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DOSAGE - INJECTABLE;INJECTION - EQ 250MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20212
DOSAGE - INJECTABLE;INJECTION - EQ 500MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20212
DOSAGE - INJECTABLE;INJECTION - EQ 500MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22025
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ABOUT THIS PAGE
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PharmaCompass offers a list of Dexrazoxane 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 Dexrazoxane manufacturer or Dexrazoxane supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dexrazoxane manufacturer or Dexrazoxane supplier.
PharmaCompass also assists you with knowing the Dexrazoxane API Price utilized in the formulation of products. Dexrazoxane API Price is not always fixed or binding as the Dexrazoxane Price is obtained through a variety of data sources. The Dexrazoxane Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cardioxane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cardioxane, including repackagers and relabelers. The FDA regulates Cardioxane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cardioxane 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 Cardioxane manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cardioxane supplier is an individual or a company that provides Cardioxane active pharmaceutical ingredient (API) or Cardioxane finished formulations upon request. The Cardioxane suppliers may include Cardioxane API manufacturers, exporters, distributors and traders.
click here to find a list of Cardioxane suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cardioxane DMF (Drug Master File) is a document detailing the whole manufacturing process of Cardioxane active pharmaceutical ingredient (API) in detail. Different forms of Cardioxane DMFs exist exist since differing nations have different regulations, such as Cardioxane USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cardioxane DMF submitted to regulatory agencies in the US is known as a USDMF. Cardioxane USDMF includes data on Cardioxane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cardioxane USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cardioxane 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 Cardioxane Drug Master File in Japan (Cardioxane JDMF) empowers Cardioxane 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 Cardioxane JDMF during the approval evaluation for pharmaceutical products. At the time of Cardioxane 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 Cardioxane suppliers with JDMF on PharmaCompass.
A Cardioxane written confirmation (Cardioxane WC) is an official document issued by a regulatory agency to a Cardioxane manufacturer, verifying that the manufacturing facility of a Cardioxane active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cardioxane APIs or Cardioxane finished pharmaceutical products to another nation, regulatory agencies frequently require a Cardioxane WC (written confirmation) as part of the regulatory process.
click here to find a list of Cardioxane 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 Cardioxane as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cardioxane 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 Cardioxane 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 Cardioxane and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cardioxane NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cardioxane suppliers with NDC on PharmaCompass.
Cardioxane 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 Cardioxane 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 Cardioxane GMP manufacturer or Cardioxane GMP API supplier for your needs.
A Cardioxane CoA (Certificate of Analysis) is a formal document that attests to Cardioxane's compliance with Cardioxane specifications and serves as a tool for batch-level quality control.
Cardioxane CoA mostly includes findings from lab analyses of a specific batch. For each Cardioxane 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.
Cardioxane may be tested according to a variety of international standards, such as European Pharmacopoeia (Cardioxane EP), Cardioxane JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cardioxane USP).
