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- INJECTABLE;INJECTION - EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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