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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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USDMF

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CEP/COS

CEP/COS Certifications

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JDMF

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EU WC

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KDMF

KDMF

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VMF

NDC API

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Listed Suppliers

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0INTERMEDIATES

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USP

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JP

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Chemistry

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Also known as: Ds-6051b, 1505515-69-4, Taletrectinib adipate, Ds-6051b adipate, 6kll51gnbg, Taletrectinib adipate [usan]
Molecular Formula
C29H34FN5O5
Molecular Weight
551.6  g/mol
InChI Key
DORJQZDOULKINH-QNBGGDODSA-N
FDA UNII
6KLL51GNBG

Taletrectinib
Taletrectinib Adipate is the adiptate form of taletrectinib, a n orally available inhibitor of the receptor tyrosine kinases C-ros oncogene 1 (ROS1) and the neurotrophic tyrosine receptor kinase (NTRK) types 1, 2 and 3, with potential antineoplastic activity. Upon oral administration, taletrectinib binds to and inhibits ROS1 and the NTRK family members. This inhibition leads to a disruption of ROS1- and NTRK-mediated signaling and eventually inhibits the growth of tumor cells that are overexpressing ROS1 and/or NTRKs. ROS1, overexpressed in certain cancer cells, plays a key role in cell growth and survival of cancer cells. NTRK mutations or rearrangements play a key role in cancer progression.
1 2D Structure

Taletrectinib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
3-[4-[(2R)-2-aminopropoxy]phenyl]-N-[(1R)-1-(3-fluorophenyl)ethyl]imidazo[1,2-b]pyridazin-6-amine;hexanedioic acid
2.1.2 InChI
InChI=1S/C23H24FN5O.C6H10O4/c1-15(25)14-30-20-8-6-17(7-9-20)21-13-26-23-11-10-22(28-29(21)23)27-16(2)18-4-3-5-19(24)12-18;7-5(8)3-1-2-4-6(9)10/h3-13,15-16H,14,25H2,1-2H3,(H,27,28);1-4H2,(H,7,8)(H,9,10)/t15-,16-;/m1./s1
2.1.3 InChI Key
DORJQZDOULKINH-QNBGGDODSA-N
2.1.4 Canonical SMILES
CC(COC1=CC=C(C=C1)C2=CN=C3N2N=C(C=C3)NC(C)C4=CC(=CC=C4)F)N.C(CCC(=O)O)CC(=O)O
2.1.5 Isomeric SMILES
C[C@H](COC1=CC=C(C=C1)C2=CN=C3N2N=C(C=C3)N[C@H](C)C4=CC(=CC=C4)F)N.C(CCC(=O)O)CC(=O)O
2.2 Other Identifiers
2.2.1 UNII
6KLL51GNBG
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 3-(4-((2r)-2-aminopropoxy)phenyl)-n-((1r)-1-(3-fluorophenyl)ethyl)imidazo(1,2-b)pyridazin-6-amine;hexanedioic Acid

2.3.2 Depositor-Supplied Synonyms

1. Ds-6051b

2. 1505515-69-4

3. Taletrectinib Adipate

4. Ds-6051b Adipate

5. 6kll51gnbg

6. Taletrectinib Adipate [usan]

7. 1505515-69-4 (adipate)

8. 3-(4-((r)-2-aminopropoxy)phenyl)-n-((r)-1-(3-fluorophenyl)ethyl)imidazo[1,2-b]pyridazin-6-amine Adipate

9. 3-[4-[((2r)-2-aminopropyl)oxy]phenyl]-n-[(1r)-1-(3-fluorophenyl)ethyl]imidazo[1,2-b]pyridazin-6-amine Monoadipate

10. 3-[4-[(2r)-2-aminopropoxy]phenyl]-n-[(1r)-1-(3-fluorophenyl)ethyl]imidazo[1,2-b]pyridazin-6-amine;hexanedioic Acid

11. Unii-6kll51gnbg

12. Ab-106 Adipate

13. Chembl4650361

14. Schembl16468541

15. Glxc-25968

16. Ex-a4255

17. S8901

18. Ac-36532

19. Hy-131003

20. Cs-0120270

21. F78020

22. 3-(4-((r)-2-aminopropoxy)phenyl)-n-((r)-1-(3-fluorophenyl)ethyl)imidazo[1,2-b]pyridazin-6-amine (1:1)

23. 8-trifluoromethyl-3-cyclopropylmethyl-7-[(4-(2,4-difluorophenyl)-1-piperazinyl)methyl]-1,2,4-triazolo[4,3-a]pyridine

24. Hexanedioic Acid, Compd. With 3-[4-[(2r)-2-aminopropoxy]phenyl]-n-[(1r)-1-(3-fluorophenyl)ethyl]imidazo[1,2-b]pyridazin-6-amine (1:1)

2.4 Create Date
2014-01-13
3 Chemical and Physical Properties
Molecular Weight 551.6 g/mol
Molecular Formula C29H34FN5O5
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count10
Rotatable Bond Count12
Exact Mass551.25439736 g/mol
Monoisotopic Mass551.25439736 g/mol
Topological Polar Surface Area152 Ų
Heavy Atom Count40
Formal Charge0
Complexity645
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2

API SUPPLIERS

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01

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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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USDMF CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
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NDC API

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Asymchem Laboratories (Tianjin) Co....

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Asymchem Laboratories (Tianjin) Co....

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TALETRECTINIB ADIPATE

NDC Package Code : 72015-007

Start Marketing Date : 2025-06-13

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Drugs in Development

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Details:

Taletrectinib is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.


Lead Product(s): Taletrectinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 04, 2025

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01

Nuvation Bio

U.S.A
arrow
COMPAMED
Not Confirmed

Nuvation Bio

U.S.A
arrow
COMPAMED
Not Confirmed

Details : Taletrectinib is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

September 04, 2025

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Details:

Ibtrozi (taletrectinib) is an inhibitor of tyrosine kinase ROS1. It is approved for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.


Lead Product(s): Taletrectinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Ibtrozi

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 11, 2025

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02

Nuvation Bio

U.S.A
arrow
COMPAMED
Not Confirmed

Nuvation Bio

U.S.A
arrow
COMPAMED
Not Confirmed

Details : Ibtrozi (taletrectinib) is an inhibitor of tyrosine kinase ROS1. It is approved for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.

Product Name : Ibtrozi

Product Type : Miscellaneous

Upfront Cash : Inapplicable

June 11, 2025

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Details:

The financing is intended to support the clinical development and commercialization of AB-106 (taletrectinib), in the U.S. Currently, it is being evaluated for the treatment of ROS1-positive NSCLC.


Lead Product(s): Taletrectinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Sagard Healthcare Partners

Deal Size: $250.0 million Upfront Cash: Undisclosed

Deal Type: Financing March 03, 2025

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03

Nuvation Bio

U.S.A
arrow
COMPAMED
Not Confirmed

Nuvation Bio

U.S.A
arrow
COMPAMED
Not Confirmed

Lead Product(s) : Taletrectinib,Inapplicable

Therapeutic Area : Oncology

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : Sagard Healthcare Partners

Deal Size : $250.0 million

Deal Type : Financing

Details : The financing is intended to support the clinical development and commercialization of AB-106 (taletrectinib), in the U.S. Currently, it is being evaluated for the treatment of ROS1-positive NSCLC.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Undisclosed

March 03, 2025

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Details:

Taletrectinib is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Lung Neoplasms.


Lead Product(s): Taletrectinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: UndisclosedProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 24, 2025

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04

Nuvation Bio

U.S.A
arrow
COMPAMED
Not Confirmed

Nuvation Bio

U.S.A
arrow
COMPAMED
Not Confirmed

Details : Taletrectinib is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Lung Neoplasms.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

February 24, 2025

blank

Details:

AB-106 (taletrectinib adipate) is a next-generation ROS1 TKI, which is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC.


Lead Product(s): Taletrectinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 03, 2025

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05

Nuvation Bio

U.S.A
arrow
COMPAMED
Not Confirmed

Nuvation Bio

U.S.A
arrow
COMPAMED
Not Confirmed

Details : AB-106 (taletrectinib adipate) is a next-generation ROS1 TKI, which is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

February 03, 2025

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Details:

Dovbleron (taletrectinib) is a next-generation ROS1 TKI, which is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC.


Lead Product(s): Taletrectinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Dovbleron

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 06, 2025

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06

Nuvation Bio

U.S.A
arrow
COMPAMED
Not Confirmed

Nuvation Bio

U.S.A
arrow
COMPAMED
Not Confirmed

Details : Dovbleron (taletrectinib) is a next-generation ROS1 TKI, which is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC.

Product Name : Dovbleron

Product Type : Miscellaneous

Upfront Cash : Inapplicable

January 06, 2025

blank

Details:

AB-106 (taletrectinib) is a next-generation ROS1 TKI, which is being evaluated for the treatment of adult patients with locally advanced or metastatic NSCLC.


Lead Product(s): Taletrectinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 23, 2024

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07

Nuvation Bio

U.S.A
arrow
COMPAMED
Not Confirmed

Nuvation Bio

U.S.A
arrow
COMPAMED
Not Confirmed

Details : AB-106 (taletrectinib) is a next-generation ROS1 TKI, which is being evaluated for the treatment of adult patients with locally advanced or metastatic NSCLC.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 23, 2024

blank

Details:

Dovbleron (taletrectinib) is a next-generation ROS1 TKI, indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer.


Lead Product(s): Taletrectinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Dovbleron

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 20, 2024

blank

08

COMPAMED
Not Confirmed
COMPAMED
Not Confirmed

Details : Dovbleron (taletrectinib) is a next-generation ROS1 TKI, indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer.

Product Name : Dovbleron

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 20, 2024

blank

Details:

AB-106 (taletrectinib) is a next-generation ROS1 TKI, which is being evaluated for the treatment of adult patients with locally advanced or metastatic NSCLC.


Lead Product(s): Taletrectinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 14, 2024

blank

09

Nuvation Bio

U.S.A
arrow
COMPAMED
Not Confirmed

Nuvation Bio

U.S.A
arrow
COMPAMED
Not Confirmed

Details : AB-106 (taletrectinib) is a next-generation ROS1 TKI, which is being evaluated for the treatment of adult patients with locally advanced or metastatic NSCLC.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

September 14, 2024

blank

Details:

Taletrectinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.


Lead Product(s): Taletrectinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: AnHeart Therapeutics

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 21, 2024

blank

10

Nuvation Bio

U.S.A
arrow
COMPAMED
Not Confirmed

Nuvation Bio

U.S.A
arrow
COMPAMED
Not Confirmed

Details : Taletrectinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 21, 2024

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ABOUT THIS PAGE

Looking for 1505515-69-4 / Taletrectinib API manufacturers, exporters & distributors?

Taletrectinib manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Taletrectinib 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 Taletrectinib manufacturer or Taletrectinib supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Taletrectinib manufacturer or Taletrectinib supplier.

PharmaCompass also assists you with knowing the Taletrectinib API Price utilized in the formulation of products. Taletrectinib API Price is not always fixed or binding as the Taletrectinib Price is obtained through a variety of data sources. The Taletrectinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Taletrectinib

Synonyms

Ds-6051b, 1505515-69-4, Taletrectinib adipate, Ds-6051b adipate, 6kll51gnbg, Taletrectinib adipate [usan]

Cas Number

1505515-69-4

Unique Ingredient Identifier (UNII)

6KLL51GNBG

About Taletrectinib

Taletrectinib Adipate is the adiptate form of taletrectinib, a n orally available inhibitor of the receptor tyrosine kinases C-ros oncogene 1 (ROS1) and the neurotrophic tyrosine receptor kinase (NTRK) types 1, 2 and 3, with potential antineoplastic activity. Upon oral administration, taletrectinib binds to and inhibits ROS1 and the NTRK family members. This inhibition leads to a disruption of ROS1- and NTRK-mediated signaling and eventually inhibits the growth of tumor cells that are overexpressing ROS1 and/or NTRKs. ROS1, overexpressed in certain cancer cells, plays a key role in cell growth and survival of cancer cells. NTRK mutations or rearrangements play a key role in cancer progression.

Taletrectinib Manufacturers

A Taletrectinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Taletrectinib, including repackagers and relabelers. The FDA regulates Taletrectinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Taletrectinib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Taletrectinib Suppliers

A Taletrectinib supplier is an individual or a company that provides Taletrectinib active pharmaceutical ingredient (API) or Taletrectinib finished formulations upon request. The Taletrectinib suppliers may include Taletrectinib API manufacturers, exporters, distributors and traders.

click here to find a list of Taletrectinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Taletrectinib 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 Taletrectinib as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Taletrectinib 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 Taletrectinib 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 Taletrectinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Taletrectinib NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Taletrectinib suppliers with NDC on PharmaCompass.

Taletrectinib GMP

Taletrectinib 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 Taletrectinib 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 Taletrectinib GMP manufacturer or Taletrectinib GMP API supplier for your needs.

Taletrectinib CoA

A Taletrectinib CoA (Certificate of Analysis) is a formal document that attests to Taletrectinib's compliance with Taletrectinib specifications and serves as a tool for batch-level quality control.

Taletrectinib CoA mostly includes findings from lab analyses of a specific batch. For each Taletrectinib 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.

Taletrectinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Taletrectinib EP), Taletrectinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Taletrectinib 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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