Synopsis
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CEP/COS
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JDMF
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KDMF
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VMF
DRUG PRODUCT COMPOSITIONS
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23496
Submission : 2010-01-29
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-17
Pay. Date : 2014-03-20
DMF Number : 27895
Submission : 2014-02-18
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-02
Pay. Date : 2014-03-19
DMF Number : 28101
Submission : 2014-04-01
Status :
Type : II
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
Lead Product(s) : Cabazitaxel
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Natco Pharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Natco Pharma's Partner Breckenridge Gets FDA Nod for Prostate Cancer Drug
Details : Cabazitaxel intravenous powder of strength 60mg/1.5ml (40mg/ml), is an antineoplastic agent and a microtubule inhibitor used in the treatment of prostate cancer.
Product Name : Cabazitaxel-Generic
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
July 25, 2022
Lead Product(s) : Cabazitaxel
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Natco Pharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Cabazitaxel Intravenous Powder (generic for Jevtana Kit®), is a Microtubule inhibitor, available in the 60mg/1.5mL (40mg/mL) strength used fo the treatment of Prostate cancer.
Product Name : Cabazitaxel-Generic
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
January 08, 2022
Lead Product(s) : Cabazitaxel,Prednisone
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
EVER Pharma gains EU marketing authorization for value-added Cabazitaxel
Details : Cabazitaxel EVER Pharma in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic castration resistant prostate cancer.
Product Name : Cabazitaxel EVER Pharma
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
October 21, 2020
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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 : JEVTANA
Dosage Form : CONCENTRATE AND SOLVENT FOR
Dosage Strength : 60 MG
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 : Jevtana
Dosage Form : Cabazitaxel 60Mg 1 Unit Parenteral Use
Dosage Strength : 1 vial EV 60 mg 1.5 ml + 1 vial solv 4.5 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 : Norway
Brand Name : Jevtana
Dosage Form : Concentrate and liquid to the infusion fluid, resolution
Dosage Strength : 60 mg
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Jevtana
Dosage Form : Inf Konz
Dosage Strength : 60mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 40MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Approved...
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 60MG/1.5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Approved...
Registration Country : India
NanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.
Regulatory Info :
Registration Country : Iran
Brand Name : Cabotax
Dosage Form : Vial
Dosage Strength : 60MG/1.5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Ever Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.
Regulatory Info :
Registration Country : Austria
Brand Name :
Dosage Form : Concentrate for Soluti...
Dosage Strength : 10MG/1ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Austria
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DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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APIs
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US Patents
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Patent Expiration Date : 2030-10-27
US Patent Number : 10716777
Drug Substance Claim :
Drug Product Claim :
Application Number : 201023
Patent Use Code : U-2856
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2030-10-27
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Patent Expiration Date : 2030-10-27
US Patent Number : 8927592
Drug Substance Claim :
Drug Product Claim :
Application Number : 201023
Patent Use Code : U-3200
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2030-10-27
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Patent Expiration Date : 2025-12-10
US Patent Number : 7241907
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 201023
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2025-12-10
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Patent Expiration Date : 2031-04-27
US Patent Number : 8927592*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 201023
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2031-04-27
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Patent Expiration Date : 2026-06-10
US Patent Number : 7241907*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 201023
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2026-06-10
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Patent Expiration Date : 2030-10-27
US Patent Number : 10583110
Drug Substance Claim :
Drug Product Claim :
Application Number : 201023
Patent Use Code : U-2753
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2030-10-27
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Health Canada Patents
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Patent Expiration Date : 2016-03-25
Date Granted : 2004-02-17
Brand Name : JEVTANA
Patent Number : 2214319
Filing Date : 1996-03-25
Strength per Unit : 40 mg / mL
Dosage Form : Solution
Human Or VET : Human
Route of Administration : Intravenous
Patent Expiration Date : 2016-03-25
Date Granted : 2004-02-17
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
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PharmaCompass offers a list of Cabazitaxel 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 Cabazitaxel manufacturer or Cabazitaxel supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cabazitaxel manufacturer or Cabazitaxel supplier.
PharmaCompass also assists you with knowing the Cabazitaxel API Price utilized in the formulation of products. Cabazitaxel API Price is not always fixed or binding as the Cabazitaxel Price is obtained through a variety of data sources. The Cabazitaxel Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cabazitaxel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cabazitaxel, including repackagers and relabelers. The FDA regulates Cabazitaxel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cabazitaxel 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 Cabazitaxel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cabazitaxel supplier is an individual or a company that provides Cabazitaxel active pharmaceutical ingredient (API) or Cabazitaxel finished formulations upon request. The Cabazitaxel suppliers may include Cabazitaxel API manufacturers, exporters, distributors and traders.
click here to find a list of Cabazitaxel suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cabazitaxel DMF (Drug Master File) is a document detailing the whole manufacturing process of Cabazitaxel active pharmaceutical ingredient (API) in detail. Different forms of Cabazitaxel DMFs exist exist since differing nations have different regulations, such as Cabazitaxel USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cabazitaxel DMF submitted to regulatory agencies in the US is known as a USDMF. Cabazitaxel USDMF includes data on Cabazitaxel's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cabazitaxel USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cabazitaxel suppliers with USDMF on PharmaCompass.
A Cabazitaxel written confirmation (Cabazitaxel WC) is an official document issued by a regulatory agency to a Cabazitaxel manufacturer, verifying that the manufacturing facility of a Cabazitaxel active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cabazitaxel APIs or Cabazitaxel finished pharmaceutical products to another nation, regulatory agencies frequently require a Cabazitaxel WC (written confirmation) as part of the regulatory process.
click here to find a list of Cabazitaxel 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 Cabazitaxel as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cabazitaxel 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 Cabazitaxel 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 Cabazitaxel and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cabazitaxel NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cabazitaxel suppliers with NDC on PharmaCompass.
Cabazitaxel 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 Cabazitaxel 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 Cabazitaxel GMP manufacturer or Cabazitaxel GMP API supplier for your needs.
A Cabazitaxel CoA (Certificate of Analysis) is a formal document that attests to Cabazitaxel's compliance with Cabazitaxel specifications and serves as a tool for batch-level quality control.
Cabazitaxel CoA mostly includes findings from lab analyses of a specific batch. For each Cabazitaxel 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.
Cabazitaxel may be tested according to a variety of international standards, such as European Pharmacopoeia (Cabazitaxel EP), Cabazitaxel JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cabazitaxel USP).
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