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Synopsis

ACTIVE PHARMA INGREDIENTS

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USDMF

US DMFs Filed

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CEP/COS

CEP/COS Certifications

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JDMF

JDMFs Filed

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EU WC

EU WC

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KDMF

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NDC API

NDC API

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VMF

NDC API

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REF. STANDARDS OR IMPURITIES

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USP

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Others

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MARKET PLACE

Chemistry

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Europe

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01

COMPAMED
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COMPAMED
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Omalizumab

Brand Name : Omlyclo

Dosage Form : Solution For Injection

Dosage Strength : 75mg

Packaging :

Approval Date : 16/05/2024

Application Number : 20230425000031

Regulatory Info : Approved

Registration Country : Sweden

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02

COMPAMED
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COMPAMED
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Omalizumab

Brand Name : Xolair

Dosage Form : Solution for injection

Dosage Strength : 75 mg

Packaging : Pre-filled syringe 0.5ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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03

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Omalizumab

Brand Name : Xolair

Dosage Form : Solution for injection

Dosage Strength : 75 mg

Packaging : Pre-filled syringe 0.5ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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04

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Omalizumab

Brand Name : Xolair

Dosage Form : Solution For Injection

Dosage Strength : 150mg

Packaging :

Approval Date : 25/10/2005

Application Number : 20040916000507

Regulatory Info : Approved

Registration Country : Sweden

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05

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Omalizumab

Brand Name : Xolair

Dosage Form : Solution For Injection

Dosage Strength : 300mg

Packaging :

Approval Date : 06/11/2023

Application Number : 20220729000127

Regulatory Info : Approved

Registration Country : Sweden

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06

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Omalizumab

Brand Name : Xolair

Dosage Form : Solution For Injection

Dosage Strength : 75mg

Packaging :

Approval Date : 25/10/2005

Application Number : 20040916000491

Regulatory Info : Approved

Registration Country : Sweden

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07

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Omalizumabum

Brand Name : Xolair

Dosage Form : Solution For Injection

Dosage Strength : 150mg

Packaging :

Approval Date : 18/09/2006

Application Number : 57178

Regulatory Info : Allowed

Registration Country : Switzerland

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08

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Omalizumabum

Brand Name : Xolair

Dosage Form : Solution For Injection

Dosage Strength : 150mg/ml

Packaging :

Approval Date : 03/07/2024

Application Number : 69272

Regulatory Info : Allowed

Registration Country : Switzerland

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09

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Omalizumab

Brand Name : Xolair

Dosage Form : Injectable Solution

Dosage Strength : 150MG

Packaging :

Approval Date : 2009-03-12

Application Number : 05319008

Regulatory Info : Authorized

Registration Country : Spain

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10

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Omalizumab

Brand Name : Xolair

Dosage Form : Powder And Solvent For Injectable Solution

Dosage Strength : 150MG

Packaging :

Approval Date : 2005-11-10

Application Number : 05319002

Regulatory Info : Authorized

Registration Country : Spain

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