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

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Acalabrutinib
FDA Orange Book

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

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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

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Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.

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Acalabrutinib

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

20 API Suppliers, 8 USDMF, 2 EU WC, 2 KDMF, 6 NDC API, 11 Listed Suppliers, $ API Reference Price

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

DEVELOPMENTS

31 Drugs in Development

31 Drugs in Development

INTERMEDIATES

20 Intermediate Suppliers

20 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, 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
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
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

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

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

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) : 22,511 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

02 2Blank

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01 2ACALABRUTINIB

02 2CALQUENCE

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01 2Yes

02 2Blank

List of Suppliers

Product Main Page

01

ALEMBIC PHARMS LTD

BIO Asia-Taiwan

Not Confirmed

ALEMBIC PHARMS LTD

BIO Asia-Taiwan

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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

BIO Asia-Taiwan

Not Confirmed

ASTRAZENECA

BIO Asia-Taiwan

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

BIO Asia-Taiwan

Not Confirmed

ASTRAZENECA

BIO Asia-Taiwan

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

BIO Asia-Taiwan

Not Confirmed

MSN LABORATORIES PRIVATE LTD

BIO Asia-Taiwan

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

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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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