Synopsis
0
CEP/COS
0
KDMF
0
VMF
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATES SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - INJECTABLE;INJECTION - EQ 250MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 250MG BASE/VIAL
USFDA APPLICATION NUMBER - 20212
DOSAGE - INJECTABLE;INJECTION - EQ 500MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 500MG BASE/VIAL
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- INJECTABLE;INJECTION - EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Related Excipient Companies
Digital Content
NEWS #PharmaBuzz
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Dexrazoxane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dexrazoxane, including repackagers and relabelers. The FDA regulates Dexrazoxane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dexrazoxane 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 Dexrazoxane manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dexrazoxane supplier is an individual or a company that provides Dexrazoxane active pharmaceutical ingredient (API) or Dexrazoxane finished formulations upon request. The Dexrazoxane suppliers may include Dexrazoxane API manufacturers, exporters, distributors and traders.
click here to find a list of Dexrazoxane suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dexrazoxane DMF (Drug Master File) is a document detailing the whole manufacturing process of Dexrazoxane active pharmaceutical ingredient (API) in detail. Different forms of Dexrazoxane DMFs exist exist since differing nations have different regulations, such as Dexrazoxane USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dexrazoxane DMF submitted to regulatory agencies in the US is known as a USDMF. Dexrazoxane USDMF includes data on Dexrazoxane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dexrazoxane USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dexrazoxane 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 Dexrazoxane Drug Master File in Japan (Dexrazoxane JDMF) empowers Dexrazoxane 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 Dexrazoxane JDMF during the approval evaluation for pharmaceutical products. At the time of Dexrazoxane 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 Dexrazoxane suppliers with JDMF on PharmaCompass.
A Dexrazoxane written confirmation (Dexrazoxane WC) is an official document issued by a regulatory agency to a Dexrazoxane manufacturer, verifying that the manufacturing facility of a Dexrazoxane active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dexrazoxane APIs or Dexrazoxane finished pharmaceutical products to another nation, regulatory agencies frequently require a Dexrazoxane WC (written confirmation) as part of the regulatory process.
click here to find a list of Dexrazoxane 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 Dexrazoxane as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dexrazoxane 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 Dexrazoxane 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 Dexrazoxane and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dexrazoxane NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dexrazoxane suppliers with NDC on PharmaCompass.
Dexrazoxane 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 Dexrazoxane 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 Dexrazoxane GMP manufacturer or Dexrazoxane GMP API supplier for your needs.
A Dexrazoxane CoA (Certificate of Analysis) is a formal document that attests to Dexrazoxane's compliance with Dexrazoxane specifications and serves as a tool for batch-level quality control.
Dexrazoxane CoA mostly includes findings from lab analyses of a specific batch. For each Dexrazoxane 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.
Dexrazoxane may be tested according to a variety of international standards, such as European Pharmacopoeia (Dexrazoxane EP), Dexrazoxane JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dexrazoxane USP).
LOOKING FOR A SUPPLIER?
