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1. B 1793
2. B 1939
3. B-1793
4. B-1939
5. E 7389
6. E-7389
7. Er 086526
8. Er-086526
9. Er-86526
10. Er086526
11. Eribulin
12. Eribulin (as Mesylate)
13. Eribulin Mesilate
14. Eribulin Monomethanesulfonate
15. Halaven
16. Nsc 707389
17. Nsc-707389
18. Nsc707389
1. Halaven
2. Eribulin Mesilate
3. 441045-17-6
4. Eribulin (mesylate)
5. Eribulin Mesylate [usan]
6. Eribulin (as Mesylate)
7. E7389
8. Eribulin Monomethanesulfonate
9. Av9u0660cw
10. Chebi:70710
11. E 7389
12. E-7389
13. Eribulin Mesilate (jan)
14. Eribulin Mesylate (usan)
15. B-1939
16. (1s,3s,6s,9s,12s,14r,16r,18s,20r,21r,22s,26r,29s,31r,32s,33r,35r,36s)-20-[(2s)-3-amino-2-hydroxypropyl]-21-methoxy-14-methyl-8,15-dimethylidene-2,19,30,34,37,39,40,41-octaoxanonacyclo[24.9.2.13,32.13,33.16,9.112,16.018,22.029,36.031,35]hentetracontan-24-one;methanesulfonic Acid
17. Eribulin Mesilate [jan]
18. Nsc-707389
19. Er-086526
20. Unii-av9u0660cw
21. Halaven (tn)
22. B1939 Mesylate
23. E7389 Mesylate
24. Er-086526 Mesylate
25. Chembl1683544
26. Eribulin Mesylate [vandf]
27. Eribulin Mesilate [mart.]
28. Eribulin Mesilate [who-dd]
29. Ex-a4873
30. Eribulin Mesylate [ema Epar]
31. Hy-13442a
32. Eribulin Mesylate [orange Book]
33. Eribulin Monomethanesulfonate [mi]
34. D08914
35. Q27882076
36. B1939 Mesylate; E7389 Mesylate; Er-086526 Mesylate
37. (2r,3r,3as,7r,8as,9s,10ar,11s,12r,13ar,13bs,15s,18s,21s,24s,26r,28r,29as)-2-((2s)-3-amino-2-hydroxypropyl)-3-methoxy-26-methyl-20,27-dimethylidenehexacosahydro-11,15:18,21:24,28-triepoxy-7,9-ethano-12,15-methano-9h,15h-furo(3,2-i)furo(2',3':5,6)pyrano(4,3-b)(1,4)dioxacyclopentacosin-5(4h)-one Methanesulfonate (salt)
38. 11,15:18,21:24,28-triepoxy-7,9-ethano-12,15-methano-9h,15h-furo(3,2-i)furo(2',3':5,6)pyrano(4,3-b)(1,4)dioxacyclopentacosin-5(4h)-one, 2-((2s)-3- Amino-2-hydroxypropyl)hexacosahydro-3-methoxy-26-methyl-20,27-bis(methylene)-, 2r,3r,3as,7r,8as,9s,10ar,11s,12r,13ar,13bs,15s,18s,21s,24s,26r,28r,29as)-, Methanesulfonate (salt)
39. 2-(3-amino-2-hydroxypropyl)hexacosahydro-3-methoxy-26-methyl-20,27-bis(methylene)11,15-18,21-24,28-triepoxy-7,9-ethano-12,15-methano-9h,15h-furo(3,2-i)furo(2',3'-5,6)pyrano(4,3-b)(1,4)dioxacyclopentacosin-5-(4h)-one Methanesulfonate
Molecular Weight | 826.0 g/mol |
---|---|
Molecular Formula | C41H63NO14S |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 15 |
Rotatable Bond Count | 4 |
Exact Mass | 825.39692686 g/mol |
Monoisotopic Mass | 825.39692686 g/mol |
Topological Polar Surface Area | 209 Ų |
Heavy Atom Count | 57 |
Formal Charge | 0 |
Complexity | 1470 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 19 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 2 | |
---|---|
Drug Name | Halaven |
PubMed Health | Eribulin (Injection) |
Drug Classes | Antineoplastic Agent |
Drug Label | HALAVEN (eribulin mesylate) Injection is a non-taxane microtubule dynamics inhibitor. Eribulin mesylate is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai. The chemical name for eribulin mesyl... |
Active Ingredient | Eribulin mesylate |
Dosage Form | Solution |
Route | Intravenous |
Strength | 1mg/2ml (0.5mg/ml) |
Market Status | Prescription |
Company | Eisai |
2 of 2 | |
---|---|
Drug Name | Halaven |
PubMed Health | Eribulin (Injection) |
Drug Classes | Antineoplastic Agent |
Drug Label | HALAVEN (eribulin mesylate) Injection is a non-taxane microtubule dynamics inhibitor. Eribulin mesylate is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai. The chemical name for eribulin mesyl... |
Active Ingredient | Eribulin mesylate |
Dosage Form | Solution |
Route | Intravenous |
Strength | 1mg/2ml (0.5mg/ml) |
Market Status | Prescription |
Company | Eisai |
Halaven monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimens for advanced disease (see section 5. 1). Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.
Halaven is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease (see section 5. 1).
L01XX41
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35948
Submission : 2021-05-27
Status : Active
Type : II
NDC Package Code : 71796-044
Start Marketing Date : 2021-11-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & novel modalities with ICH-grade quality.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37054
Submission : 2023-05-29
Status : Active
Type : II
Available Reg Filing : ASMF |
NDC Package Code : 58272-208
Start Marketing Date : 2012-06-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-02-03
Pay. Date : 2021-12-17
DMF Number : 36433
Submission : 2021-11-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36628
Submission : 2022-04-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38698
Submission : 2023-12-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40279
Submission : 2024-08-29
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-13
Pay. Date : 2023-09-22
DMF Number : 37559
Submission : 2023-01-31
Status : Active
Type : II
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Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
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Details:
Eribulin EVER Pharma is a microtubule inhibitor which is indicated for the treatment of locally advanced or metastatic breast cancer and unresectable liposarcoma.
Lead Product(s): Eribulin,Inapplicable
Therapeutic Area: Oncology Brand Name: Eribulin EVER Pharma
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 16, 2024
Lead Product(s) : Eribulin,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
EVER Pharma gained EU-Approval for Advanced Cancer Treatment
Details : Eribulin EVER Pharma is a microtubule inhibitor which is indicated for the treatment of locally advanced or metastatic breast cancer and unresectable liposarcoma.
Product Name : Eribulin EVER Pharma
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 16, 2024
Details:
Undisclosed
Lead Product(s): Encoberminogene Rezmadenovec,Eribulin
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Exelixis
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 04, 2025
Lead Product(s) : Encoberminogene Rezmadenovec,Eribulin
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Exelixis
Deal Size : Inapplicable
Deal Type : Inapplicable
Zanzalintinib Combined With Eribulin in Advanced Liposarcoma and Leiomyosarcoma
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 04, 2025
Details:
Undisclosed
Lead Product(s): Melphalan,Eribulin,Vinorelbine Tartrate,Capecitabine
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Cytotoxic Drug
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 13, 2025
Lead Product(s) : Melphalan,Eribulin,Vinorelbine Tartrate,Capecitabine
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
March 13, 2025
Details:
Eribulin Mesylate, a non-taxane microtubule dynamics inhibitor used for the treatment of breast cancer, is expected to be the first generic approval on the market.
Lead Product(s): Eribulin,Inapplicable
Therapeutic Area: Oncology Brand Name: Eribulin Mesylate-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 04, 2024
Lead Product(s) : Eribulin,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Gland Pharma Receives USFDA Approval for Eribulin Mesylate Injection
Details : Eribulin Mesylate, a non-taxane microtubule dynamics inhibitor used for the treatment of breast cancer, is expected to be the first generic approval on the market.
Product Name : Eribulin Mesylate-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 04, 2024
Details:
Undisclosed
Lead Product(s): Zanidatamab,Eribulin,Vinorelbine Tartrate,Gemcitabine,Capecitabine
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 30, 2024
Lead Product(s) : Zanidatamab,Eribulin,Vinorelbine Tartrate,Gemcitabine,Capecitabine
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Antibody
Upfront Cash : Inapplicable
May 30, 2024
Details:
Under the agreement, Kexing licenses Eribulin Mesylate Injection, indicated for patients with locally advanced or metastatic breast cancer, from Xiling Lab
Lead Product(s): Eribulin,Inapplicable
Therapeutic Area: Oncology Brand Name: Eribulin Mesylate-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Kexing Biopharm
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 01, 2024
Lead Product(s) : Eribulin,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Kexing Biopharm
Deal Size : Undisclosed
Deal Type : Agreement
Kexing Introduces Eribulin Mesylate Injection, Expanding Overseas Product Offerings
Details : Under the agreement, Kexing licenses Eribulin Mesylate Injection, indicated for patients with locally advanced or metastatic breast cancer, from Xiling Lab
Product Name : Eribulin Mesylate-Generic
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
May 01, 2024
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 12, 2023
EPOCH: Eribulin and Pembrolizumab in Ovarian/Uterine Carcinosarcoma
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 17, 2022
Details:
Halaven (eribulin) is a microtubule dynamics inhibitor in the halichondrin class with a novel mechanism of action, s a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai.
Lead Product(s): Eribulin,Inapplicable
Therapeutic Area: Oncology Brand Name: Halaven
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 09, 2022
Lead Product(s) : Eribulin,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Eisai Presents Results of Post-Hoc Analysis of Eribulin Mesylate (HALAVEN®) at the European Socie...
Details : Halaven (eribulin) is a microtubule dynamics inhibitor in the halichondrin class with a novel mechanism of action, s a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai.
Product Name : Halaven
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 09, 2022
A Study of SDX-7320 in Combination With Eribulin for People With Breast Cancer
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 06, 2022
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PharmaCompass offers a list of Eribulin 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 Eribulin manufacturer or Eribulin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Eribulin manufacturer or Eribulin supplier.
PharmaCompass also assists you with knowing the Eribulin API Price utilized in the formulation of products. Eribulin API Price is not always fixed or binding as the Eribulin Price is obtained through a variety of data sources. The Eribulin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Eribulin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eribulin, including repackagers and relabelers. The FDA regulates Eribulin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eribulin 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 Eribulin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eribulin supplier is an individual or a company that provides Eribulin active pharmaceutical ingredient (API) or Eribulin finished formulations upon request. The Eribulin suppliers may include Eribulin API manufacturers, exporters, distributors and traders.
click here to find a list of Eribulin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eribulin DMF (Drug Master File) is a document detailing the whole manufacturing process of Eribulin active pharmaceutical ingredient (API) in detail. Different forms of Eribulin DMFs exist exist since differing nations have different regulations, such as Eribulin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eribulin DMF submitted to regulatory agencies in the US is known as a USDMF. Eribulin USDMF includes data on Eribulin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eribulin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eribulin 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 Eribulin Drug Master File in Japan (Eribulin JDMF) empowers Eribulin 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 Eribulin JDMF during the approval evaluation for pharmaceutical products. At the time of Eribulin 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 Eribulin 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 Eribulin Drug Master File in Korea (Eribulin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eribulin. The MFDS reviews the Eribulin KDMF as part of the drug registration process and uses the information provided in the Eribulin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Eribulin 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 Eribulin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Eribulin suppliers with KDMF on PharmaCompass.
A Eribulin written confirmation (Eribulin WC) is an official document issued by a regulatory agency to a Eribulin manufacturer, verifying that the manufacturing facility of a Eribulin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Eribulin APIs or Eribulin finished pharmaceutical products to another nation, regulatory agencies frequently require a Eribulin WC (written confirmation) as part of the regulatory process.
click here to find a list of Eribulin 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 Eribulin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Eribulin 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 Eribulin 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 Eribulin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Eribulin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Eribulin suppliers with NDC on PharmaCompass.
Eribulin 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 Eribulin 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 Eribulin GMP manufacturer or Eribulin GMP API supplier for your needs.
A Eribulin CoA (Certificate of Analysis) is a formal document that attests to Eribulin's compliance with Eribulin specifications and serves as a tool for batch-level quality control.
Eribulin CoA mostly includes findings from lab analyses of a specific batch. For each Eribulin 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.
Eribulin may be tested according to a variety of international standards, such as European Pharmacopoeia (Eribulin EP), Eribulin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eribulin USP).