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01 1Alembic Pharmaceuticals Limited

02 1Aprazer

03 22AstraZeneca

04 1Genex Pharma

05 1Intas Pharmaceuticals

06 1MSN Laboratories

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PharmaCompass

01

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

ACALABRUTINIB

Brand Name : ACALABRUTINIB

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number : 216775

Regulatory Info :

Registration Country : USA

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02

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Acalabrutinib

Brand Name : ACALAKAST

Dosage Form : Capsule

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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03

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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

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04

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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

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05

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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

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06

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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

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07

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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

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08

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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

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09

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Acalabrutinib

Brand Name : Calquence

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 01-07-2024

Application Number :

Regulatory Info :

Registration Country : Moldova

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10

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Akalabrutinib

Brand Name : Calquence

Dosage Form : Capsule

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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11

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Akalabrutinib

Brand Name : Calquence

Dosage Form : Film Coated Tablet

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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12

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Acalabrutinib

Brand Name : Calquence

Dosage Form : Capsule

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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13

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Acalabrutinib

Brand Name : Calquence

Dosage Form : Film-Coated Tablet

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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14

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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

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15

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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

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16

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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

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17

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

ACALABRUTINIB (ACALABRUTINIB MALEATE)

Brand Name : CALQUENCE

Dosage Form : TABLET

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number : 2535696

Regulatory Info : Prescription

Registration Country : Canada

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18

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Acalabrutinib

Brand Name :

Dosage Form : Hard Capsule

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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20

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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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