Find Talazoparib manufacturers, exporters & distributors on PharmaCompass

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ACTIVE PHARMA INGREDIENTS

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Chemistry

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Also known as:
Molecular Formula
C19H14F2N6O
Molecular Weight
380.4  g/mol
InChI Key
IUEWAGVJRJORLA-HZPDHXFCSA-N

Talazoparib
1 2D Structure

Talazoparib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(11S,12R)-7-fluoro-11-(4-fluorophenyl)-12-(2-methyl-1,2,4-triazol-3-yl)-2,3,10-triazatricyclo[7.3.1.05,13]trideca-1(13),5,7,9-tetraen-4-one
2.1.2 InChI
InChI=1S/C19H14F2N6O/c1-27-18(22-8-23-27)15-16(9-2-4-10(20)5-3-9)24-13-7-11(21)6-12-14(13)17(15)25-26-19(12)28/h2-8,15-16,25H,1H3,(H,26,28)/t15-,16-/m1/s1
2.1.3 InChI Key
IUEWAGVJRJORLA-HZPDHXFCSA-N
2.1.4 Canonical SMILES
CN1C(=NC=N1)C2C(N=C3C=C(C=C4C3=C2NNC4=O)F)C5=CC=C(C=C5)F
2.1.5 Isomeric SMILES
CN1C(=NC=N1)[C@@H]2[C@H](N=C3C=C(C=C4C3=C2NNC4=O)F)C5=CC=C(C=C5)F
2.2 Create Date
2010-03-15
3 Chemical and Physical Properties
Molecular Weight 380.4 g/mol
Molecular Formula C19H14F2N6O
XLogP31.4
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count7
Rotatable Bond Count2
Exact Mass380.11971542 g/mol
Monoisotopic Mass380.11971542 g/mol
Topological Polar Surface Area84.2 A^2
Heavy Atom Count28
Formal Charge0
Complexity826
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

NDC API

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TALAZOPARIB

NDC Package Code : 46014-1140

Start Marketing Date : 2018-10-01

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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Talazoparib

About the Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and chemical products, cat...

Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and chemical products, catering to both export and import markets. The company consists of two primary business departments: the Professional Sourcing/Product Team and the Quality Team. Backed by experienced partners, Longshine has evolved into a trustworthy supplier of high-quality products and received ISO9001:2008 certification in 2017.
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Drugs in Development

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Details:

Talzenna (talazoparib), an oral PARP inhibitor in combination with Xtandi (enzalutamide) is approved for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC).


Lead Product(s): Talazoparib,Enzalutamide

Therapeutic Area: Oncology Brand Name: Talzenna

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 13, 2025

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Pfizer Inc

U.S.A
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IFT FIRST
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Pfizer Inc

U.S.A
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IFT FIRST
Not Confirmed

Details : Talzenna (talazoparib), an oral PARP inhibitor in combination with Xtandi (enzalutamide) is approved for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC).

Product Name : Talzenna

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

February 13, 2025

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Details:

Talzenna (talazoparib) combined with Xtandi (enzalutamide) is approved by EMA for treating metastatic castration-resistant prostate cancer (mCRPC).


Lead Product(s): Talazoparib,Enzalutamide

Therapeutic Area: Oncology Brand Name: Talzenna

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 01, 2024

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Pfizer Inc

U.S.A
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IFT FIRST
Not Confirmed

Pfizer Inc

U.S.A
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IFT FIRST
Not Confirmed

Details : Talzenna (talazoparib) combined with Xtandi (enzalutamide) is approved by EMA for treating metastatic castration-resistant prostate cancer (mCRPC).

Product Name : Talzenna

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

August 01, 2024

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Details:

Talzenna (talazoparib) is a PARP inhibitor, which is approved for the treatment of BRCA gene mutation-positive castration-resistant prostate cancer with distant metastases.


Lead Product(s): Talazoparib

Therapeutic Area: Oncology Brand Name: Talzenna

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 02, 2024

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Details : Talzenna (talazoparib) is a PARP inhibitor, which is approved for the treatment of BRCA gene mutation-positive castration-resistant prostate cancer with distant metastases.

Product Name : Talzenna

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

May 02, 2024

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Details:

Talzenna (talazoparib) is an oral inhibitor of PARP, which plays a role in DNA damage repair combination with XTANDI (enzalutamide) for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).


Lead Product(s): Talazoparib,Enzalutamide

Therapeutic Area: Oncology Brand Name: Talzenna

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: TFS Trial Form Support

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 20, 2023

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Pfizer Inc

U.S.A
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IFT FIRST
Not Confirmed

Pfizer Inc

U.S.A
arrow
IFT FIRST
Not Confirmed

Details : Talzenna (talazoparib) is an oral inhibitor of PARP, which plays a role in DNA damage repair combination with XTANDI (enzalutamide) for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistan...

Product Name : Talzenna

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

June 20, 2023

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Details:

Talzenna (talazoparib) is an oral PARP inhibitor, which plays a role in DNA damage repair. Preclinical studies have demonstrated that TALZENNA blocks PARP enzyme activity and traps PARP at the site of DNA damage, leading to cancer cell apoptosis.


Lead Product(s): Talazoparib,Enzalutamide

Therapeutic Area: Oncology Brand Name: Talzenna

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 16, 2023

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Pfizer Inc

U.S.A
arrow
IFT FIRST
Not Confirmed

Pfizer Inc

U.S.A
arrow
IFT FIRST
Not Confirmed

Details : Talzenna (talazoparib) is an oral PARP inhibitor, which plays a role in DNA damage repair. Preclinical studies have demonstrated that TALZENNA blocks PARP enzyme activity and traps PARP at the site of DNA damage, leading to cancer cell apoptosis.

Product Name : Talzenna

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

February 16, 2023

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Details:

CX-5461 (pidnarulex) stabilizes the DNA G-quadruplexes of cancer cells which leads to disruption of the cell's replication fork. Pidnarulex demonstrated clinically significant and lasting benefits in patients with specific tumor biomarkers, such as BRCA1/2 and PALB2 mutations.


Lead Product(s): Pidnarulex,Talazoparib

Therapeutic Area: Oncology Brand Name: CX-5461

Study Phase: Phase IProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 31, 2022

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Details : CX-5461 (pidnarulex) stabilizes the DNA G-quadruplexes of cancer cells which leads to disruption of the cell's replication fork. Pidnarulex demonstrated clinically significant and lasting benefits in patients with specific tumor biomarkers, such as BRCA1...

Product Name : CX-5461

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

October 31, 2022

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Details:

ART4215 is first selective, oral, small molecule inhibitor of Polθ polymerase domain to enter clinic. Polθ, a DNA polymerase, is a tumor-specific DDR target involved in MMEJ that is overexpressed in many tumors and found in low levels in healthy tissue.


Lead Product(s): ART4215,Talazoparib

Therapeutic Area: Oncology Brand Name: ART4215

Study Phase: Phase IIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 08, 2022

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Artios Pharma Limited

United Kingdom
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Artios Pharma Limited

United Kingdom
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Not Confirmed

Details : ART4215 is first selective, oral, small molecule inhibitor of Polθ polymerase domain to enter clinic. Polθ, a DNA polymerase, is a tumor-specific DDR target involved in MMEJ that is overexpressed in many tumors and found in low levels in healthy tissue...

Product Name : ART4215

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

October 08, 2022

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Details:

The data from the Phase 1b/2 trial has shown that the ZEN003694 (ZEN-3694) plus talazoparib combination regimen induced durable responses in tumors of TNBC patients which do not harbor mutations in BRCA1/2.


Lead Product(s): ZEN-3694,Talazoparib

Therapeutic Area: Oncology Brand Name: ZEN-3694

Study Phase: Phase IIProduct Type: Other Small Molecule

Sponsor: Pfizer Inc

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 05, 2022

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Details : The data from the Phase 1b/2 trial has shown that the ZEN003694 (ZEN-3694) plus talazoparib combination regimen induced durable responses in tumors of TNBC patients which do not harbor mutations in BRCA1/2.

Product Name : ZEN-3694

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

October 05, 2022

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Details:

RP-3500 is a potent and selective oral small molecule inhibitor of ATR being developed for treatment of solid tumors with specific genome instability related genomic alterations including those in the ATM (ataxia-telangiectasia mutated) gene.


Lead Product(s): Camonsertib,Gemcitabine,Talazoparib

Therapeutic Area: Oncology Brand Name: RP-3500

Study Phase: Phase I/ Phase IIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 04, 2022

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Details : RP-3500 is a potent and selective oral small molecule inhibitor of ATR being developed for treatment of solid tumors with specific genome instability related genomic alterations including those in the ATM (ataxia-telangiectasia mutated) gene.

Product Name : RP-3500

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

August 04, 2022

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Details:

RP-3500, orally-administered ataxia telangiectasia and Rad3-related inhibitor currently in Phase 1/2 TRESR trial clinical development in patients with DNA damage repair, loss-of-function and mutant tumors.


Lead Product(s): Camonsertib,Gemcitabine,Talazoparib

Therapeutic Area: Oncology Brand Name: RP-3500

Study Phase: Phase I/ Phase IIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 03, 2022

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IFT FIRST
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IFT FIRST
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Details : RP-3500, orally-administered ataxia telangiectasia and Rad3-related inhibitor currently in Phase 1/2 TRESR trial clinical development in patients with DNA damage repair, loss-of-function and mutant tumors.

Product Name : RP-3500

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

August 03, 2022

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Europe

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Talazoparibtosylat

Brand Name : Talzenna

Dosage Form : Kapsel, hard

Dosage Strength : 0.1 mg

Packaging : Boks 30item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Pfizer AG

U.S.A
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Pfizer AG

U.S.A
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Talazoparibum

Brand Name : Talzenna

Dosage Form : Caps

Dosage Strength : 0.25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Pfizer AG

U.S.A
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Pfizer AG

U.S.A
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Talazoparibum

Brand Name : Talzenna

Dosage Form : Caps

Dosage Strength : 1mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Australia

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Talazoparib

Brand Name : Talzenna

Dosage Form :

Dosage Strength :

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Talazoparib

Brand Name : Talzenna

Dosage Form :

Dosage Strength :

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Talazoparib

Brand Name : Talzenna

Dosage Form :

Dosage Strength :

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Talazoparib

Brand Name : Talzenna

Dosage Form :

Dosage Strength :

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Looking for / Talazoparib API manufacturers, exporters & distributors?

Talazoparib manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Talazoparib

Talazoparib Manufacturers

A Talazoparib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Talazoparib, including repackagers and relabelers. The FDA regulates Talazoparib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Talazoparib 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 Talazoparib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Talazoparib Suppliers

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

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

Talazoparib 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 Talazoparib as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Talazoparib GMP

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

Talazoparib CoA

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

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

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