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Acalabrutinib
FDF Dossiers

AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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pharmacompass-1-m-2026-01-12

Evonik Health Care is the innovation hub for leading life science companies

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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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pharmacompass-2-2026-02-09

Acalabrutinib

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

18 API Suppliers, 7 USDMF, 3 EU WC, 2 KDMF, 7 NDC API, 11 Listed Suppliers, $ API Reference Price

18 API Suppliers
7 USDMF
3 EU WC
2 KDMF
7 NDC API
11 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

112 Drugs in Development

112 Drugs in Development

INTERMEDIATES

23 Intermediate Suppliers

23 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

27 FDF Dossiers, 4 FDA Orange Book, 14 Europe, 1 Canada, 4 Australia, 1 South Africa, 3 Listed Dossiers

27 FDF Dossiers
4 FDA Orange Book
14 Europe
1 Canada
4 Australia
1 South Africa
3 Listed Dossiers

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 4 Gangwal Healthcare, 4 ACG Worldwide, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 DFE Pharma, 5 Gangwal Chemicals, 1 Ideal Cures, 3 Ingredion Pharma Solutions, 1 Kerry, 2 Keval Exports, 3 Lonza Capsugel, 7 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Pharmatrans-Sanaq, 2 Pluviaendo, 3 Prachin Chemical, 1 Qualicaps, 17 Roquette, 1 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 3 Silverline Chemicals, 3 Vasa Pharmachem

4 SPI Pharma
4 Gangwal Healthcare
4 ACG Worldwide
5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
3 DFE Pharma
5 Gangwal Chemicals
1 Ideal Cures
3 Ingredion Pharma Solutions
1 Kerry
2 Keval Exports
3 Lonza Capsugel
7 Microlex e.U
2 Nitika Pharmaceutical Specialities
2 Pharmatrans-Sanaq
2 Pluviaendo
3 Prachin Chemical
1 Qualicaps
17 Roquette
1 Seppic
3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
9 Sigachi Industries
3 Silverline Chemicals
3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

30 Fillers, Diluents & Binders, 16 Disintegrants & Superdisintegrants, 12 Direct Compression, 11 Thickeners and Stabilizers, 11 Lubricants & Glidants, 10 Co-Processed Excipients, 8 Empty Capsules, 7 Granulation, 6 Taste Masking, 6 Chewable & Orodispersible Aids, 5 Coating Systems & Additives, 3 Film Formers & Plasticizers, 3 Controlled & Modified Release, 2 Emulsifying Agents, 1 API Stability Enhancers, 1 Rheology Modifiers

30 Fillers, Diluents & Binders
16 Disintegrants & Superdisintegrants
12 Direct Compression
11 Thickeners and Stabilizers
11 Lubricants & Glidants
10 Co-Processed Excipients
8 Empty Capsules
7 Granulation
6 Taste Masking
6 Chewable & Orodispersible Aids
5 Coating Systems & Additives
3 Film Formers & Plasticizers
3 Controlled & Modified Release
2 Emulsifying Agents
1 API Stability Enhancers
1 Rheology Modifiers

DIGITAL CONTENT

75 News #PharmaBuzz

75 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 8 Annual Reports

2 US Medicaid Prescriptions
8 Annual Reports

MARKET PLACE

1 APIs, 1 FDF Dossiers

1 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

61 US Patents, 3 US Exclusivities, 1 Health Canada Patents

61 US Patents
3 US Exclusivities
1 Health Canada Patents

$ API Ref.Price (USD/KG) : 22,500 Xls

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25 All

01 1Alembic Pharmaceuticals Limited

02 1Aprazer

03 20AstraZeneca

04 1Genex Pharma

05 1Intas Pharmaceuticals

06 1MSN Laboratories

filter Dosage Reset all filters

25 All

01 1CAP

02 1CAPSULE

03 2CAPSULE;ORAL

04 4Capsule

05 6Film Coated Tablet

06 1Film-Coated Tablet

07 3Hard Capsule

08 1Hard Capsules

09 1TABLET

10 1TABLET;ORAL

11 4Blank

filter Regulatory Info Reset all filters

25 All

01 2Allowed

02 3Authorized

03 1Marketed

04 1Not Marketed

05 1Originator

06 5Prescription

07 2RX

08 10Blank

filter Brand Name Reset all filters

25 All

01 2ACALABRUTINIB

02 1ACALAKAST

03 7CALQUENCE

04 1CAPBRUSAM

05 12Calquence

06 1Calquence 100 mg

07 1Blank

filter Country Reset all filters

25 All

01 4Australia

02 1Canada

03 2Denmark

04 2Estonia

05 3India

06 1Moldova

07 2Norway

08 1South Africa

09 3Spain

10 2Switzerland

11 4USA

List of Suppliers

Product Main Page

01

Alembic Pharmaceuticals Limited

ASPEN

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Alembic Pharmaceuticals Limited

ASPEN

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Digital Content

Regulatory Info :

Registration Country : USA

ACALABRUTINIB

Brand Name : ACALABRUTINIB

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number : 216775

Regulatory Info :

Registration Country : USA

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Aprazer

ASPEN

Not Confirmed

Aprazer

ASPEN

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Regulatory Info :

Registration Country : India

Acalabrutinib

Brand Name : ACALAKAST

Dosage Form : Capsule

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Portfolio PDF

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Digital Content

03

AstraZeneca

ASPEN

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AstraZeneca

ASPEN

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Digital Content

Regulatory Info : RX

Registration Country : USA

ACALABRUTINIB

Brand Name : CALQUENCE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Packaging :

Approval Date : 2017-10-31

Application Number : 210259

Regulatory Info : RX

Registration Country : USA

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

AstraZeneca

ASPEN

Not Confirmed

AstraZeneca

ASPEN

Not Confirmed

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Digital Content

Regulatory Info : RX

Registration Country : USA

ACALABRUTINIB MALEATE

Brand Name : CALQUENCE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 100MG BASE

Packaging :

Approval Date : 2022-08-03

Application Number : 216387

Regulatory Info : RX

Registration Country : USA

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

AstraZeneca

ASPEN

Not Confirmed

AstraZeneca

ASPEN

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Digital Content

Regulatory Info : Allowed

Registration Country : Switzerland

Acalabrutinib

Brand Name : Calquence

Dosage Form : Hard Capsule

Dosage Strength : 100mg

Packaging :

Approval Date : 2021-03-04

Application Number : 67790

Regulatory Info : Allowed

Registration Country : Switzerland

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

AstraZeneca

ASPEN

Not Confirmed

AstraZeneca

ASPEN

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

Regulatory Info : Allowed

Registration Country : Switzerland

Acalabrutinib

Brand Name : Calquence

Dosage Form : Film Coated Tablet

Dosage Strength : 100mg

Packaging :

Approval Date : 2023-05-04

Application Number : 68817

Regulatory Info : Allowed

Registration Country : Switzerland

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

AstraZeneca

ASPEN

Not Confirmed

AstraZeneca

ASPEN

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Moldova

Acalabrutinib

Brand Name : Calquence

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 01-07-2024

Application Number :

Regulatory Info :

Registration Country : Moldova

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

AstraZeneca

ASPEN

Not Confirmed

AstraZeneca

ASPEN

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

Regulatory Info : Not Marketed

Registration Country : Norway

Akalabrutinib

Brand Name : Calquence

Dosage Form : Capsule

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

AstraZeneca

ASPEN

Not Confirmed

AstraZeneca

ASPEN

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

Regulatory Info : Marketed

Registration Country : Norway

Akalabrutinib

Brand Name : Calquence

Dosage Form : Film Coated Tablet

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

AstraZeneca

ASPEN

Not Confirmed

AstraZeneca

ASPEN

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

Regulatory Info : Prescription

Registration Country : Estonia

Acalabrutinib

Brand Name : Calquence

Dosage Form : Capsule

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

11

AstraZeneca

ASPEN

Not Confirmed

AstraZeneca

ASPEN

Not Confirmed

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Digital Content

Regulatory Info : Prescription

Registration Country : Estonia

Acalabrutinib

Brand Name : Calquence

Dosage Form : Film-Coated Tablet

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

12

AstraZeneca

ASPEN

Not Confirmed

AstraZeneca

ASPEN

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

Regulatory Info : Authorized

Registration Country : Spain

Acalabrutinib Maleate

Brand Name : Calquence

Dosage Form : Film Coated Tablet

Dosage Strength : 100MG

Packaging :

Approval Date : 21-06-2023

Application Number : 1201479004

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

13

AstraZeneca

ASPEN

Not Confirmed

AstraZeneca

ASPEN

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Acalabrutinib

Brand Name : Calquence

Dosage Form : Hard Capsule

Dosage Strength : 100MG

Packaging :

Approval Date : 18-11-2020

Application Number : 1201479002

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

14

AstraZeneca

ASPEN

Not Confirmed

AstraZeneca

ASPEN

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Acalabrutinib Maleate

Brand Name : Calquence

Dosage Form : Film Coated Tablet

Dosage Strength : 100MG

Packaging :

Approval Date : 09-09-2025

Application Number : 1201479004IP

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

15

AstraZeneca

ASPEN

Not Confirmed

AstraZeneca

ASPEN

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Regulatory Info : Prescription

Registration Country : Canada

ACALABRUTINIB (ACALABRUTINIB MALEATE)

Brand Name : CALQUENCE

Dosage Form : TABLET

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number : 2535696

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

16

AstraZeneca

ASPEN

Not Confirmed

AstraZeneca

ASPEN

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Regulatory Info : Originator

Registration Country : South Africa

Acalabrutinib

Brand Name : Calquence 100 mg

Dosage Form : CAP

Dosage Strength : 100mg

Packaging : 56X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Product Web Link

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Corporate PDF

17

AstraZeneca

ASPEN

Not Confirmed

AstraZeneca

ASPEN

Not Confirmed

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Regulatory Info :

Registration Country : Australia

Acalabrutinib

Brand Name : CALQUENCE

Dosage Form :

Dosage Strength :

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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18

Genex Pharma

ASPEN

Not Confirmed

Genex Pharma

ASPEN

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Regulatory Info :

Registration Country : India

ACALABRUTINIB CAPSULES

Brand Name : CAPBRUSAM

Dosage Form : Capsule

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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19

Intas Pharmaceuticals

ASPEN

Not Confirmed

Intas Pharmaceuticals

ASPEN

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Regulatory Info :

Registration Country : India

Acalabrutinib

Brand Name :

Dosage Form : Hard Capsule

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

20

MSN Laboratories

ASPEN

Not Confirmed

MSN Laboratories

ASPEN

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Regulatory Info :

Registration Country : USA

ACALABRUTINIB

Brand Name : ACALABRUTINIB

Dosage Form : CAPSULE

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number : 216833

Regulatory Info :

Registration Country : USA

Portfolio PDF

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