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1. Jevtana
2. Kabazitaxel
1. 183133-96-2
2. Jevtana
3. Taxoid Xrp6258
4. Txd 258
5. Xrp-6258
6. Cabazitaxelum
7. Xrp6258
8. Xrp 6258
9. Jevtana (tn)
10. Nsc-761432
11. Chebi:63584
12. Txd-258
13. 51f690397j
14. Kabazitaxel
15. Jevtana Kit
16. Cabazitaxel (jevtana)
17. (2ar,4s,4as,6r,9s,11s,12s,12ar,12bs)-12b-acetoxy-9-(((2r,3s)-3-((tert-butoxycarbonyl)amino)-2-hydroxy-3-phenylpropanoyl)oxy)-11-hydroxy-4,6-dimethoxy-4a,8,13,13-tetramethyl-5-oxo-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-1h-7,11-methanocyclodeca[3,4]benzo[1,2-b]oxet-12-yl Benzoate.
18. Cabazitaxel Acetonate
19. Cabazitaxel Acetonate [jan]
20. Cabazitaxel Injection
21. Cabazitaxel [usan:inn]
22. Jevanta
23. Txd258
24. Unii-51f690397j
25. Rpr 116258a
26. Rpr-116258a
27. Cabazitaxel [mi]
28. Cabazitaxel [inn]
29. Cabazitaxel (usan/inn)
30. Cabazitaxel [usan]
31. Cabazitaxel [vandf]
32. Cabazitaxel [mart.]
33. Cabazitaxel [who-dd]
34. Schembl179674
35. Cabazitaxel [ema Epar]
36. Gtpl6798
37. Chembl1201748
38. Amy4317
39. Cabazitaxel [orange Book]
40. Dtxsid40171389
41. Ex-a838
42. Mfcd18827611
43. Nsc761432
44. Nsc794609
45. S3022
46. Zinc85536932
47. Akos032947285
48. Ccg-270519
49. Cs-0972
50. Db06772
51. Nsc 761432
52. Nsc-794609
53. Ncgc00346704-01
54. Ncgc00346704-03
55. As-75355
56. Hy-15459
57. A25044
58. D09755
59. Ab01273971-01
60. Ab01273971_02
61. Q412963
62. Sr-01000941585
63. J-011721
64. J-519981
65. Sr-01000941585-1
66. (((tertbutoxy)carbonyl)amino)-2-hydroxy-3-phenylpropanoate1-hydroxy-7beta,10beta-dimethoxy-9-oxo-5beta,20-epoxytax-11-ene-2alpha,4,13alpha-triyl 4-acetate 2-benzoate 13-((2r,3s)-3-
67. (1s)-5beta,20-epoxy-9-oxo-7beta,10beta-dimethoxytaxa-11-ene-1,2alpha,4alpha,13alpha-tetraol 2-benzoate 4-acetate 13-[(2r,3s)-2-hydroxy-3-(tert-butoxycarbonylamino)-3-phenylpropionate]
68. (1s,2s,3r,4s,7r,9s,10s,12r,15s)-4-(acetyloxy)-15-{[(2r,3s)-3-{[(tert-butoxy)carbonyl]amino}-2-hydroxy-3-phenylpropanoyl]oxy}-1-hydroxy-9,12-dimethoxy-10,14,17,17-tetramethyl-11-oxo-6-oxatetracyclo[11.3.1.0(3),(1)?.0?,?]heptadec-13-en-2-yl Benzoate
69. (1s,2s,3r,4s,7r,9s,10s,12r,15s)-4-(acetyloxy)-15-{[(2r,3s)-3-{[(tert-butoxy)carbonyl]amino}-2-hydroxy-3-phenylpropanoyl]oxy}-1-hydroxy-9,12-dimethoxy-10,14,17,17-tetramethyl-11-oxo-6-oxatetracyclo[11.3.1.0^{3,10}.0^{4,7}]heptadec-13-en-2-yl Benzoate
70. (2alpha,5beta,7beta,10beta,13alpha)-4-acetoxy-13-({(2r,3s)-3-[(tert-butoxycarbonyl)amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1-hydroxy-7,10-dimethoxy-9-oxo-5,20-epoxytax-11-en-2-yl Benzoate
71. (2ar,4s,4as,6r,9s,11s,12s,12ar,12bs)-12b-acetoxy-9-(((2r,3s)-3-((tert-butoxycarbonyl)amino)-2-hydroxy-3-phenylpropanoyl)oxy)-11-hydroxy-4,6-dimethoxy-4a,8,13,1
72. (2ar,4s,4as,6r,9s,11s,12s,12ar,12bs)-12b-acetoxy-9-(((2r,3s)-3-((tert-butoxycarbonyl)amino)-2-hydroxy-3-phenylpropanoyl)oxy)-11-hydroxy-4,6-dimethoxy-4a,8,13,13-tetramethyl-5-oxo-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-1h-7,11-methanocyclodeca[3,4]benzo[1,2-b]oxet-12-yl Benzoate
73. [(1s,2s,3r,4s,7r,9s,10s,12r,15s)-4-acetyloxy-1-hydroxy-15-[(2r,3s)-2-hydroxy-3-[(2-methylpropan-2-yl)oxycarbonylamino]-3-phenylpropanoyl]oxy-9,12-dimethoxy-10,14,17,17-tetramethyl-11-oxo-6-oxatetracyclo[11.3.1.03,10.04,7]heptadec-13-en-2-yl] Benzoate
74. 1-hydroxy-7,10-dimethoxy-9-oxo-5,20-epoxytax-11-ene-2,4,13-triyl 4-acetate 2-benzoate 13-((2r,3s)-3-(((tertbutoxy)carbonyl)amino)-2-hydroxy-3-phenylpropanoate)
75. 1-hydroxy-7.beta.,10.beta.-dimethoxy-9-oxo-5.beta.,20-epoxytax-11-ene-2.alpha.,4,13.alpha.-triyl 4-acetate 2-benzoate 13-((2r,3s)-3-(((tert-butoxy)carbonyl)amino)-2-hydroxy-3-phenylpropanoate)
76. Benzenepropanoic Acid, Beta-[[(1,1-dimethylethoxy)carbonyl]amino]-alpha-hydroxy-, (2ar,4s,4as,6r,9s,11s,12s,12ar,12bs)-12b-(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-11-hydroxy-4,6-dimethoxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1h-cyclodeca[3,4]benz[1,2-b]oxet-9-yl Ester, (alphar,betas)-
Molecular Weight | 835.9 g/mol |
---|---|
Molecular Formula | C45H57NO14 |
XLogP3 | 2.7 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 14 |
Rotatable Bond Count | 15 |
Exact Mass | 835.37790549 g/mol |
Monoisotopic Mass | 835.37790549 g/mol |
Topological Polar Surface Area | 202 Ų |
Heavy Atom Count | 60 |
Formal Charge | 0 |
Complexity | 1690 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 11 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 2 | |
---|---|
Drug Name | Jevtana kit |
Active Ingredient | Cabazitaxel |
Dosage Form | Solution |
Route | Iv (infusion) |
Strength | 60mg/1.5ml (40mg/ml) |
Market Status | Prescription |
Company | Sanofi Aventis Us |
2 of 2 | |
---|---|
Drug Name | Jevtana kit |
Active Ingredient | Cabazitaxel |
Dosage Form | Solution |
Route | Iv (infusion) |
Strength | 60mg/1.5ml (40mg/ml) |
Market Status | Prescription |
Company | Sanofi Aventis Us |
For treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen.
FDA Label
Jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.
Treatment of prostate cancer
Treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.
Cabaitaxel has anti-tumour properties and is effective against docetaxel-sensitive and -insensitive tumours.
L01CD
L01CD04
L01CD04
L - Antineoplastic and immunomodulating agents
L01 - Antineoplastic agents
L01C - Plant alkaloids and other natural products
L01CD - Taxanes
L01CD04 - Cabazitaxel
Absorption
After an intravenous dose of cabazitaxel 25 mg/m2 every three weeks to a population of 170 patients with solid tumors, the mean Cmax in patients with metastatic prostate cancer was 226 ng/mL (CV 107%) and was reached at the end of the one-hour infusion (Tmax). The mean AUC in patients with metastatic prostate cancer was 991 ng.h/mL (CV 34%). Administration with prednisone or prednisolone do not effect the pharmacokinetic profile of cabazitaxel.
Route of Elimination
After a one-hour intravenous infusion [14C]-cabazitaxel 25 mg/m2, approximately 80% of the administered dose was eliminated within 2 weeks. Cabazitaxel is mainly excreted in the feces as numerous metabolites (76% of the dose); while renal excretion of cabazitaxel and metabolites account for 3.7% of the dose (2.3% as unchanged drug in urine).
Volume of Distribution
The volume of distribution (Vss) was 4,864 L (2,643 L/m2 for a patient with a median BSA of 1.84 m2) at steady state. Compared to other taxanes, penetrates the CNS to a greater extent.
Clearance
Cabazitaxel has a plasma clearance of 48.5 L/h (CV 39%; 26.4 L/h/m2 for a patient with a median BSA of 1.84 m2) in patients with metastatic prostate cancer.
Cabazitaxel is extensively metabolized in the liver (>95%), mainly by the CYP3A4/5 isoenzyme (80% to 90%), and to a lesser extent by CYP2C8 which results in 20 different metabolites. Two of these metabolites are active demethylated derivatives of cabaxitaxel and referred to as RPR112698 and RPR123142 respectively. Docetaxel is another metabolite of cabazitaxel. Cabazitaxel is the main circulating moiety in human plasma.
Following a one-hour intravenous infusion, plasma concentrations of cabazitaxel can be described by a three-compartment pharmacokinetic model with -, -, and - half-lives of 4 minutes, 2 hours, and 95 hours, respectively.
Cabazitaxel is a microtubule inhibitor. Cabazitaxel binds to tubulin and promotes its assembly into microtubules while simultaneously inhibiting disassembly. This leads to the stabilization of microtubules, which results in the interference of mitotic and interphase cellular functions. The cell is then unable to progress further into the cell cycle, being stalled at metaphase, thus triggering apoptosis of the cancer cell.
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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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.
Lead Product(s): Cabazitaxel
Therapeutic Area: Oncology Brand Name: Cabazitaxel-Generic
Study Phase: Approved FDFProduct Type: Cytotoxic Drug
Sponsor: Natco Pharma
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 01, 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
August 01, 2022
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.
Lead Product(s): Cabazitaxel
Therapeutic Area: Oncology Brand Name: Cabazitaxel-Generic
Study Phase: Approved FDFProduct Type: Cytotoxic Drug
Sponsor: Natco Pharma
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: 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
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
Details:
Cabazitaxel EVER Pharma in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic castration resistant prostate cancer.
Lead Product(s): Cabazitaxel,Prednisone
Therapeutic Area: Oncology Brand Name: Cabazitaxel EVER Pharma
Study Phase: Approved FDFProduct Type: Cytotoxic Drug
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 21, 2020
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
Details:
The net proceeds will be used to fund the development of XmAb20717 (vudalimab), a bispecific antibody. It is being evaluated for the treatment of Metastatic Castration-resistant Prostate Cancer.
Lead Product(s): Vudalimab,Carboplatin,Cabazitaxel
Therapeutic Area: Oncology Brand Name: XmAb20717
Study Phase: Phase IIProduct Type: Large molecule
Sponsor: Leerink Partners
Deal Size: $201.3 million Upfront Cash: Undisclosed
Deal Type: Public Offering September 12, 2024
Lead Product(s) : Vudalimab,Carboplatin,Cabazitaxel
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Leerink Partners
Deal Size : $201.3 million
Deal Type : Public Offering
Xencor Closes Public Offering with Full Exercise of Underwriters' Option
Details : The net proceeds will be used to fund the development of XmAb20717 (vudalimab), a bispecific antibody. It is being evaluated for the treatment of Metastatic Castration-resistant Prostate Cancer.
Product Name : XmAb20717
Product Type : Large molecule
Upfront Cash : Undisclosed
September 12, 2024
Details:
The net proceeds will be used to fund the development of XmAb20717 (vudalimab), a bispecific antibody. It is being evaluated for the treatment of Metastatic Castration-resistant Prostate Cancer.
Lead Product(s): Vudalimab,Carboplatin,Cabazitaxel
Therapeutic Area: Oncology Brand Name: XmAb20717
Study Phase: Phase IIProduct Type: Large molecule
Sponsor: Leerink Partners
Deal Size: $175.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering September 11, 2024
Lead Product(s) : Vudalimab,Carboplatin,Cabazitaxel
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Leerink Partners
Deal Size : $175.0 million
Deal Type : Public Offering
Xencor Announces Pricing of $175 Million Public Offering of Common Stock
Details : The net proceeds will be used to fund the development of XmAb20717 (vudalimab), a bispecific antibody. It is being evaluated for the treatment of Metastatic Castration-resistant Prostate Cancer.
Product Name : XmAb20717
Product Type : Large molecule
Upfront Cash : Undisclosed
September 11, 2024
Details:
The net proceeds will be used to fund the development of XmAb20717 (vudalimab), a bispecific antibody. It is being evaluated for the treatment of Metastatic Castration-resistant Prostate Cancer.
Lead Product(s): Vudalimab,Carboplatin,Cabazitaxel
Therapeutic Area: Oncology Brand Name: XmAb20717
Study Phase: Phase IIProduct Type: Large molecule
Sponsor: Leerink Partners
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering September 10, 2024
Lead Product(s) : Vudalimab,Carboplatin,Cabazitaxel
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Leerink Partners
Deal Size : Undisclosed
Deal Type : Public Offering
Xencor Announces Proposed Public Offering of Common Stock
Details : The net proceeds will be used to fund the development of XmAb20717 (vudalimab), a bispecific antibody. It is being evaluated for the treatment of Metastatic Castration-resistant Prostate Cancer.
Product Name : XmAb20717
Product Type : Large molecule
Upfront Cash : Undisclosed
September 10, 2024
Details:
The positive interim results are particularly significant given all patients in this cohort had late-stage prostate cancer and had failed multiple anti-cancer treatments (including taxanes), in addition to surgeries and radiation, prior to entering the DEP® cabazitaxel trial.
Lead Product(s): Cabazitaxel
Therapeutic Area: Oncology Brand Name: DEP Cabazitaxel
Study Phase: Phase IIProduct Type: Cytotoxic Drug
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 27, 2021
Lead Product(s) : Cabazitaxel
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Starpharma Releases Positive DEP® phase 2 Interim Results in Prostate Cancer
Details : The positive interim results are particularly significant given all patients in this cohort had late-stage prostate cancer and had failed multiple anti-cancer treatments (including taxanes), in addition to surgeries and radiation, prior to entering the D...
Product Name : DEP Cabazitaxel
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
November 27, 2021
Details:
The composition of matter patent covers a DEP® dendrimer conjugated to multiple cabazitaxel drug molecules via a particular releasable linker. DEP® cabazitaxel is a proprietary nanoparticle version of leading prostate cancer drug cabazitaxel (Jevtana®).
Lead Product(s): Cabazitaxel
Therapeutic Area: Oncology Brand Name: DEP Cabazitaxel
Study Phase: Phase I/ Phase IIProduct Type: Cytotoxic Drug
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 15, 2021
Lead Product(s) : Cabazitaxel
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
US Patent Issued For DEP® Cabazitaxel Nanoparticle
Details : The composition of matter patent covers a DEP® dendrimer conjugated to multiple cabazitaxel drug molecules via a particular releasable linker. DEP® cabazitaxel is a proprietary nanoparticle version of leading prostate cancer drug cabazitaxel (Jevtana®...
Product Name : DEP Cabazitaxel
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
September 15, 2021
Global Sales Information
Main Therapeutic Indication : Oncology
Currency : USD
2019 Revenue in Millions : 528
2018 Revenue in Millions : 460
Growth (%) : 15
Main Therapeutic Indication : Oncology
Currency : USD
2020 Revenue in Millions : 648
2019 Revenue in Millions : 585
Growth (%) : 11
Main Therapeutic Indication : Oncology
Currency : USD
2021 Revenue in Millions : 501
2020 Revenue in Millions : 584
Growth (%) : -15
Main Therapeutic Indication : Oncology
Currency : USD
2014 Revenue in Millions : 18.20%
2013 Revenue in Millions :
Growth (%) :
Main Therapeutic Indication : Oncology
Currency : USD
2015 Revenue in Millions : 300
2014 Revenue in Millions : 353
Growth (%) : 18%
Main Therapeutic Indication : Oncology
Currency : USD
2016 Revenue in Millions : 379
2015 Revenue in Millions : 340
Growth (%) : 12
Main Therapeutic Indication : Oncology
Currency : USD
2017 Revenue in Millions : 479
2016 Revenue in Millions : 444
Growth (%) : 8
Main Therapeutic Indication : Oncology
Currency : USD
2018 Revenue in Millions : 477
2017 Revenue in Millions : 436
Growth (%) : 9%
Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
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).