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1. (3s)-n-(5-(2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo(1,5-a)pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide
2. Arry-470
3. Arry470
4. Bay-2757556
5. Bay2757556
6. Larotrectinib
7. Loxo-101
8. Loxo101
9. N-(5-(2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo(1,5-a)pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide
10. Vitrakvi
1. 1223405-08-0
2. Loxo-101 Sulfate
3. Arry-470 Sulfate
4. Loxo-101 (sulfate)
5. (s)-n-(5-((r)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide Sulfate
6. Rdf76r62id
7. Larotrectinib Sulfate [usan]
8. Vitrakvi
9. (3s)-n-[5-[(2r)-2-(2,5-difluorophenyl)pyrrolidin-1-yl]pyrazolo[1,5-a]pyrimidin-3-yl]-3-hydroxypyrrolidine-1-carboxamide;sulfuric Acid
10. 1-pyrrolidinecarboxamide, N-(5-((2r)-2-(2,5-difluorophenyl)-1-pyrrolidinyl)pyrazolo(1,5-a)pyrimidin-3-yl)-3-hydroxy-, (3s)-, Sulfate (1:1)
11. Vitrakvi (tn)
12. 1-pyrrolidinecarboxamide, N-[5-[(2r)-2-(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl]-3-hydroxy-, (3s)-, Sulfate (1:1)
13. Larotrectinib (loxo-101) Sulfate
14. Larotrectinib Sulphate
15. Loxo-101(sulfate)
16. Arry-470 (sulfate)
17. Unii-rdf76r62id
18. Schembl2239598
19. Chembl3989939
20. Ex-a1981a
21. Dtxsid401026485
22. Hms3886n19
23. Larotrectinib Sulfate (jan/usan)
24. Larotrectinib Sulfate [mi]
25. Larotrectinib Sulfate [jan]
26. Amy12423
27. Larotrectinib (loxo-101 Sulfate)
28. Hy-12866a
29. Mfcd29472286
30. S7960
31. Larotrectinib Sulfate [who-dd]
32. Ccg-269890
33. Cs-5314
34. Ac-30671
35. Bl161518
36. Larotrectinib Sulfate [orange Book]
37. D11138
38. (3s)-n-(5-((2r)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo(1,5-a)pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide Sulfate (1:1)
39. (s)-n-(5-((r)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide Hydrogen Sulfate
Molecular Weight | 526.5 g/mol |
---|---|
Molecular Formula | C21H24F2N6O6S |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 11 |
Rotatable Bond Count | 3 |
Exact Mass | 526.14461000 g/mol |
Monoisotopic Mass | 526.14461000 g/mol |
Topological Polar Surface Area | 169 Ų |
Heavy Atom Count | 36 |
Formal Charge | 0 |
Complexity | 741 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 2 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
Vitrakvi as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion,
- who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and
- who have no satisfactory treatment options.
L01XE53
GDUFA
DMF Review : Complete
Rev. Date : 2025-04-02
Pay. Date : 2025-03-28
DMF Number : 36785
Submission : 2022-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-07-11
Pay. Date : 2022-05-05
DMF Number : 37066
Submission : 2022-05-27
Status : Active
Type : II
NDC Package Code : 22568-1752
Start Marketing Date : 2021-06-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 17337-0324
Start Marketing Date : 2023-04-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 17337-0317
Start Marketing Date : 2022-07-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 17337-0316
Start Marketing Date : 2022-06-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
About the Company : Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutica...
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About the Company : Hope Chem is dedicated to manufacturing, marketing, and CMO service of Active Pharmaceutical Ingredients (APIs), Intermediates, and Specialty Chemicals since the year 2010. Current...
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Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Details:
Vitrakvi (larotrectinib sulfate) is an inhibitor of the TRKA, TRKB, and TRKC. It is approved for the treatment of adult and pediatric patients with ntrk gene fusion-positive solid tumors.
Lead Product(s): Larotrectinib Sulfate
Therapeutic Area: Oncology Brand Name: Vitrakvi
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 10, 2025
Lead Product(s) : Larotrectinib Sulfate
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Grants Full Approval To VITRAKVI for NTRK Fusion Solid Tumors
Details : Vitrakvi (larotrectinib sulfate) is an inhibitor of the TRKA, TRKB, and TRKC. It is approved for the treatment of adult and pediatric patients with ntrk gene fusion-positive solid tumors.
Product Name : Vitrakvi
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 10, 2025
Regulatory Info : RX
Registration Country : USA
Brand Name : VITRAKVI
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 25MG BASE
Packaging :
Approval Date : 2018-11-26
Application Number : 210861
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VITRAKVI
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 100MG BASE
Packaging :
Approval Date : 2018-11-26
Application Number : 210861
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VITRAKVI
Dosage Form : SOLUTION;ORAL
Dosage Strength : EQ 20MG BASE/ML
Packaging :
Approval Date : 2018-11-26
Application Number : 211710
Regulatory Info : RX
Registration Country : USA
RLD : Yes
TE Code :
Brand Name : VITRAKVI
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 25MG BASE
Approval Date : 2018-11-26
Application Number : 210861
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : VITRAKVI
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 100MG BASE
Approval Date : 2018-11-26
Application Number : 210861
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : VITRAKVI
Dosage Form : SOLUTION;ORAL
Dosage Strength : EQ 20MG BASE/ML
Approval Date : 2018-11-26
Application Number : 211710
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Patents & EXCLUSIVITIES
Patent Expiration Date : 2037-05-16
US Patent Number : 11337967
Drug Substance Claim :
Drug Product Claim :
Application Number : 210861
Patent Use Code : U-4123
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-05-16
Patent Expiration Date : 2029-10-21
US Patent Number : 9676783
Drug Substance Claim :
Drug Product Claim :
Application Number : 210861
Patent Use Code : U-2469
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2029-10-21
Patent Expiration Date : 2035-11-16
US Patent Number : 10172861
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 211710
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-11-16
Patent Expiration Date : 2037-04-04
US Patent Number : 10045991
Drug Substance Claim :
Drug Product Claim :
Application Number : 211710
Patent Use Code : U-2473
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-04-04
Patent Expiration Date : 2036-08-15
US Patent Number : 10799505
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 210861
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2036-08-15
Patent Expiration Date : 2037-05-16
US Patent Number : 11974998
Drug Substance Claim :
Drug Product Claim :
Application Number : 211710
Patent Use Code : U-4124
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-05-16
Patent Expiration Date : 2035-11-16
US Patent Number : 10285993
Drug Substance Claim :
Drug Product Claim :
Application Number : 210861
Patent Use Code : U-2470
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-11-16
Patent Expiration Date : 2029-10-21
US Patent Number : 9127013
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 211710
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2029-10-21
Patent Expiration Date : 2035-11-16
US Patent Number : 9782414
Drug Substance Claim :
Drug Product Claim :
Application Number : 211710
Patent Use Code : U-2471
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-11-16
Patent Expiration Date : 2029-12-23
US Patent Number : 8513263
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 211710
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2029-12-23
Exclusivity Code : ODE-215
Exclusivity Expiration Date : 2025-11-26
Application Number : 210861
Product Number : 1
Exclusivity Details :
Exclusivity Code : ODE-220
Exclusivity Expiration Date : 2025-11-26
Application Number : 210861
Product Number : 1
Exclusivity Details :
Exclusivity Code : ODE-221
Exclusivity Expiration Date : 2025-11-26
Application Number : 210861
Product Number : 1
Exclusivity Details :
Exclusivity Code : ODE-215
Exclusivity Expiration Date : 2025-11-26
Application Number : 210861
Product Number : 2
Exclusivity Details :
Exclusivity Code : ODE-220
Exclusivity Expiration Date : 2025-11-26
Application Number : 210861
Product Number : 2
Exclusivity Details :
Exclusivity Code : ODE-221
Exclusivity Expiration Date : 2025-11-26
Application Number : 210861
Product Number : 2
Exclusivity Details :
Exclusivity Code : ODE-215
Exclusivity Expiration Date : 2025-11-26
Application Number : 211710
Product Number : 1
Exclusivity Details :
Exclusivity Code : ODE-220
Exclusivity Expiration Date : 2025-11-26
Application Number : 211710
Product Number : 1
Exclusivity Details :
Exclusivity Code : ODE-221
Exclusivity Expiration Date : 2025-11-26
Application Number : 211710
Product Number : 1
Exclusivity Details :
ABOUT THIS PAGE
59
PharmaCompass offers a list of Larotrectinib Sulfate 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 Larotrectinib Sulfate manufacturer or Larotrectinib Sulfate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Larotrectinib Sulfate manufacturer or Larotrectinib Sulfate supplier.
PharmaCompass also assists you with knowing the Larotrectinib Sulfate API Price utilized in the formulation of products. Larotrectinib Sulfate API Price is not always fixed or binding as the Larotrectinib Sulfate Price is obtained through a variety of data sources. The Larotrectinib Sulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Larotrectinib Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Larotrectinib Sulfate, including repackagers and relabelers. The FDA regulates Larotrectinib Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Larotrectinib Sulfate 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 Larotrectinib Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Larotrectinib Sulfate supplier is an individual or a company that provides Larotrectinib Sulfate active pharmaceutical ingredient (API) or Larotrectinib Sulfate finished formulations upon request. The Larotrectinib Sulfate suppliers may include Larotrectinib Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Larotrectinib Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Larotrectinib Sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Larotrectinib Sulfate active pharmaceutical ingredient (API) in detail. Different forms of Larotrectinib Sulfate DMFs exist exist since differing nations have different regulations, such as Larotrectinib Sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Larotrectinib Sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Larotrectinib Sulfate USDMF includes data on Larotrectinib Sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Larotrectinib Sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Larotrectinib Sulfate suppliers with USDMF 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 Larotrectinib Sulfate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Larotrectinib Sulfate 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 Larotrectinib Sulfate 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 Larotrectinib Sulfate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Larotrectinib Sulfate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Larotrectinib Sulfate suppliers with NDC on PharmaCompass.
Larotrectinib Sulfate 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 Larotrectinib Sulfate 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 Larotrectinib Sulfate GMP manufacturer or Larotrectinib Sulfate GMP API supplier for your needs.
A Larotrectinib Sulfate CoA (Certificate of Analysis) is a formal document that attests to Larotrectinib Sulfate's compliance with Larotrectinib Sulfate specifications and serves as a tool for batch-level quality control.
Larotrectinib Sulfate CoA mostly includes findings from lab analyses of a specific batch. For each Larotrectinib Sulfate 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.
Larotrectinib Sulfate may be tested according to a variety of international standards, such as European Pharmacopoeia (Larotrectinib Sulfate EP), Larotrectinib Sulfate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Larotrectinib Sulfate USP).