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API SUPPLIERS
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USDMF
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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- INJECTABLE;INTRAVENOUS - 100MG/20ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- INJECTABLE;INTRAVENOUS - 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- INJECTABLE;INTRAVENOUS - 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
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Co-Processed Excipients
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Global Sales Information
US Medicaid Prescriptions
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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 oxaliplatine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of oxaliplatine, including repackagers and relabelers. The FDA regulates oxaliplatine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. oxaliplatine 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 oxaliplatine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A oxaliplatine supplier is an individual or a company that provides oxaliplatine active pharmaceutical ingredient (API) or oxaliplatine finished formulations upon request. The oxaliplatine suppliers may include oxaliplatine API manufacturers, exporters, distributors and traders.
click here to find a list of oxaliplatine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A oxaliplatine DMF (Drug Master File) is a document detailing the whole manufacturing process of oxaliplatine active pharmaceutical ingredient (API) in detail. Different forms of oxaliplatine DMFs exist exist since differing nations have different regulations, such as oxaliplatine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A oxaliplatine DMF submitted to regulatory agencies in the US is known as a USDMF. oxaliplatine USDMF includes data on oxaliplatine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The oxaliplatine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of oxaliplatine 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 oxaliplatine Drug Master File in Japan (oxaliplatine JDMF) empowers oxaliplatine 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 oxaliplatine JDMF during the approval evaluation for pharmaceutical products. At the time of oxaliplatine 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 oxaliplatine 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 oxaliplatine Drug Master File in Korea (oxaliplatine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of oxaliplatine. The MFDS reviews the oxaliplatine KDMF as part of the drug registration process and uses the information provided in the oxaliplatine KDMF to evaluate the safety and efficacy of the drug.
After submitting a oxaliplatine 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 oxaliplatine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of oxaliplatine suppliers with KDMF on PharmaCompass.
A oxaliplatine CEP of the European Pharmacopoeia monograph is often referred to as a oxaliplatine Certificate of Suitability (COS). The purpose of a oxaliplatine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of oxaliplatine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of oxaliplatine to their clients by showing that a oxaliplatine CEP has been issued for it. The manufacturer submits a oxaliplatine CEP (COS) as part of the market authorization procedure, and it takes on the role of a oxaliplatine CEP holder for the record. Additionally, the data presented in the oxaliplatine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the oxaliplatine DMF.
A oxaliplatine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. oxaliplatine 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 oxaliplatine suppliers with CEP (COS) on PharmaCompass.
A oxaliplatine written confirmation (oxaliplatine WC) is an official document issued by a regulatory agency to a oxaliplatine manufacturer, verifying that the manufacturing facility of a oxaliplatine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting oxaliplatine APIs or oxaliplatine finished pharmaceutical products to another nation, regulatory agencies frequently require a oxaliplatine WC (written confirmation) as part of the regulatory process.
click here to find a list of oxaliplatine 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 oxaliplatine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for oxaliplatine 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 oxaliplatine 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 oxaliplatine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a oxaliplatine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of oxaliplatine suppliers with NDC on PharmaCompass.
oxaliplatine 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 oxaliplatine 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 oxaliplatine GMP manufacturer or oxaliplatine GMP API supplier for your needs.
A oxaliplatine CoA (Certificate of Analysis) is a formal document that attests to oxaliplatine's compliance with oxaliplatine specifications and serves as a tool for batch-level quality control.
oxaliplatine CoA mostly includes findings from lab analyses of a specific batch. For each oxaliplatine 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.
oxaliplatine may be tested according to a variety of international standards, such as European Pharmacopoeia (oxaliplatine EP), oxaliplatine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (oxaliplatine USP).
