Synopsis
Synopsis
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JDMF
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KDMF
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VMF
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Australia
DRUG PRODUCT COMPOSITIONS
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US Patents
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US Exclusivities
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Health Canada Patents
Annual Reports
NA
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
Molecular Weight | 182.18 g/mol |
---|---|
Molecular Formula | C6H10N6O |
XLogP3 | -0.3 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 4 |
Rotatable Bond Count | 3 |
Exact Mass | 182.09160896 g/mol |
Monoisotopic Mass | 182.09160896 g/mol |
Topological Polar Surface Area | 95.4 A^2 |
Heavy Atom Count | 13 |
Formal Charge | 0 |
Complexity | 302 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 1 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 4 | |
---|---|
Drug Name | Dacarbazine |
PubMed Health | Dacarbazine (Injection) |
Drug Classes | Antineoplastic Agent |
Drug Label | Dacarbazine for injection, USP is a colorless to an ivory colored solid which is light sensitive. Each 20 mL vial contains 200 mg of dacarbazine (active ingredient). Each vial also contains anhydrous citric acid and mannitol. Dacarbazine for injectio... |
Active Ingredient | Dacarbazine |
Dosage Form | Injectable |
Route | Injection |
Strength | 500mg/vial; 100mg/vial; 200mg/vial |
Market Status | Prescription |
Company | Fresenius Kabi Usa; Hospira; Teva Pharms Usa; Eurohlth Intl |
2 of 4 | |
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Drug Name | Dtic-dome |
Active Ingredient | Dacarbazine |
Dosage Form | Injectable |
Route | Injection |
Strength | 100mg/vial; 200mg/vial |
Market Status | Prescription |
Company | Bayer Hlthcare |
3 of 4 | |
---|---|
Drug Name | Dacarbazine |
PubMed Health | Dacarbazine (Injection) |
Drug Classes | Antineoplastic Agent |
Drug Label | Dacarbazine for injection, USP is a colorless to an ivory colored solid which is light sensitive. Each 20 mL vial contains 200 mg of dacarbazine (active ingredient). Each vial also contains anhydrous citric acid and mannitol. Dacarbazine for injectio... |
Active Ingredient | Dacarbazine |
Dosage Form | Injectable |
Route | Injection |
Strength | 500mg/vial; 100mg/vial; 200mg/vial |
Market Status | Prescription |
Company | Fresenius Kabi Usa; Hospira; Teva Pharms Usa; Eurohlth Intl |
4 of 4 | |
---|---|
Drug Name | Dtic-dome |
Active Ingredient | Dacarbazine |
Dosage Form | Injectable |
Route | Injection |
Strength | 100mg/vial; 200mg/vial |
Market Status | Prescription |
Company | Bayer Hlthcare |
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PharmaCompass offers a list of Dacarbazine 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 Dacarbazine manufacturer or Dacarbazine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dacarbazine manufacturer or Dacarbazine supplier.
PharmaCompass also assists you with knowing the Dacarbazine API Price utilized in the formulation of products. Dacarbazine API Price is not always fixed or binding as the Dacarbazine Price is obtained through a variety of data sources. The Dacarbazine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A DTIC Dome manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DTIC Dome, including repackagers and relabelers. The FDA regulates DTIC Dome manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DTIC Dome 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 DTIC Dome manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A DTIC Dome supplier is an individual or a company that provides DTIC Dome active pharmaceutical ingredient (API) or DTIC Dome finished formulations upon request. The DTIC Dome suppliers may include DTIC Dome API manufacturers, exporters, distributors and traders.
click here to find a list of DTIC Dome suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DTIC Dome DMF (Drug Master File) is a document detailing the whole manufacturing process of DTIC Dome active pharmaceutical ingredient (API) in detail. Different forms of DTIC Dome DMFs exist exist since differing nations have different regulations, such as DTIC Dome USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DTIC Dome DMF submitted to regulatory agencies in the US is known as a USDMF. DTIC Dome USDMF includes data on DTIC Dome's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DTIC Dome USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DTIC Dome suppliers with USDMF on PharmaCompass.
A DTIC Dome CEP of the European Pharmacopoeia monograph is often referred to as a DTIC Dome Certificate of Suitability (COS). The purpose of a DTIC Dome CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of DTIC Dome EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of DTIC Dome to their clients by showing that a DTIC Dome CEP has been issued for it. The manufacturer submits a DTIC Dome CEP (COS) as part of the market authorization procedure, and it takes on the role of a DTIC Dome CEP holder for the record. Additionally, the data presented in the DTIC Dome CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the DTIC Dome DMF.
A DTIC Dome CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. DTIC Dome 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 DTIC Dome suppliers with CEP (COS) on PharmaCompass.
A DTIC Dome written confirmation (DTIC Dome WC) is an official document issued by a regulatory agency to a DTIC Dome manufacturer, verifying that the manufacturing facility of a DTIC Dome active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting DTIC Dome APIs or DTIC Dome finished pharmaceutical products to another nation, regulatory agencies frequently require a DTIC Dome WC (written confirmation) as part of the regulatory process.
click here to find a list of DTIC Dome 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 DTIC Dome as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for DTIC Dome 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 DTIC Dome 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 DTIC Dome and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a DTIC Dome NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of DTIC Dome suppliers with NDC on PharmaCompass.
DTIC Dome 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 DTIC Dome 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 DTIC Dome GMP manufacturer or DTIC Dome GMP API supplier for your needs.
A DTIC Dome CoA (Certificate of Analysis) is a formal document that attests to DTIC Dome's compliance with DTIC Dome specifications and serves as a tool for batch-level quality control.
DTIC Dome CoA mostly includes findings from lab analyses of a specific batch. For each DTIC Dome 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.
DTIC Dome may be tested according to a variety of international standards, such as European Pharmacopoeia (DTIC Dome EP), DTIC Dome JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DTIC Dome USP).