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1. Hmpl-013
1. 1194506-26-7
2. Hmpl-013
3. Hmpl013
4. Fruquintinib [who-dd]
5. Fruquintinib(hmpl-013)
6. 6-(6,7-dimethoxyquinazolin-4-yl)oxy-n,2-dimethyl-1-benzofuran-3-carboxamide
7. Fruquintinib [usan]
8. 49dxg3m5zw
9. 6-(6,7-dimethoxyquinazolin-4-yloxy)-n,2-dimethylbenzofuran-3-carboxamide
10. 3-benzofurancarboxamide, 6-((6,7-dimethoxy-4-quinazolinyl)oxy)-n,2-dimethyl-
11. 6-[(6,7-dimethoxyquinazolin-4-yl)oxy]-n,2-dimethyl-1-benzofuran-3-carboxamide
12. 6-((6,7-dimethoxyquinazolin-4-yl)oxy)-n,2-dimethylbenzofuran-3-carboxamide
13. Unii-49dxg3m5zw
14. Elunate
15. Fruquintinib [inn]
16. Fruquintinib; Hmpl-013
17. Fruquintinib (hmpl-013)
18. Schembl947183
19. Gtpl9428
20. Hmpl 013
21. Chembl4303214
22. Bcp15692
23. Ex-a2262
24. Nsc801000
25. Nsc829498
26. S5667
27. Who 10348
28. 6-[(6,7-dimethoxy-4-quinazolinyl)oxy]-n,2-dimethyl-3-benzofurancarboxamide
29. Akos026750586
30. Zinc114898570
31. Ccg-268573
32. Cs-5558
33. Db11679
34. Nsc-801000
35. Nsc-829498
36. Sb17123
37. Ncgc00481603-01
38. As-73141
39. Hmpl-013;hmpl013;hmpl 013
40. Hy-19912
41. B5864
42. A14393
43. C71641
44. A898991
45. Q27259271
46. B2693-470819
Molecular Weight | 393.4 g/mol |
---|---|
Molecular Formula | C21H19N3O5 |
XLogP3 | 3.4 |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 7 |
Rotatable Bond Count | 5 |
Exact Mass | 393.13247072 g/mol |
Monoisotopic Mass | 393.13247072 g/mol |
Topological Polar Surface Area | 95.7 Ų |
Heavy Atom Count | 29 |
Formal Charge | 0 |
Complexity | 579 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Treatment of colorectal carcinoma
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 72015-004
Start Marketing Date : 2023-11-08
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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Registrant Name : Korea Takeda Pharmaceutical Co., Ltd.
Registration Date : 2025-03-06
Registration Number : 108-12-ND
Manufacturer Name : Tianjin Asymchem Pharmaceuticals Co., Ltd.
Manufacturer Address : No. 71, Xinye 7th Avenue, TEDA WEST Tianjin, 300462, PR
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Details:
HMPL-013 (fruquintinib) in combination with IBI308 (sintilimab) is currently being evaluated for the treatment of advanced renal cell carcinoma.
Lead Product(s): Fruquintinib,Sintilimab
Therapeutic Area: Oncology Brand Name: HMPL-013
Study Phase: Phase II/ Phase IIIProduct Type: Other Small Molecule
Sponsor: Hutchmed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 18, 2025
Lead Product(s) : Fruquintinib,Sintilimab
Therapeutic Area : Oncology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Hutchmed
Deal Size : Inapplicable
Deal Type : Inapplicable
Innovent-HUTCHMED's FRUSICA-2 Study Hits Endpoint in Renal Cancer
Details : HMPL-013 (fruquintinib) in combination with IBI308 (sintilimab) is currently being evaluated for the treatment of advanced renal cell carcinoma.
Product Name : HMPL-013
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 18, 2025
Details:
Elunate (fruquintinib) a VEGFR 1/2/3 inhibitor and Tyvyt (sintilimab) has been granted conditional approval in China for the treatment of patients with advanced endometrial cancer.
Lead Product(s): Fruquintinib,Sintilimab
Therapeutic Area: Oncology Brand Name: Elunate
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Innovent Biologics
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 03, 2024
Lead Product(s) : Fruquintinib,Sintilimab
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Innovent Biologics
Deal Size : Inapplicable
Deal Type : Inapplicable
HUTCHMED/Innovent Get China Approval for ELUNATE®/TYVYT® in Endometrial Cancer
Details : Elunate (fruquintinib) a VEGFR 1/2/3 inhibitor and Tyvyt (sintilimab) has been granted conditional approval in China for the treatment of patients with advanced endometrial cancer.
Product Name : Elunate
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 03, 2024
Details:
Fruzaqla (fruquintinib) is the first and only selective inhibitor of all three VEGF receptor kinases approved for previously treated mCRC regardless of biomarker status.
Lead Product(s): Fruquintinib
Therapeutic Area: Oncology Brand Name: Elunate
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 21, 2024
Lead Product(s) : Fruquintinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
HUTCHMED Announces Launch by Takeda of FRUZAQLA® (fruquintinib) in Japan
Details : Fruzaqla (fruquintinib) is the first and only selective inhibitor of all three VEGF receptor kinases approved for previously treated mCRC regardless of biomarker status.
Product Name : Elunate
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 21, 2024
Details:
Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau, and markets under the Fruzaqla brand name.
Lead Product(s): Fruquintinib
Therapeutic Area: Oncology Brand Name: Elunate
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Takeda Pharmaceutical
Deal Size: $1,130.0 million Upfront Cash: $400.0 million
Deal Type: Licensing Agreement October 31, 2024
Lead Product(s) : Fruquintinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Takeda Pharmaceutical
Deal Size : $1,130.0 million
Deal Type : Licensing Agreement
HUTCHMED to Receive First Commercial Milestone Payment for Fruzaqla Sales by Takeda
Details : Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau, and markets under the Fruzaqla brand name.
Product Name : Elunate
Product Type : Other Small Molecule
Upfront Cash : $400.0 million
October 31, 2024
Details:
Fruzaqla (fruquintinib) is the first and only selective inhibitor of all three VEGF receptor kinases approved for previously treated mCRC regardless of biomarker status.
Lead Product(s): Fruquintinib
Therapeutic Area: Oncology Brand Name: Fruzaqla
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 24, 2024
Lead Product(s) : Fruquintinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Takeda Receives Approval for FRUZAQLA in Japan for Advanced Colorectal Cancer
Details : Fruzaqla (fruquintinib) is the first and only selective inhibitor of all three VEGF receptor kinases approved for previously treated mCRC regardless of biomarker status.
Product Name : Fruzaqla
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 24, 2024
Details:
HMPL-013 (fruquintinib) is the first and only selective inhibitor of all three VEGF receptor kinases which is being evaluated for the treatment of gastroesophageal junction adenocarcinoma.
Lead Product(s): Fruquintinib,Paclitaxel
Therapeutic Area: Oncology Brand Name: Elunate
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 29, 2024
Lead Product(s) : Fruquintinib,Paclitaxel
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
HUTCHMED Provides Update on Fruquintinib for Second-Line Gastric Cancer in China
Details : HMPL-013 (fruquintinib) is the first and only selective inhibitor of all three VEGF receptor kinases which is being evaluated for the treatment of gastroesophageal junction adenocarcinoma.
Product Name : Elunate
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 29, 2024
Details:
Fruzaqla (fruquintinib) is the first and only selective inhibitor of all three VEGF receptor kinases approved for previously treated mCRC regardless of biomarker status.
Lead Product(s): Fruquintinib
Therapeutic Area: Oncology Brand Name: Fruzaqla
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 21, 2024
Lead Product(s) : Fruquintinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Takeda Gets EU Approval for FRUZAQLA in Metastatic Colorectal Cancer
Details : Fruzaqla (fruquintinib) is the first and only selective inhibitor of all three VEGF receptor kinases approved for previously treated mCRC regardless of biomarker status.
Product Name : Fruzaqla
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 21, 2024
Details:
Fruzaqla (fruquintinib) is a selective oral VEGFR inhibitor, playing a pivotal role in blocking tumor angiogenesis. It is being investigated in combination with sintilimab for endometrial cancer.
Lead Product(s): Fruquintinib,Sintilimab
Therapeutic Area: Oncology Brand Name: Elunate
Study Phase: Phase II/ Phase IIIProduct Type: Other Small Molecule
Sponsor: HengRui
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 13, 2024
Lead Product(s) : Fruquintinib,Sintilimab
Therapeutic Area : Oncology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : HengRui
Deal Size : Inapplicable
Deal Type : Inapplicable
HUTCHMED Initiates Phase II/III Trial of Surufatinib & Camrelizumab for Pancreatic Cancer
Details : Fruzaqla (fruquintinib) is a selective oral VEGFR inhibitor, playing a pivotal role in blocking tumor angiogenesis. It is being investigated in combination with sintilimab for endometrial cancer.
Product Name : Elunate
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 13, 2024
Details:
FRUZAQLA (fruquintinib) is the first and only selective inhibitor of all three VEGF receptor kinases approved in the U.S. for previously treated mCRC regardless of biomarker status.
Lead Product(s): Fruquintinib
Therapeutic Area: Oncology Brand Name: Fruzaqla
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 26, 2024
Lead Product(s) : Fruquintinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Takeda Receive Fruquintinib Positive CHMP Opinion for Previously Treated Colorectal Cancer
Details : FRUZAQLA (fruquintinib) is the first and only selective inhibitor of all three VEGF receptor kinases approved in the U.S. for previously treated mCRC regardless of biomarker status.
Product Name : Fruzaqla
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 26, 2024
Details:
Elunate (fruquintinib) is a selective oral inhibitor of VEGF receptors. It is approved in Hong Kong for the treatment of metastatic colorectal cancer.
Lead Product(s): Fruquintinib
Therapeutic Area: Oncology Brand Name: Elunate
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 29, 2024
Lead Product(s) : Fruquintinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
HUTCHMED Gets ELUNATE (fruquintinib) Marketing Approval in Hong Kong for Colorectal Cancer
Details : Elunate (fruquintinib) is a selective oral inhibitor of VEGF receptors. It is approved in Hong Kong for the treatment of metastatic colorectal cancer.
Product Name : Elunate
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 29, 2024
RLD : Yes
TE Code :
Brand Name : FRUZAQLA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 1MG
Approval Date : 2023-11-08
Application Number : 217564
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : FRUZAQLA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 5MG
Approval Date : 2023-11-08
Application Number : 217564
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Regulatory Info :
Registration Country : Canada
Brand Name : FRUZAQLA
Dosage Form : CAPSULE
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number : 2551454
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : FRUZAQLA
Dosage Form : CAPSULE
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number : 2551462
Regulatory Info :
Registration Country : Canada
https://www.pharmacompass.com/radio-compass-blog/fda-okays-50-new-drugs-in-2024-bms-cobenfy-lilly-s-kisunla-lead-pack-of-breakthrough-therapies
Global Sales Information
Main Therapeutic Indication : Oncology
Currency : USD
2024 Revenue in Millions : 299
2023 Revenue in Millions : 15
Growth (%) : 1,900
Patents & EXCLUSIVITIES
Patent Expiration Date : 2028-05-09
US Patent Number : 7829574
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 217564
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-05-09
Patent Expiration Date : 2028-05-09
US Patent Number : 7829574
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 217564
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-05-09
Patent Expiration Date : 2035-09-07
US Patent Number : 11046674
Drug Substance Claim :
Drug Product Claim :
Application Number : 217564
Patent Use Code : U-3753
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-09-07
Patent Expiration Date : 2035-09-07
US Patent Number : 11046674
Drug Substance Claim :
Drug Product Claim :
Application Number : 217564
Patent Use Code : U-3753
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-09-07
Patent Expiration Date : 2035-09-07
US Patent Number : 10519142
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 217564
Patent Use Code : U-3753
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-09-07
Patent Expiration Date : 2035-09-07
US Patent Number : 10519142
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 217564
Patent Use Code : U-3753
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-09-07
Patent Expiration Date : 2028-05-09
US Patent Number : 8212033
Drug Substance Claim :
Drug Product Claim :
Application Number : 217564
Patent Use Code : U-3753
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-05-09
Patent Expiration Date : 2028-05-09
US Patent Number : 8212033
Drug Substance Claim :
Drug Product Claim :
Application Number : 217564
Patent Use Code : U-3753
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-05-09
Exclusivity Code : NCE
Exclusivity Expiration Date : 2028-11-08
Application Number : 217564
Product Number : 1
Exclusivity Details :
Exclusivity Code : NCE
Exclusivity Expiration Date : 2028-11-08
Application Number : 217564
Product Number : 2
Exclusivity Details :
ABOUT THIS PAGE
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PharmaCompass offers a list of Fruquintinib 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 Fruquintinib manufacturer or Fruquintinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fruquintinib manufacturer or Fruquintinib supplier.
PharmaCompass also assists you with knowing the Fruquintinib API Price utilized in the formulation of products. Fruquintinib API Price is not always fixed or binding as the Fruquintinib Price is obtained through a variety of data sources. The Fruquintinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fruquintinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fruquintinib, including repackagers and relabelers. The FDA regulates Fruquintinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fruquintinib 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 Fruquintinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fruquintinib supplier is an individual or a company that provides Fruquintinib active pharmaceutical ingredient (API) or Fruquintinib finished formulations upon request. The Fruquintinib suppliers may include Fruquintinib API manufacturers, exporters, distributors and traders.
click here to find a list of Fruquintinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Fruquintinib Drug Master File in Korea (Fruquintinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fruquintinib. The MFDS reviews the Fruquintinib KDMF as part of the drug registration process and uses the information provided in the Fruquintinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fruquintinib 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 Fruquintinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fruquintinib suppliers with KDMF 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 Fruquintinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fruquintinib 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 Fruquintinib 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 Fruquintinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fruquintinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fruquintinib suppliers with NDC on PharmaCompass.
Fruquintinib 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 Fruquintinib 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 Fruquintinib GMP manufacturer or Fruquintinib GMP API supplier for your needs.
A Fruquintinib CoA (Certificate of Analysis) is a formal document that attests to Fruquintinib's compliance with Fruquintinib specifications and serves as a tool for batch-level quality control.
Fruquintinib CoA mostly includes findings from lab analyses of a specific batch. For each Fruquintinib 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.
Fruquintinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Fruquintinib EP), Fruquintinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fruquintinib USP).