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Acalabrutinib
FDF Dossiers

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

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IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

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medac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.

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Coral

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ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.

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Acalabrutinib

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

20 API Suppliers, 8 USDMF, 2 EU WC, 2 KDMF, 7 NDC API, 11 Listed Suppliers, $ API Reference Price

20 API Suppliers
8 USDMF
2 EU WC
2 KDMF
7 NDC API
11 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

144 Drugs in Development

144 Drugs in Development

INTERMEDIATES

20 Intermediate Suppliers

20 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

16 FDF Dossiers, 4 FDA Orange Book, 6 Europe, 4 Australia, 1 South Africa, 1 Listed Dossiers

16 FDF Dossiers
4 FDA Orange Book
6 Europe
4 Australia
1 South Africa
1 Listed Dossiers

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 7 DKSH, 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
7 DKSH
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

34 Fillers, Diluents & Binders, 16 Disintegrants & Superdisintegrants, 15 Thickeners and Stabilizers, 12 Direct Compression, 11 Lubricants & Glidants, 10 Co-Processed Excipients, 8 Empty Capsules, 7 Coating Systems & Additives, 7 Granulation, 6 Chewable & Orodispersible Aids, 6 Taste Masking, 3 Emulsifying Agents, 3 Film Formers & Plasticizers, 3 Controlled & Modified Release, 2 Coloring Agents, 1 API Stability Enhancers, 1 Rheology Modifiers

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

DIGITAL CONTENT

74 News #PharmaBuzz

74 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) : 20,766 Xls

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16 All

01 1Alembic Pharmaceuticals Limited

02 13AstraZeneca

03 1Intas Pharmaceuticals

04 1MSN Laboratories

filter Dosage Reset all filters

16 All

01 1CAP

02 1CAPSULE

03 2CAPSULE;ORAL

04 1Capsule

05 3Film Coated Tablet

06 3Hard Capsule

07 1TABLET;ORAL

08 4Blank

filter Regulatory Info Reset all filters

16 All

01 2Allowed

02 2Approved

03 2Authorized

04 1Originator

05 2RX

06 7Blank

filter Brand Name Reset all filters

16 All

01 2ACALABRUTINIB

02 6CALQUENCE

03 6Calquence

04 1Calquence 100 mg

05 1Blank

filter Country Reset all filters

16 All

01 4Australia

02 1India

03 1South Africa

04 2Spain

05 2Sweden

06 2Switzerland

07 4USA

List of Suppliers

Product Main Page

01

Alembic Pharmaceuticals Limited

Organic Process R&D

Not Confirmed

Alembic Pharmaceuticals Limited

Organic Process R&D

Not Confirmed

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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

AstraZeneca

Organic Process R&D

Not Confirmed

AstraZeneca

Organic Process R&D

Not Confirmed

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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

03

AstraZeneca

Organic Process R&D

Not Confirmed

AstraZeneca

Organic Process R&D

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

04

AstraZeneca

Organic Process R&D

Not Confirmed

AstraZeneca

Organic Process R&D

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Acalabrutinib

Brand Name : Calquence

Dosage Form : Capsule

Dosage Strength : 100mg

Packaging :

Approval Date : 2020-11-05

Application Number : 20191015000025

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

AstraZeneca

Organic Process R&D

Not Confirmed

AstraZeneca

Organic Process R&D

Not Confirmed

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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

Organic Process R&D

Not Confirmed

AstraZeneca

Organic Process R&D

Not Confirmed

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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

Organic Process R&D

Not Confirmed

AstraZeneca

Organic Process R&D

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Acalabrutinib Maleate Monohydrate

Brand Name : Calquence

Dosage Form : Film Coated Tablet

Dosage Strength : 100mg

Packaging :

Approval Date : 2023-02-20

Application Number : 20211012000078

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

AstraZeneca

Organic Process R&D

Not Confirmed

AstraZeneca

Organic Process R&D

Not Confirmed

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Digital Content

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

AstraZeneca

Organic Process R&D

Not Confirmed

AstraZeneca

Organic Process R&D

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Australia

Acalabrutinib

Brand Name : CALQUENCE

Dosage Form :

Dosage Strength :

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

AstraZeneca

Organic Process R&D

Not Confirmed

AstraZeneca

Organic Process R&D

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Australia

Acalabrutinib

Brand Name : CALQUENCE

Dosage Form :

Dosage Strength :

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

11

AstraZeneca

Organic Process R&D

Not Confirmed

AstraZeneca

Organic Process R&D

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Australia

Acalabrutinib

Brand Name : CALQUENCE

Dosage Form :

Dosage Strength :

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

12

AstraZeneca

Organic Process R&D

Not Confirmed

AstraZeneca

Organic Process R&D

Not Confirmed

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Post an Enquiry

Digital Content

Regulatory Info :

Registration Country : Australia

Acalabrutinib

Brand Name : CALQUENCE

Dosage Form :

Dosage Strength :

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

13

AstraZeneca

Organic Process R&D

Not Confirmed

AstraZeneca

Organic Process R&D

Not Confirmed

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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 : 2023-06-21

Application Number : 1201479004

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

14

AstraZeneca

Organic Process R&D

Not Confirmed

AstraZeneca

Organic Process R&D

Not Confirmed

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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 : 2020-11-18

Application Number : 1201479002

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

15

Intas Pharmaceuticals

Organic Process R&D

Not Confirmed

Intas Pharmaceuticals

Organic Process R&D

Not Confirmed

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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

16

MSN Laboratories

Organic Process R&D

Not Confirmed

MSN Laboratories

Organic Process R&D

Not Confirmed

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Digital Content

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

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