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Chemistry

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Also known as: Halaven, Eribulin mesilate, 441045-17-6, Eribulin (mesylate), Eribulin mesylate [usan], Eribulin (as mesylate)
Molecular Formula
C41H63NO14S
Molecular Weight
826.0  g/mol
InChI Key
QAMYWGZHLCQOOJ-WRNBYXCMSA-N
FDA UNII
AV9U0660CW

Eribulin
Eribulin Mesylate is the mesylate salt of a synthetic analogue of halichondrin B, a substance derived from a marine sponge (Lissodendoryx sp.) with antineoplastic activity. Eribulin binds to the vinca domain of tubulin and inhibits the polymerization of tubulin and the assembly of microtubules, resulting in inhibition of mitotic spindle assembly, induction of cell cycle arrest at G2/M phase, and, potentially, tumor regression.
1 2D Structure

Eribulin

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(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
2.1.2 InChI
InChI=1S/C40H59NO11.CH4O3S/c1-19-11-24-5-7-28-20(2)12-26(45-28)9-10-40-17-33-36(51-40)37-38(50-33)39(52-40)35-29(49-37)8-6-25(47-35)13-22(42)14-27-31(16-30(46-24)21(19)3)48-32(34(27)44-4)15-23(43)18-41;1-5(2,3)4/h19,23-39,43H,2-3,5-18,41H2,1,4H3;1H3,(H,2,3,4)/t19-,23+,24+,25-,26+,27+,28+,29+,30-,31+,32-,33-,34-,35+,36+,37+,38-,39+,40+;/m1./s1
2.1.3 InChI Key
QAMYWGZHLCQOOJ-WRNBYXCMSA-N
2.1.4 Canonical SMILES
CC1CC2CCC3C(=C)CC(O3)CCC45CC6C(O4)C7C(O6)C(O5)C8C(O7)CCC(O8)CC(=O)CC9C(CC(C1=C)O2)OC(C9OC)CC(CN)O.CS(=O)(=O)O
2.1.5 Isomeric SMILES
C[C@@H]1C[C@@H]2CC[C@H]3C(=C)C[C@@H](O3)CC[C@]45C[C@@H]6[C@H](O4)[C@H]7[C@@H](O6)[C@@H](O5)[C@@H]8[C@@H](O7)CC[C@@H](O8)CC(=O)C[C@H]9[C@H](C[C@H](C1=C)O2)O[C@@H]([C@@H]9OC)C[C@@H](CN)O.CS(=O)(=O)O
2.2 Other Identifiers
2.2.1 UNII
AV9U0660CW
2.3 Synonyms
2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date
2007-11-26
3 Chemical and Physical Properties
Molecular Weight 826.0 g/mol
Molecular Formula C41H63NO14S
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count15
Rotatable Bond Count4
Exact Mass825.39692686 g/mol
Monoisotopic Mass825.39692686 g/mol
Topological Polar Surface Area209 Ų
Heavy Atom Count57
Formal Charge0
Complexity1470
Isotope Atom Count0
Defined Atom Stereocenter Count19
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameHalaven
PubMed HealthEribulin (Injection)
Drug ClassesAntineoplastic Agent
Drug LabelHALAVEN (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 IngredientEribulin mesylate
Dosage FormSolution
RouteIntravenous
Strength1mg/2ml (0.5mg/ml)
Market StatusPrescription
CompanyEisai

2 of 2  
Drug NameHalaven
PubMed HealthEribulin (Injection)
Drug ClassesAntineoplastic Agent
Drug LabelHALAVEN (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 IngredientEribulin mesylate
Dosage FormSolution
RouteIntravenous
Strength1mg/2ml (0.5mg/ml)
Market StatusPrescription
CompanyEisai

4.2 Drug Indication

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).


5 Pharmacology and Biochemistry
5.1 FDA Pharmacological Classification
5.1.1 Pharmacological Classes
Microtubule Inhibitor [EPC]; Microtubule Inhibition [PE]
5.2 ATC Code

L01XX41


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Natco Pharma Ltd

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Eribulin mesylate

Registration Number : 304MF10030

Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...

Initial Date of Registration : 2022-02-10

Latest Date of Registration : 2022-02-10

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Eribulin mesylate

Registration Number : 301MF10104

Registrant's Address : 4-6-10 Koishikawa, Bunkyo-ku, Tokyo

Initial Date of Registration : 2019-12-10

Latest Date of Registration : 2019-12-10

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Eribulin Mesylate IH

Date of Issue : 2022-09-30

Valid Till : 2025-07-02

Written Confirmation Number : WC-0226

Address of the Firm : D-24 & D-24/1, M.I.D.C., Kurkumbh, Taluka: Daund, District. Pune-413 802, Mahara...

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Natco Pharma

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Erbulin Mesylate IH

Date of Issue : 2022-09-16

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Address of the Firm : S.No.73/1A, 74/7B,78/1B,79/1,2B,3,4B,5,6A,6B,7,80/1,2,3,4,84/1,2,3A,5A,6,7A,85/2...

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Eisai

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Eribulin mesylate

Registrant Name : Korea Ezai Co., Ltd.

Registration Date : 2012-08-09

Registration Number : Su3834-1-ND

Manufacturer Name : Kashima Plant, Eisai Co., Lt...

Manufacturer Address : 22 Sunayama, Kamisu-shi, Ibaraki-ken 314-0255

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ERIBULIN MESYLATE

NDC Package Code : 71796-044

Start Marketing Date : 2021-11-30

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ERIBULIN MESYLATE

NDC Package Code : 58272-208

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ERIBULIN MESYLATE

NDC Package Code : 11071-892

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NDC Package Code : 11071-891

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ERIBULIN

NDC Package Code : 14593-949

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NDC Package Code : 14593-945

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NDC Package Code : 66499-0074

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ERIBULIN MESYLATE

NDC Package Code : 61662-0019

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ERIBULIN MESYLATE

NDC Package Code : 13612-0022

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Chongqing Biocare Pharmaceutical Lt...

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ERIBULIN MESYLATE

NDC Package Code : 33656-0018

Start Marketing Date : 2022-04-01

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Eribulin

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...

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 portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale
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Eribulin Mesylate

About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...

Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout the entire API life cycle, from product development through sales. Transo-Pharm serves as a sourcing and regulatory marketing agent for API manufacturers. It aids clients in establishing DMFs and provides GMP consulting. With a dedicated regulatory department, a warehouse, proprietary IPs for API processes, and partnerships with laboratories, Transo-Pharm offers a wide range of services. It operates from its offices in Shanghai, Hong Kong, Singapore, and the US.
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03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

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Eribulin Mesylate

About the Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...

​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in Nantong, Jiangsu and Jinan, Shandong, with more than 13,000㎡ of production sites. While supplying products to customers, the company also provides services such as technology development, technology transfer and technology exchange, aiming to provide customers with comprehensive supply and solutions in the biomedical industry.
Shanghai Minbiotech CB

04

ChemExpress

China
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.

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Eribulin

About the Company : Founded in 2006, ChemExpress specializes in offering CRO & CDMO services for pharmaceutical and biotech companies, focusing on small molecules, biologics and new modalities such as...

Founded in 2006, ChemExpress specializes in offering CRO & CDMO services for pharmaceutical and biotech companies, focusing on small molecules, biologics and new modalities such as ADCs/XDCs, peptides and PROTACs. Our comprehensive platform is engaged in the research and development, manufacturing and supply of regulatory starting materials, novel building blocks, intermediates, reference compounds, APIs and drug products (solid & semi-solid, biologics liquid & lyophilized). We support our clients' projects from early drug discovery, process development to commercialization.
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05

ALP Pharm

China
ESCRS
Not Confirmed
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ALP Pharm

China
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ESCRS
Not Confirmed

Eribulin

About the Company : ALP Pharm began to manufacture some APIs in the partner's facilities in 2007. Some of our APIs have been approved by EDQM and US FDA. Our professional regulatory compliance experts...

ALP Pharm began to manufacture some APIs in the partner's facilities in 2007. Some of our APIs have been approved by EDQM and US FDA. Our professional regulatory compliance experts in the USA, United Kingdom, and India have more than 10 years of Western cGMP experience. Prior to working for ALP Pharm, they have helped more than 30 pharmaceutical companies achieve ANDAs and DMFs and also helped some branded companies to pass FDA inspections for the NDA and IND. Meanwhile, they helped some European pharmaceutical companies to get licenses for finished drugs including oral solid dosages and injections, as well as COSs and EDMFs.
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06

Apino Pharma

China
ESCRS
Not Confirmed
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Apino Pharma

China
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ESCRS
Not Confirmed

Eribulin

About the Company : Apino Pharma prides itself on being an innovation-driven company that strives to continuously improve its products and services. Our dedicated innovation team collaborates with the...

Apino Pharma prides itself on being an innovation-driven company that strives to continuously improve its products and services. Our dedicated innovation team collaborates with the world’s leading research institutes and universities to develop cutting-edge formulations and technologies that bring value to our customers. We are committed to exploring new opportunities presented by technology, science and global best practices to provide quality products and services that meet and exceed our customers’ needs.
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07

Aspen Bio

India
ESCRS
Not Confirmed
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Aspen Bio

India
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ESCRS
Not Confirmed

Eribulin

About the Company : Aspen Bio is a multifaceted company that was established in 2014. Aspen Bio defines development and novelty as a challenge for competitive markets to provide improved health servic...

Aspen Bio is a multifaceted company that was established in 2014. Aspen Bio defines development and novelty as a challenge for competitive markets to provide improved health services to people, through pioneering Research & Development in agreement with the latest principles to ensure safe and secured wellness. The Company is established in bringing the benefit of high quality APIs & Finished Formulations, yet reasonably priced, to patients in India and other emerging markets.
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08

ESCRS
Not Confirmed
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ESCRS
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Eribulin

About the Company : Emcure Pharmaceuticals Ltd. is a fast-growing fully integrated Indian pharmaceutical company with a global presence engaged in developing, manufacturing, and marketing a broad rang...

Emcure Pharmaceuticals Ltd. is a fast-growing fully integrated Indian pharmaceutical company with a global presence engaged in developing, manufacturing, and marketing a broad range of pharmaceutical products. Its core strength lies in developing and manufacturing differentiated pharmaceutical products in-house, which it commercializes across geographies. Emcure has launched 6 biosimilars in the Domestic Market & RoW markets & Its subsidiary - Gennova is leading the creation of India’s first indigenous mRNA vaccine to combat COVID- 19 which is currently under trial.
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09

ESCRS
Not Confirmed
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ESCRS
Not Confirmed

Eribulin

About the Company : Established in 2010, Mac-Chem is a NMM Group company. Mac-Chem is focused on oncology and other niche specialty APIs. It supplies quality APIs to the top 15 oncology players in Ind...

Established in 2010, Mac-Chem is a NMM Group company. Mac-Chem is focused on oncology and other niche specialty APIs. It supplies quality APIs to the top 15 oncology players in India. It is also the sole manufacturer of some of the molecules in the oncology segment and general segment. The company’s investments are mostly geared toward exports, especially to regulated markets. Mac-Chem has a cGMP-compliant manufacturing facility near Mumbai in India. The company’s facility is USFDA, EDQM, COFEPRIS, ANVISA, MFDS-Korea, WHO-GMP-approved and ISO-certified. Mac-Chem enjoys a global reach, serving more than 40 countries.
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10

Natco Pharma

India
ESCRS
Not Confirmed
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Natco Pharma

India
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ESCRS
Not Confirmed

Eribulin

About the Company : NATCO PHARMA LIMITED was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million. With a modest beginning of operations as a single unit with 20 e...

NATCO PHARMA LIMITED was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million. With a modest beginning of operations as a single unit with 20 employees, NATCO today has five manufacturing facilities spread across India with dedicated modern research laboratories, capabilities in New Drug Development, etc.NATCO family currently consists of more than 2500 employees, we are consistently ranked among fastest growing pharmaceutical companies in India. NATCO is well recognized for its innovation in Pharmaceutical R&D.
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API Reference Price

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20-Apr-2022
29-Jul-2025
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Drugs in Development

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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

Ever Pharma CB

01

Ever Pharma

Austria
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Lead Product(s) : Eribulin,Inapplicable

Therapeutic Area : Oncology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

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

Ever Pharma CB

Details:

TQB2930 is a drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Breast Neoplasms.


Lead Product(s): TQB2930,Capecitabine,Gemcitabine,Vinorelbine Tartrate,Eribulin

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Undisclosed

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 02, 2025

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02

ESCRS
Not Confirmed
ESCRS
Not Confirmed

Details : TQB2930 is a drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Breast Neoplasms.

Product Name : Undisclosed

Product Type : Undisclosed

Upfront Cash : Inapplicable

July 02, 2025

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Details:

Evorpacept is a Protein drug candidate, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of Breast Neoplasms.


Lead Product(s): Evorpacept,Trastuzumab,Paclitaxel,Capecitabine,Eribulin,Gemcitabine,Vinorelbine Tartrate,Cetuximab,Irinotecan Hydrochloride,

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase I/ Phase IIProduct Type: Protein

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 06, 2025

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03

ALX Oncology

U.S.A
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ESCRS
Not Confirmed

ALX Oncology

U.S.A
arrow
ESCRS
Not Confirmed

Details : Evorpacept is a Protein drug candidate, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of Breast Neoplasms.

Product Name : Undisclosed

Product Type : Protein

Upfront Cash : Inapplicable

June 06, 2025

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04

ESCRS
Not Confirmed

05

ESCRS
Not Confirmed

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

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06

ESCRS
Not Confirmed
ESCRS
Not Confirmed

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

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07

ESCRS
Not Confirmed

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

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08

Xiling Lab

China
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ESCRS
Not Confirmed

Xiling Lab

China
arrow
ESCRS
Not Confirmed

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

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09

MEDSIR

Spain
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ESCRS
Not Confirmed

MEDSIR

Spain
arrow
ESCRS
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

April 12, 2023

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  • Development Update

Details:

Undisclosed


Lead Product(s): Eribulin,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Other Small Molecule

Sponsor: Eisai Inc | Merck & Co

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 17, 2022

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10

Australia New Zealand Gynaecological Oncology Group

Country
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ESCRS
Not Confirmed

Australia New Zealand Gynaecological Oncology Group

Country
arrow
ESCRS
Not Confirmed

Lead Product(s) : Eribulin,Inapplicable

Therapeutic Area : Oncology

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : Eisai Inc | Merck & Co

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 17, 2022

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INTERMEDIATE SUPPLIERS

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

CAS Number : 157322-83-3

End Use API : Eribulin

About The Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...

Shanghai Minbiotech CB

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

CAS Number : 871348-24-2

End Use API : Eribulin

About The Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...

Shanghai Minbiotech CB

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

CAS Number : 157322-47-9

End Use API : Eribulin

About The Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...

Shanghai Minbiotech CB

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

CAS Number : 253128-10-8

End Use API : Eribulin

About The Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...

Shanghai Minbiotech CB

05

ChemExpress

China
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.

CAS Number : 157322-83-3

End Use API : Eribulin

About The Company : Founded in 2006, ChemExpress specializes in offering CRO & CDMO services for pharmaceutical and biotech companies, focusing on small molecules, biologics and ne...

Company Banner

06

ChemExpress

China
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.

CAS Number : 157322-47-9

End Use API : Eribulin

About The Company : Founded in 2006, ChemExpress specializes in offering CRO & CDMO services for pharmaceutical and biotech companies, focusing on small molecules, biologics and ne...

Company Banner

07

ChemExpress

China
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.

CAS Number : 871360-33-7

End Use API : Eribulin

About The Company : Founded in 2006, ChemExpress specializes in offering CRO & CDMO services for pharmaceutical and biotech companies, focusing on small molecules, biologics and ne...

Company Banner

08

ChemExpress

China
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.

CAS Number : 137688-20-1

End Use API : Eribulin

About The Company : Founded in 2006, ChemExpress specializes in offering CRO & CDMO services for pharmaceutical and biotech companies, focusing on small molecules, biologics and ne...

Company Banner

09

ChemExpress

China
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.

CAS Number : 1808153-91-4

End Use API : Eribulin

About The Company : Founded in 2006, ChemExpress specializes in offering CRO & CDMO services for pharmaceutical and biotech companies, focusing on small molecules, biologics and ne...

Company Banner

10

ChemExpress

China
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.

CAS Number : 1808153-90-3

End Use API : Eribulin

About The Company : Founded in 2006, ChemExpress specializes in offering CRO & CDMO services for pharmaceutical and biotech companies, focusing on small molecules, biologics and ne...

Company Banner
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FDA Orange Book

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01

DR REDDYS

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

RLD : No

TE Code : AP

ERIBULIN MESYLATE

Brand Name : ERIBULIN MESYLATE

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 1MG/2ML (0.5MG/ML)

Approval Date : 2025-07-03

Application Number : 217473

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Dr Reddy Company Banner

02

ESCRS
Not Confirmed
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ERIBULIN MESYLATE

Brand Name : ERIBULIN MESYLATE

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 1MG/2ML (0.5MG/ML)

Approval Date : 2024-10-01

Application Number : 217250

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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ESCRS
Not Confirmed
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ERIBULIN MESYLATE

Brand Name : ERIBULIN MESYLATE

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 1MG/2ML (0.5MG/ML)

Approval Date : 2025-03-04

Application Number : 218743

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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EISAI INC

U.S.A
ESCRS
Not Confirmed
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EISAI INC

U.S.A
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ERIBULIN MESYLATE

Brand Name : HALAVEN

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 1MG/2ML (0.5MG/ML)

Approval Date : 2010-11-15

Application Number : 201532

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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GLAND

India
ESCRS
Not Confirmed
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GLAND

India
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Not Confirmed

ERIBULIN MESYLATE

Brand Name : ERIBULIN MESYLATE

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 1MG/2ML (0.5MG/ML)

Approval Date : 2024-04-05

Application Number : 218047

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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ESCRS
Not Confirmed
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ERIBULIN MESYLATE

Brand Name : ERIBULIN MESYLATE

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 1MG/2ML (0.5MG/ML)

Approval Date : 2024-07-18

Application Number : 214850

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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SANDOZ

Switzerland
ESCRS
Not Confirmed
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SANDOZ

Switzerland
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Not Confirmed

ERIBULIN MESYLATE

Brand Name : ERIBULIN MESYLATE

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 1MG/2ML (0.5MG/ML)

Approval Date : 2025-06-09

Application Number : 214310

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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XILING LAB

China
ESCRS
Not Confirmed
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XILING LAB

China
arrow
ESCRS
Not Confirmed

ERIBULIN MESYLATE

Brand Name : ERIBULIN MESYLATE

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 1MG/2ML (0.5MG/ML)

Approval Date : 2025-08-05

Application Number : 218142

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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JIANGXI KVVIT PHARM

Country
ESCRS
Not Confirmed
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JIANGXI KVVIT PHARM

Country
arrow
ESCRS
Not Confirmed

ERIBULIN MESYLATE

Brand Name : ERIBULIN MESYLATE

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 1MG/2ML (0.5MG/ML)

Approval Date : 2024-06-28

Application Number : 218281

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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Europe

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01

ESCRS
Not Confirmed
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Eribulini mesilas

Brand Name : Halaven

Dosage Form : Inj Solution

Dosage Strength : 1mg/2ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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ESCRS
Not Confirmed
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eribulinmesilat

Brand Name : HALAVEN

Dosage Form : SOLUTION FOR INJECTION

Dosage Strength : 0.44 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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Not Confirmed
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Eribulin

Brand Name : Halaven

Dosage Form : Eribulina 0.88Mg 2Ml 1 Units Parenteral Use

Dosage Strength : 1 vial EV 0.88 mg 2 ml 0.44 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Not Confirmed
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Eribulin

Brand Name : Halaven

Dosage Form : Injection fluid, resolution

Dosage Strength : 0.44 mg/ml

Packaging : Hood glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Canada

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01

ESCRS
Not Confirmed
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ESCRS
Not Confirmed

ERIBULIN MESYLATE

Brand Name : HALAVEN

Dosage Form : SOLUTION

Dosage Strength : 0.5MG/ML

Packaging : 2ML

Approval Date :

Application Number : 2377438

Regulatory Info :

Registration Country : Canada

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ESCRS
Not Confirmed
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ERIBULIN MESYLATE

Brand Name : NAT-ERIBULIN

Dosage Form : SOLUTION

Dosage Strength : 0.5MG/ML

Packaging :

Approval Date :

Application Number : 2539136

Regulatory Info :

Registration Country : Canada

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Australia

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01

ESCRS
Not Confirmed
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ESCRS
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Eribulin

Brand Name : Halaven

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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ESCRS
Not Confirmed
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Eribulin

Brand Name : Halaven

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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ESCRS
Not Confirmed
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Eribulin

Brand Name : Halaven

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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ESCRS
Not Confirmed
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Eribulin

Brand Name : Halaven

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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South Africa

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Eisai Pharmaceuticals Africa (Pty) Ltd

Country
ESCRS
Not Confirmed
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Eisai Pharmaceuticals Africa (Pty) Ltd

Country
arrow
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Not Confirmed

Eribulin Mesilate

Brand Name : Halaven

Dosage Form : INJ

Dosage Strength : 10mg

Packaging : 2X1mg/2ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Listed Dossiers

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  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Digital Content Digital Content

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Eribulin

Brand Name :

Dosage Form : Injection

Dosage Strength : 0.5MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Dr Reddy Company Banner

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info : Lead Market Dossiers- Filed

Eribulin

Dosage : Injection

Dosage Strength : 0.5MG/ML

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Dr Reddy Company Banner

02

NanoAlvand

Iran
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.

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Digital Content Digital Content

Regulatory Info :

Registration Country : Iran

Eribulin Mesylate

Brand Name : Nibulin®

Dosage Form : Solution for Injection

Dosage Strength : 1MG/2ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Iran

NanoAlvand

02

NanoAlvand

Iran
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.

Flag Iran
Digital Content Digital Content

Packaging :

Regulatory Info :

Eribulin Mesylate

Dosage : Solution for Injection

Dosage Strength : 1MG/2ML

Brand Name : Nibulin®

Approval Date :

Application Number :

Registration Country : Iran

NanoAlvand
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DATA COMPILATION #PharmaFlow

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FDA’s first generic approvals slump 21% in 2024; Novartis’ top seller Entresto, cancer blockbuster Tasigna lead 2024 patent cliff
A watershed moment in the journey of a drug is when it transitions from being a patented, high‐priced innovator product to an affordable generic.Through an inaugural approval, or a “first generic”,  the US Food Drug Administration (FDA) permits a manufacturer to market a generic version of a brand‐name drug — a process that, when successful, grants 180 days of exclusivity to the generic sponsor. This exclusivity is especially valuable when the drug in question is a blockbuster.In FDA’s fiscal year 2024 (i.e. from October 1, 2023 to September 30, 2024), the number of first-time generic drug approvals decreased by 21.3 percent — from 89 in FY 2023 to 70 in FY 2024, the lowest in at least nine years.Lupin emerged as a frontrunner in first generics, increasing its approvals from three in FY 2023 to seven in FY 2024, Apotex and Zydus Lifesciences from four to six, and Dr. Reddy’s from two to four. In contrast, Teva, Amneal, and Sun Pharma experienced a decline.Overall, neurology led the way with 10 approvals, while immunology saw eight, including three approvals in dermatology. Oncology and cardiology/vascular disease saw six approvals each. Ophthalmology saw five while psychiatry, and infectious diseases each contributed four approvals. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Novartis’ top seller Entresto, blockbuster Tasigna among six key drugs hit by generic rivalsIn 2024, the tide turned sharply for Novartis as it lost exclusivity for six of its drugs. Among them was its blockbuster Entresto, that has generated US$ 29.2 billion in revenue so far, including US$ 7.8 billion in 2024.A combination of sacubitril and valsartan, Entresto has transformed heart failure management. Entresto was the primary driver of Novartis’ sales growth last year. It was also one of the 10 drugs selected by the Biden administration in 2023 for Medicare price negotiations. Novartis has been fighting a fierce legal battle to protect Entresto from generic competition. In 2024, Entresto’s generic saga reached a crescendo. Alembic Pharmaceuticals, Laurus Labs, and Crystal Pharmaceutical’s generic versions of Entresto received FDA approval in May last year. But the Swiss drugmaker has noted that as of January 2025, there were no Entresto generics available in the US.Novartis’ Tasigna (nilotinib) has been a cornerstone in the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). Apotex won approvals for generics of 50 mg, 150 mg, and 200 mg of nilotinib formulations, thereby offering a more affordable option for both adult and pediatric patients. Owing to the generics, Tasigna’s sales fell 10 percent in 2024.Novartis’ Mekinist (trametinib), Votrient (pazopanib), Rydapt (midostaurin), and Promacta (eltrombopag) have long been critical treatments in oncology and hematology. With generic competition hitting these key assets, Novartis is now aggressively forging deals to strengthen its pipeline. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  FDA clears first generics for Neurocrine’s Ingrezza, Supernus’s Gocovri, ALS drugsIn psychiatry, Neurocrine Biosciences’ Ingrezza (valbenazine) capsules have carved out a niche for themselves as a first-in-class treatment for tardive dyskinesia, a movement disorder that can develop as a side effect of long-term use of antipsychotic meds. Two generics for Ingrezza from India’s Zydus and Lupin bagged FDA approval, as Ingrezza sales topped US$ 2.3 billion last year.Zydus also won first generic approval for Supernus Pharmaceuticals’ Gocovri (amantadine) extended-release capsules, which is a treatment of dyskinesia in Parkinson’s disease patients receiving levodopa-based therapy.Four companies received FDA approvals for their first generics of Mitsubishi Tanabe’s patented drug Radicava (edaravone). These are Dr. Reddy’s Laboratories, Gland Pharma (a Fosun Pharmaceutical subsidiary), Hikma and Long Grove. Radicava is a drug that treats amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. Another treatment for ALS from Italfarmaco — Tiglutik (riluzole) — received a first generic when FDA okayed Alkem Laboratories riluzole oral suspension. The med helps slow disease progression. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Pfizer’s Ibrance, Gilead’s Descovy, Lilly’s Olumiant treatment come under generic pressureIn oncology, Synthon Pharmaceuticals launched its generic version of Pfizer’s Ibrance (palbociclib) tablets. Generating sales of US$ 4.4 billion in 2024, this groundbreaking CDK4/6 inhibitor is Pfizer’s best-selling cancer drug. It has transformed treatment for hormone receptor-positive, HER2-negative advanced breast cancer by halting cancer cell division and significantly extending progression-free survival when combined with endocrine therapy.Descovy, a combination of emtricitabine and tenofovir alafenamide, stands as one of the most important therapies in the fight against HIV infection and related conditions. Originally developed by Gilead Sciences, Descovy has played a pivotal role in modern antiretroviral therapy, contributing US$ 2.1 billion to Gilead’s revenue in 2024. Apotex’s first generic approval for Descovy marked its second copycat for a blockbuster drug in 2024. The other generic approval it got its hands on was for Boehringer Ingelheim’s Pradaxa (dabigatran etexilate), a blood thinner that posted sales of € 845 million (US$ 883 million) in 2023.In immunology, Eli Lilly’s Olumiant (baricitinib) has emerged as an important therapy for treating inflammatory conditions such as rheumatoid arthritis. Aurobindo Pharma bagged FDA approval for generic baricitinib tablets.Ipsen’s Somatuline Depot (lanreotide) injection, a treatment for neuroendocrine tumors and endocrine disorders that generated about € 1.07 billion (US$1.1 billion) in 2023 sales, also has a generic now, with Cipla’s subsidiary InvaGen Pharmaceuticals receiving an FDA approval. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available) FDA okays copycats for opioid withdrawal med Lucemyra, weight loss drug Qsymia, contraceptive SlyndFDA also demonstrated a focused commitment to addressing two of the nation’s biggest public health concerns — the opioid crisis and obesity. Lucemyra (lofexidine), originally developed by US WorldMeds, is a non-opioid medication indicated for mitigating symptoms associated with acute opioid withdrawal and facilitating the completion of opioid discontinuation treatment. The introduction of Indoco Remedies’ generic version is poised to expand access to this critical therapy by offering a cost-effective alternative for managing substance use disorders.Vivus’ Qsymia (phentermine/topiramate), a chronic weight management therapy, also received a first generic. Actavis’ generic for Qsymia provides a more accessible option to patients striving to lose weight. Actavis is a subsidiary of Teva.FDA also approved Lupin’s first generic version of Insud Pharma’s Slynd—a progestin‑only contraceptive containing 4 mg drospirenone for use by females of reproductive potential to prevent pregnancy. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Our viewOver the next two years, several blockbusters such as Novo Nordisk’s Ozempic (semaglutide), AstraZeneca’s Farxiga (dapagliflozin), Bristol Myers Squibb’s Revlimid (lenalidomide) and its Pfizer partnered drug Eliquis (apixaban) stand to lose their patent protection. We expect more patent litigations and some exciting innovations in the generics space.

Impressions: 3501

https://www.pharmacompass.com/radio-compass-blog/fda-s-first-generic-approvals-slump-21-in-2024-novartis-top-seller-entresto-cancer-blockbuster-tasigna-lead-2024-patent-cliff

#PharmaFlow by PHARMACOMPASS
20 Feb 2025

NEWS #PharmaBuzz

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https://www.expresspharma.in/glenmark-pharmaceuticals-to-launch-eribulin-mesylate-injection-1mg-2ml-0-5-mg-ml-single-dose-vials/

EXPRESSPHARMA
02 Sep 2025

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217473

FDA
03 Jul 2025

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217250

FDA
01 Oct 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218281

FDA
28 Jun 2024

https://www.everpharma.com/news/ever-pharma-gained-eu-approval-for-advanced-cancer-treatment/

PRESS RELEASE
16 Apr 2024

https://www.indianpharmapost.com/drug-approval/gland-pharma-receives-usfda-approval-for-eribulin-mesylate-injection-15492

INDINPHARMAPOST
07 Apr 2024

Global Sales Information

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US Medicaid Prescriptions

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01

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ESCRS
Not Confirmed
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ESCRS
Not Confirmed

Company : Eisai Inc.

Eribulin Mesylate

Drug Cost (USD) : 618,194

Year : 2023

Prescribers : 24

Prescriptions : 90

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ESCRS
Not Confirmed
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Company : Eisai Inc.

Eribulin Mesylate

Drug Cost (USD) : 865,201

Year : 2022

Prescribers : 29

Prescriptions : 132

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Not Confirmed
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Company : Eisai Inc.

Eribulin Mesylate

Drug Cost (USD) : 870,082

Year : 2021

Prescribers : 32

Prescriptions : 124

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Not Confirmed
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Company : Eisai Inc.

Eribulin Mesylate

Drug Cost (USD) : 1,193,528

Year : 2020

Prescribers : 39

Prescriptions : 198

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Not Confirmed
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Company : Eisai Inc.

Eribulin Mesylate

Drug Cost (USD) : 1,302,534

Year : 2019

Prescribers : 43

Prescriptions : 183

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Not Confirmed
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Company : Eisai Inc.

Eribulin Mesylate

Drug Cost (USD) : 906,346

Year : 2018

Prescribers : 41

Prescriptions : 156

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Not Confirmed
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Company : Eisai Inc.

Eribulin Mesylate

Drug Cost (USD) : 1,046,183

Year : 2017

Prescribers : 52

Prescriptions : 185

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Not Confirmed
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Company : Eisai Inc.

Eribulin Mesylate

Drug Cost (USD) : 939,226

Year : 2016

Prescribers : 45

Prescriptions : 190

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Regulatory FDF Prices

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Brand Name : Halaven

U.S.A
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ESCRS
Not Confirmed

Brand Name : Halaven

U.S.A
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ESCRS
Not Confirmed

Eribulin

Dosage Form : Eribulina 0.88Mg 2Ml 1 Units Par...

Dosage Strength : 1 vial EV 0.88 mg 2 ml 0.44 mg/ml

Price Per Pack (Euro) : 595.79

Published in :

Country : Italy

RX/OTC/DISCN : Class H

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Brand Name : Halaven

Japan
arrow
ESCRS
Not Confirmed

Brand Name : Halaven

Japan
arrow
ESCRS
Not Confirmed

Eribulin

Dosage Form : Inj Solution

Dosage Strength : 1mg/2ml

Price Per Pack (Euro) : 225.64

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

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Brand Name : Halaven

U.S.A
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ESCRS
Not Confirmed

Brand Name : Halaven

U.S.A
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ESCRS
Not Confirmed

Eribulin

Dosage Form : Injection fluid, resolution

Dosage Strength : 0.44 mg/ml

Price Per Pack (Euro) : 417.85

Published in :

Country : Norway

RX/OTC/DISCN :

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Annual Reports

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01

Brand Name : Halaven

Eribulin Mesylate

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ESCRS
Not Confirmed

Brand Name : Halaven

Japan
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ESCRS
Not Confirmed

Eribulin Mesylate

Main Therapeutic Indication : Oncology

Currency : USD

2020 Revenue in Millions : 359

2019 Revenue in Millions : 385

Growth (%) : -7

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Brand Name : Halaven

Eribulin Mesylate

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ESCRS
Not Confirmed

Brand Name : Halaven

Japan
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ESCRS
Not Confirmed

Eribulin Mesylate

Main Therapeutic Indication : Oncology

Currency : USD

2021 Revenue in Millions : 331

2020 Revenue in Millions : 344

Growth (%) : 4

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Brand Name : Halaven

Eribulin Mesylate

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Not Confirmed

Brand Name : Halaven

Japan
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Not Confirmed

Eribulin Mesylate

Main Therapeutic Indication : Oncology

Currency : USD

2022 Revenue in Millions : 316

2021 Revenue in Millions : 331

Growth (%) : -4

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Brand Name : Halaven

Eribulin Mesylate

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Not Confirmed

Brand Name : Halaven

Japan
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Not Confirmed

Eribulin Mesylate

Main Therapeutic Indication : Oncology

Currency : USD

2023 Revenue in Millions : 260

2022 Revenue in Millions : 316

Growth (%) : -8

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Brand Name : Halaven

Eribulin Mesylate

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Not Confirmed

Brand Name : Halaven

Japan
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Eribulin Mesylate

Main Therapeutic Indication : Oncology

Currency : USD

2024 Revenue in Millions : 215

2023 Revenue in Millions : 291

Growth (%) : -26

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Brand Name : Halaven

Eribulin Mesylate

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Not Confirmed

Brand Name : Halaven

U.S.A
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Not Confirmed

Eribulin Mesylate

Main Therapeutic Indication : Oncology

Currency : USD

2017 Revenue in Millions : 380

2016 Revenue in Millions : 371

Growth (%) : 3

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Brand Name : Halaven

Eribulin Mesylate

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ESCRS
Not Confirmed

Brand Name : Halaven

U.S.A
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Not Confirmed

Eribulin Mesylate

Main Therapeutic Indication : Oncology

Currency : USD

2018 Revenue in Millions : 365

2017 Revenue in Millions : 356

Growth (%) : 2%

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Brand Name : Halaven

Eribulin Mesylate

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ESCRS
Not Confirmed

Brand Name : Halaven

Japan
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ESCRS
Not Confirmed

Eribulin Mesylate

Main Therapeutic Indication : Oncology

Currency : USD

2019 Revenue in Millions : 378

2018 Revenue in Millions : 377

Growth (%) : 0

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APIs

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FDF DOSSIERS

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Patents & EXCLUSIVITIES

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ABOUT THIS PAGE

Looking for 441045-17-6 / Eribulin API manufacturers, exporters & distributors?

Eribulin manufacturers, exporters & distributors 1

21

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.

API | Excipient name

Eribulin

Synonyms

Halaven, Eribulin mesilate, 441045-17-6, Eribulin (mesylate), Eribulin mesylate [usan], Eribulin (as mesylate)

Cas Number

441045-17-6

Unique Ingredient Identifier (UNII)

AV9U0660CW

About Eribulin

Eribulin Mesylate is the mesylate salt of a synthetic analogue of halichondrin B, a substance derived from a marine sponge (Lissodendoryx sp.) with antineoplastic activity. Eribulin binds to the vinca domain of tubulin and inhibits the polymerization of tubulin and the assembly of microtubules, resulting in inhibition of mitotic spindle assembly, induction of cell cycle arrest at G2/M phase, and, potentially, tumor regression.

Eribulin Manufacturers

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.

Eribulin Suppliers

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.

Eribulin USDMF

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.

Eribulin JDMF

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.

Eribulin KDMF

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.

Eribulin WC

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.

Eribulin NDC

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).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Eribulin API and other APIs are published in this directory by the FDA.

Unfinished drugs

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.

Compounded drug products

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 GMP

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.

Eribulin CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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