Ponatinib | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Ponatinib
FDA Orange Book

Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

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xyz-pharma-m-2025-01-06

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LEBSA- Your strategic API source for niche molecules.

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Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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xyz-pharma-m-2025-01-06

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Ponatinib

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

10 API Suppliers, 3 USDMF, 2 EU WC, 4 NDC API, 7 Listed Suppliers, $ API Reference Price

10 API Suppliers
3 USDMF
2 EU WC
4 NDC API
7 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

23 FDF Dossiers, 6 FDA Orange Book, 10 Europe, 1 Canada, 6 Australia

23 FDF Dossiers
6 FDA Orange Book
10 Europe
1 Canada
6 Australia

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 15MG BASE, TABLET;ORAL - EQ 30MG BASE, TABLET;ORAL - EQ 45MG BASE

TABLET;ORAL - EQ 10MG BASE
TABLET;ORAL - EQ 15MG BASE
TABLET;ORAL - EQ 30MG BASE
TABLET;ORAL - EQ 45MG BASE

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 1 DKSH, 2 Faran Shimi Pharmaceutical, 8 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 DFE Pharma, 4 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 17 Kerry, 9 Microlex e.U, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 2 Prachin Chemical, 7 Roquette, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 2 Vasa Pharmachem

1 SPI Pharma
1 DKSH
2 Faran Shimi Pharmaceutical
8 Gangwal Healthcare
1 Nanjing Well Pharmaceutical
3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
4 DFE Pharma
4 Gangwal Chemicals
1 Ideal Cures Pvt Ltd
17 Kerry
9 Microlex e.U
1 Pharmatrans-Sanaq
2 Pluviaendo
2 Prachin Chemical
7 Roquette
2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
9 Sigachi Industries
2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

39 Fillers, Diluents & Binders, 18 Direct Compression, 11 Lubricants & Glidants, 11 Co-Processed Excipients, 11 Thickeners and Stabilizers, 8 Granulation, 5 Disintegrants & Superdisintegrants, 4 Controlled & Modified Release, 3 Emulsifying Agents, 2 Chewable & Orodispersible Aids, 2 Coating Systems & Additives, 2 Taste Masking, 1 Rheology Modifiers, 1 Parenteral, 1 Film Formers & Plasticizers, 1 API Stability Enhancers

39 Fillers, Diluents & Binders
18 Direct Compression
11 Lubricants & Glidants
11 Co-Processed Excipients
11 Thickeners and Stabilizers
8 Granulation
5 Disintegrants & Superdisintegrants
4 Controlled & Modified Release
3 Emulsifying Agents
2 Chewable & Orodispersible Aids
2 Coating Systems & Additives
2 Taste Masking
1 Rheology Modifiers
1 Parenteral
1 Film Formers & Plasticizers
1 API Stability Enhancers

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 1 STOCK RECAP #PipelineProspector, 35 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
1 STOCK RECAP #PipelineProspector
35 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 7 Finished Drug Prices, 8 Annual Reports

1 US Medicaid Prescriptions
7 Finished Drug Prices
8 Annual Reports

MARKET PLACE

4 APIs, 2 FDF Dossiers

4 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

68 US Patents, 8 US Exclusivities, 2 Health Canada Patents

68 US Patents
8 US Exclusivities
2 Health Canada Patents

$ API Ref.Price (USD/KG) : 84,930 Xls

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01 2APOTEX

02 4TAKEDA PHARMS USA

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01 6TABLET;ORAL

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01 2DISCN

02 4RX

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01 4ICLUSIG

02 2PONATINIB HYDROCHLORIDE

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01 2No

02 4Yes

List of Suppliers

Product Main Page

01

APOTEX

Pharmatech Expo 2025

Not Confirmed

APOTEX

Pharmatech Expo 2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

RLD : No

TE Code :

PONATINIB HYDROCHLORIDE

Brand Name : PONATINIB HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 15MG BASE

Approval Date : 2023-07-14

Application Number : 215893

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

APOTEX

Pharmatech Expo 2025

Not Confirmed

APOTEX

Pharmatech Expo 2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

RLD : No

TE Code :

PONATINIB HYDROCHLORIDE

Brand Name : PONATINIB HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 45MG BASE

Approval Date : 2023-07-14

Application Number : 215893

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

TAKEDA PHARMS USA

Pharmatech Expo 2025

Not Confirmed

TAKEDA PHARMS USA

Pharmatech Expo 2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

RLD : Yes

TE Code :

PONATINIB HYDROCHLORIDE

Brand Name : ICLUSIG

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 15MG BASE

Approval Date : 2012-12-14

Application Number : 203469

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

04

TAKEDA PHARMS USA

Pharmatech Expo 2025

Not Confirmed

TAKEDA PHARMS USA

Pharmatech Expo 2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

RLD : Yes

TE Code :

PONATINIB HYDROCHLORIDE

Brand Name : ICLUSIG

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 45MG BASE

Approval Date : 2012-12-14

Application Number : 203469

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

05

TAKEDA PHARMS USA

Pharmatech Expo 2025

Not Confirmed

TAKEDA PHARMS USA

Pharmatech Expo 2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

RLD : Yes

TE Code :

PONATINIB HYDROCHLORIDE

Brand Name : ICLUSIG

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 30MG BASE

Approval Date : 2015-04-23

Application Number : 203469

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

06

TAKEDA PHARMS USA

Pharmatech Expo 2025

Not Confirmed

TAKEDA PHARMS USA

Pharmatech Expo 2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

RLD : Yes

TE Code :

PONATINIB HYDROCHLORIDE

Brand Name : ICLUSIG

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 2020-12-18

Application Number : 203469

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

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