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VMF
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Data Compilation #PharmaFlow
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API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
ASMF
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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- INJECTABLE;INTRAVENOUS - 100MG/20ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- INJECTABLE;INTRAVENOUS - 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- INJECTABLE;INTRAVENOUS - 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
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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 1,2 Diaminocyclohexane Platinum Oxalate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1,2 Diaminocyclohexane Platinum Oxalate, including repackagers and relabelers. The FDA regulates 1,2 Diaminocyclohexane Platinum Oxalate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1,2 Diaminocyclohexane Platinum Oxalate 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 1,2 Diaminocyclohexane Platinum Oxalate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 1,2 Diaminocyclohexane Platinum Oxalate supplier is an individual or a company that provides 1,2 Diaminocyclohexane Platinum Oxalate active pharmaceutical ingredient (API) or 1,2 Diaminocyclohexane Platinum Oxalate finished formulations upon request. The 1,2 Diaminocyclohexane Platinum Oxalate suppliers may include 1,2 Diaminocyclohexane Platinum Oxalate API manufacturers, exporters, distributors and traders.
click here to find a list of 1,2 Diaminocyclohexane Platinum Oxalate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 1,2 Diaminocyclohexane Platinum Oxalate DMF (Drug Master File) is a document detailing the whole manufacturing process of 1,2 Diaminocyclohexane Platinum Oxalate active pharmaceutical ingredient (API) in detail. Different forms of 1,2 Diaminocyclohexane Platinum Oxalate DMFs exist exist since differing nations have different regulations, such as 1,2 Diaminocyclohexane Platinum Oxalate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1,2 Diaminocyclohexane Platinum Oxalate DMF submitted to regulatory agencies in the US is known as a USDMF. 1,2 Diaminocyclohexane Platinum Oxalate USDMF includes data on 1,2 Diaminocyclohexane Platinum Oxalate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1,2 Diaminocyclohexane Platinum Oxalate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 1,2 Diaminocyclohexane Platinum Oxalate 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 1,2 Diaminocyclohexane Platinum Oxalate Drug Master File in Japan (1,2 Diaminocyclohexane Platinum Oxalate JDMF) empowers 1,2 Diaminocyclohexane Platinum Oxalate 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 1,2 Diaminocyclohexane Platinum Oxalate JDMF during the approval evaluation for pharmaceutical products. At the time of 1,2 Diaminocyclohexane Platinum Oxalate 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 1,2 Diaminocyclohexane Platinum Oxalate 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 1,2 Diaminocyclohexane Platinum Oxalate Drug Master File in Korea (1,2 Diaminocyclohexane Platinum Oxalate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 1,2 Diaminocyclohexane Platinum Oxalate. The MFDS reviews the 1,2 Diaminocyclohexane Platinum Oxalate KDMF as part of the drug registration process and uses the information provided in the 1,2 Diaminocyclohexane Platinum Oxalate KDMF to evaluate the safety and efficacy of the drug.
After submitting a 1,2 Diaminocyclohexane Platinum Oxalate 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 1,2 Diaminocyclohexane Platinum Oxalate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 1,2 Diaminocyclohexane Platinum Oxalate suppliers with KDMF on PharmaCompass.
A 1,2 Diaminocyclohexane Platinum Oxalate CEP of the European Pharmacopoeia monograph is often referred to as a 1,2 Diaminocyclohexane Platinum Oxalate Certificate of Suitability (COS). The purpose of a 1,2 Diaminocyclohexane Platinum Oxalate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 1,2 Diaminocyclohexane Platinum Oxalate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 1,2 Diaminocyclohexane Platinum Oxalate to their clients by showing that a 1,2 Diaminocyclohexane Platinum Oxalate CEP has been issued for it. The manufacturer submits a 1,2 Diaminocyclohexane Platinum Oxalate CEP (COS) as part of the market authorization procedure, and it takes on the role of a 1,2 Diaminocyclohexane Platinum Oxalate CEP holder for the record. Additionally, the data presented in the 1,2 Diaminocyclohexane Platinum Oxalate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 1,2 Diaminocyclohexane Platinum Oxalate DMF.
A 1,2 Diaminocyclohexane Platinum Oxalate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 1,2 Diaminocyclohexane Platinum Oxalate 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 1,2 Diaminocyclohexane Platinum Oxalate suppliers with CEP (COS) on PharmaCompass.
A 1,2 Diaminocyclohexane Platinum Oxalate written confirmation (1,2 Diaminocyclohexane Platinum Oxalate WC) is an official document issued by a regulatory agency to a 1,2 Diaminocyclohexane Platinum Oxalate manufacturer, verifying that the manufacturing facility of a 1,2 Diaminocyclohexane Platinum Oxalate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 1,2 Diaminocyclohexane Platinum Oxalate APIs or 1,2 Diaminocyclohexane Platinum Oxalate finished pharmaceutical products to another nation, regulatory agencies frequently require a 1,2 Diaminocyclohexane Platinum Oxalate WC (written confirmation) as part of the regulatory process.
click here to find a list of 1,2 Diaminocyclohexane Platinum Oxalate 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 1,2 Diaminocyclohexane Platinum Oxalate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 1,2 Diaminocyclohexane Platinum Oxalate 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 1,2 Diaminocyclohexane Platinum Oxalate 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 1,2 Diaminocyclohexane Platinum Oxalate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 1,2 Diaminocyclohexane Platinum Oxalate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 1,2 Diaminocyclohexane Platinum Oxalate suppliers with NDC on PharmaCompass.
1,2 Diaminocyclohexane Platinum Oxalate 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 1,2 Diaminocyclohexane Platinum Oxalate 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 1,2 Diaminocyclohexane Platinum Oxalate GMP manufacturer or 1,2 Diaminocyclohexane Platinum Oxalate GMP API supplier for your needs.
A 1,2 Diaminocyclohexane Platinum Oxalate CoA (Certificate of Analysis) is a formal document that attests to 1,2 Diaminocyclohexane Platinum Oxalate's compliance with 1,2 Diaminocyclohexane Platinum Oxalate specifications and serves as a tool for batch-level quality control.
1,2 Diaminocyclohexane Platinum Oxalate CoA mostly includes findings from lab analyses of a specific batch. For each 1,2 Diaminocyclohexane Platinum Oxalate 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.
1,2 Diaminocyclohexane Platinum Oxalate may be tested according to a variety of international standards, such as European Pharmacopoeia (1,2 Diaminocyclohexane Platinum Oxalate EP), 1,2 Diaminocyclohexane Platinum Oxalate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (1,2 Diaminocyclohexane Platinum Oxalate USP).
