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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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API Imports and Exports
Drugs in Development
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DOSAGE - INJECTABLE;INTRAVENOUS - 100MG/20ML ...DOSAGE - INJECTABLE;INTRAVENOUS - 100MG/20ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21759
DOSAGE - INJECTABLE;INTRAVENOUS - 200MG/40ML ...DOSAGE - INJECTABLE;INTRAVENOUS - 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21759
DOSAGE - INJECTABLE;INTRAVENOUS - 50MG/10ML (...DOSAGE - INJECTABLE;INTRAVENOUS - 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21759
DOSAGE - INJECTABLE;INTRAVENOUS - 100MG/20ML ...DOSAGE - INJECTABLE;INTRAVENOUS - 100MG/20ML (5MG/ML)
USFDA APPLICATION NUMBER - 22160
DOSAGE - INJECTABLE;INTRAVENOUS - 50MG/10ML (...DOSAGE - INJECTABLE;INTRAVENOUS - 50MG/10ML (5MG/ML)
USFDA APPLICATION NUMBER - 22160
Related Excipient Companies
SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
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Granulation
Direct Compression
Solubilizers
Co-Processed Excipients
Parenteral
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Oxaliplatin 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 Oxaliplatin manufacturer or Oxaliplatin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Oxaliplatin manufacturer or Oxaliplatin supplier.
PharmaCompass also assists you with knowing the Oxaliplatin API Price utilized in the formulation of products. Oxaliplatin API Price is not always fixed or binding as the Oxaliplatin Price is obtained through a variety of data sources. The Oxaliplatin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Eloxatine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eloxatine, including repackagers and relabelers. The FDA regulates Eloxatine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eloxatine 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 Eloxatine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eloxatine supplier is an individual or a company that provides Eloxatine active pharmaceutical ingredient (API) or Eloxatine finished formulations upon request. The Eloxatine suppliers may include Eloxatine API manufacturers, exporters, distributors and traders.
click here to find a list of Eloxatine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eloxatine DMF (Drug Master File) is a document detailing the whole manufacturing process of Eloxatine active pharmaceutical ingredient (API) in detail. Different forms of Eloxatine DMFs exist exist since differing nations have different regulations, such as Eloxatine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eloxatine DMF submitted to regulatory agencies in the US is known as a USDMF. Eloxatine USDMF includes data on Eloxatine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eloxatine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eloxatine 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 Eloxatine Drug Master File in Japan (Eloxatine JDMF) empowers Eloxatine 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 Eloxatine JDMF during the approval evaluation for pharmaceutical products. At the time of Eloxatine 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 Eloxatine suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Eloxatine Drug Master File in Korea (Eloxatine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eloxatine. The MFDS reviews the Eloxatine KDMF as part of the drug registration process and uses the information provided in the Eloxatine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Eloxatine KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Eloxatine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Eloxatine suppliers with KDMF on PharmaCompass.
A Eloxatine CEP of the European Pharmacopoeia monograph is often referred to as a Eloxatine Certificate of Suitability (COS). The purpose of a Eloxatine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Eloxatine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Eloxatine to their clients by showing that a Eloxatine CEP has been issued for it. The manufacturer submits a Eloxatine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Eloxatine CEP holder for the record. Additionally, the data presented in the Eloxatine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Eloxatine DMF.
A Eloxatine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Eloxatine 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 Eloxatine suppliers with CEP (COS) on PharmaCompass.
A Eloxatine written confirmation (Eloxatine WC) is an official document issued by a regulatory agency to a Eloxatine manufacturer, verifying that the manufacturing facility of a Eloxatine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Eloxatine APIs or Eloxatine finished pharmaceutical products to another nation, regulatory agencies frequently require a Eloxatine WC (written confirmation) as part of the regulatory process.
click here to find a list of Eloxatine 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 Eloxatine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Eloxatine 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 Eloxatine 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 Eloxatine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Eloxatine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Eloxatine suppliers with NDC on PharmaCompass.
Eloxatine 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 Eloxatine 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 Eloxatine GMP manufacturer or Eloxatine GMP API supplier for your needs.
A Eloxatine CoA (Certificate of Analysis) is a formal document that attests to Eloxatine's compliance with Eloxatine specifications and serves as a tool for batch-level quality control.
Eloxatine CoA mostly includes findings from lab analyses of a specific batch. For each Eloxatine 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.
Eloxatine may be tested according to a variety of international standards, such as European Pharmacopoeia (Eloxatine EP), Eloxatine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eloxatine USP).
