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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
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ASMF
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Drugs in Development
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Eloxatin
Dosage Form : PULVER TILL INFUSIONSVÄTSKA, LÖSNING
Dosage Strength : 5 MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Eloxatin
Dosage Form : KONCENTRAT TILL INFUSIONSVÄTSKA, LÖSNING
Dosage Strength : 5 MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Eloxatin
Dosage Form : Oxaliplatino 100Mg 20Ml 1 Units Parenteral Use
Dosage Strength : 1 bottle EV 100 mg 20 ml 5 mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Eloxatin
Dosage Form : Oxaliplatino 200Mg 40Ml 1 Units Parenteral Use
Dosage Strength : 1 bottle EV 200 mg 40 ml 5 mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Eloxatin
Dosage Form : Oxaliplatino 50Mg 10Ml 1 Units Parenteral Use
Dosage Strength : 1 bottle EV 50 mg 10 ml 5 mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Eloxatin
Dosage Form : Inf Conc
Dosage Strength : 100mg/20ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Eloxatin
Dosage Form : Inf Konz
Dosage Strength : 50mg/10ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Eloxatin
Dosage Form : Inf Conc
Dosage Strength : 200mg/40ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Oxaliplatin Zentiva
Dosage Form : Inf Conc
Dosage Strength : 100mg/20ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Oxaliplatin Zentiva
Dosage Form : Inf Conc
Dosage Strength : 50mg/10ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
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DOSAGE - INJECTABLE;INTRAVENOUS - 100MG/20ML ...DOSAGE - INJECTABLE;INTRAVENOUS - 100MG/20ML (5MG/ML)
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)
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
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Oxaliplatin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxaliplatin, including repackagers and relabelers. The FDA regulates Oxaliplatin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxaliplatin 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 Oxaliplatin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oxaliplatin supplier is an individual or a company that provides Oxaliplatin active pharmaceutical ingredient (API) or Oxaliplatin finished formulations upon request. The Oxaliplatin suppliers may include Oxaliplatin API manufacturers, exporters, distributors and traders.
click here to find a list of Oxaliplatin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oxaliplatin DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxaliplatin active pharmaceutical ingredient (API) in detail. Different forms of Oxaliplatin DMFs exist exist since differing nations have different regulations, such as Oxaliplatin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oxaliplatin DMF submitted to regulatory agencies in the US is known as a USDMF. Oxaliplatin USDMF includes data on Oxaliplatin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxaliplatin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oxaliplatin 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 Oxaliplatin Drug Master File in Japan (Oxaliplatin JDMF) empowers Oxaliplatin 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 Oxaliplatin JDMF during the approval evaluation for pharmaceutical products. At the time of Oxaliplatin 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 Oxaliplatin 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 Oxaliplatin Drug Master File in Korea (Oxaliplatin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Oxaliplatin. The MFDS reviews the Oxaliplatin KDMF as part of the drug registration process and uses the information provided in the Oxaliplatin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Oxaliplatin 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 Oxaliplatin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Oxaliplatin suppliers with KDMF on PharmaCompass.
A Oxaliplatin CEP of the European Pharmacopoeia monograph is often referred to as a Oxaliplatin Certificate of Suitability (COS). The purpose of a Oxaliplatin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Oxaliplatin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Oxaliplatin to their clients by showing that a Oxaliplatin CEP has been issued for it. The manufacturer submits a Oxaliplatin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Oxaliplatin CEP holder for the record. Additionally, the data presented in the Oxaliplatin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Oxaliplatin DMF.
A Oxaliplatin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Oxaliplatin 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 Oxaliplatin suppliers with CEP (COS) on PharmaCompass.
A Oxaliplatin written confirmation (Oxaliplatin WC) is an official document issued by a regulatory agency to a Oxaliplatin manufacturer, verifying that the manufacturing facility of a Oxaliplatin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Oxaliplatin APIs or Oxaliplatin finished pharmaceutical products to another nation, regulatory agencies frequently require a Oxaliplatin WC (written confirmation) as part of the regulatory process.
click here to find a list of Oxaliplatin 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 Oxaliplatin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Oxaliplatin 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 Oxaliplatin 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 Oxaliplatin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Oxaliplatin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Oxaliplatin suppliers with NDC on PharmaCompass.
Oxaliplatin 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 Oxaliplatin 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 Oxaliplatin GMP manufacturer or Oxaliplatin GMP API supplier for your needs.
A Oxaliplatin CoA (Certificate of Analysis) is a formal document that attests to Oxaliplatin's compliance with Oxaliplatin specifications and serves as a tool for batch-level quality control.
Oxaliplatin CoA mostly includes findings from lab analyses of a specific batch. For each Oxaliplatin 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.
Oxaliplatin may be tested according to a variety of international standards, such as European Pharmacopoeia (Oxaliplatin EP), Oxaliplatin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Oxaliplatin USP).
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