that attests to Cymevan's compliance with Cymevan specifications and serves as a tool for batch-level quality control.
Cymevan CoA mostly includes findings from lab analyses of a specific batch. For each Cymevan 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.
Cymevan may be tested according to a variety of international standards, such as European Pharmacopoeia (Cymevan EP), Cymevan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cymevan USP).
