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

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Acalabrutinib
FDA Orange Book

With Fermion, start the journey of your innovative API.

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Suanfarma CDMO offers integrated end-to-end solutions for development & commercialization of intermediates & APIs for small molecules.

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

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Acalabrutinib

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

19 API Suppliers, 8 USDMF, 2 EU WC, 2 KDMF, 6 NDC API, 10 Listed Suppliers, $ API Reference Price

19 API Suppliers
8 USDMF
2 EU WC
2 KDMF
6 NDC API
10 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

31 Drugs in Development

31 Drugs in Development

INTERMEDIATES

16 Intermediate Suppliers

16 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

13 FDF Dossiers, 4 FDA Orange Book, 2 Europe, 1 Canada, 4 Australia, 1 South Africa, 1 Listed Dossiers

13 FDF Dossiers
4 FDA Orange Book
2 Europe
1 Canada
4 Australia
1 South Africa
1 Listed Dossiers

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 7 DKSH, 2 Faran Shimi Pharmaceutical, 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, 4 Kerry, 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
2 Faran Shimi Pharmaceutical
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
4 Kerry
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

35 Fillers, Diluents & Binders, 16 Disintegrants & Superdisintegrants, 15 Thickeners and Stabilizers, 13 Co-Processed Excipients, 12 Direct Compression, 11 Lubricants & Glidants, 8 Empty Capsules, 8 Coating Systems & Additives, 7 Granulation, 6 Taste Masking, 5 Chewable & Orodispersible Aids, 4 Controlled & Modified Release, 3 Emulsifying Agents, 3 Film Formers & Plasticizers, 2 Coloring Agents, 1 Rheology Modifiers, 1 API Stability Enhancers

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

DIGITAL CONTENT

73 News #PharmaBuzz

73 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 2 Regulatory FDF Prices, 8 Annual Reports

2 US Medicaid Prescriptions
2 Regulatory FDF Prices
8 Annual Reports

MARKET PLACE

1 APIs, 1 FDF Dossiers

1 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

61 US Patents, 3 US Exclusivities

61 US Patents
3 US Exclusivities

$ API Ref.Price (USD/KG) : 24,256 Xls

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01 1ALEMBIC PHARMS LTD

02 2ASTRAZENECA

03 1MSN LABORATORIES PRIVATE LTD

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01 1CAPSULE

02 2CAPSULE;ORAL

03 1TABLET;ORAL

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01 2RX

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01 2ACALABRUTINIB

02 2CALQUENCE

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01 2Yes

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List of Suppliers

Product Main Page

01

ALEMBIC PHARMS LTD

Indo Livestock Expo

Not Confirmed

ALEMBIC PHARMS LTD

Indo Livestock Expo

Not Confirmed

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Digital Content

RLD :

TE Code :

ACALABRUTINIB

Brand Name : ACALABRUTINIB

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date :

Application Number : 216775

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

ASTRAZENECA

Indo Livestock Expo

Not Confirmed

ASTRAZENECA

Indo Livestock Expo

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

ACALABRUTINIB

Brand Name : CALQUENCE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 2017-10-31

Application Number : 210259

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

ASTRAZENECA

Indo Livestock Expo

Not Confirmed

ASTRAZENECA

Indo Livestock Expo

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

ACALABRUTINIB MALEATE

Brand Name : CALQUENCE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 100MG BASE

Approval Date : 2022-08-03

Application Number : 216387

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

MSN LABORATORIES PRIVATE LTD

Indo Livestock Expo

Not Confirmed

MSN LABORATORIES PRIVATE LTD

Indo Livestock Expo

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 :

TE Code :

ACALABRUTINIB

Brand Name : ACALABRUTINIB

Dosage Form : CAPSULE

Dosage Strength : 100MG

Approval Date :

Application Number : 216833

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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