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    Cloperastine Fendizoate

    ACTIVE PHARMA INGREDIENTS

    INTERMEDIATES

    FINISHED DOSAGE FORMULATIONS

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    01 2Almirall

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    03 2Kern Pharma S.L.

    04 1LABORATORIOS NORMON SA

    05 1Nutra Essential Otc Sl

    06 1Valeas

    07 2Zambon Group SpA

    08 3Zambon Switzerland

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    01

    Almirall

    Spain
    IPPE
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    Almirall

    Spain
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    Regulatory Info :

    Registration Country :

    Cloperastine Fendizoate

    Brand Name : SEKISAN

    Dosage Form : Syrup

    Dosage Strength : 3.54MG/1ML

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    Approval Date :

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    Registration Country :

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    02

    Almirall

    Spain
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    Almirall

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    Regulatory Info : Authorized

    Registration Country : Spain

    Cloperastina Fendizoate

    Brand Name : Sekisan

    Dosage Form : Syrup

    Dosage Strength : 3.54MG

    Packaging :

    Approval Date : 29-05-1984

    Application Number : 56281

    Regulatory Info : Authorized

    Registration Country : Spain

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    03

    Cinfa

    Spain
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    Cinfa

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    Cloperastine Fendizoate

    Brand Name : Cinfatusina

    Dosage Form : Oral Suspension

    Dosage Strength : 3.54MG/1ML

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    04

    Cinfa

    Spain
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    Cinfa

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    Regulatory Info : Authorized

    Registration Country : Spain

    Cloperastina Fendizoate

    Brand Name : Cinfatusina

    Dosage Form : Oral Suspension

    Dosage Strength : 3.54MG

    Packaging :

    Approval Date : 02-09-2010

    Application Number : 72690

    Regulatory Info : Authorized

    Registration Country : Spain

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    05

    Kern Pharma S.L.

    Spain
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    Kern Pharma S.L.

    Spain
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    Regulatory Info : Authorized

    Registration Country : Spain

    Cloperastina Fendizoate

    Brand Name : Cloperastina Kern Pharma

    Dosage Form : Syrup

    Dosage Strength : 3.54MG

    Packaging :

    Approval Date : 01-08-2011

    Application Number : 74511

    Regulatory Info : Authorized

    Registration Country : Spain

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    06

    Kern Pharma S.L.

    Spain
    IPPE
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    Kern Pharma S.L.

    Spain
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    Regulatory Info : Authorized

    Registration Country : Spain

    Cloperastina Fendizoate

    Brand Name : Tussal

    Dosage Form : Syrup

    Dosage Strength : 35.4MG

    Packaging :

    Approval Date : 25-04-2024

    Application Number : 89519

    Regulatory Info : Authorized

    Registration Country : Spain

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    07

    LABORATORIOS NORMON SA

    Spain
    IPPE
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    LABORATORIOS NORMON SA

    Spain
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    IPPE
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    Regulatory Info : Authorized

    Registration Country : Spain

    Cloperastina Fendizoate

    Brand Name : Cloperastina Normon

    Dosage Form : Oral Suspension

    Dosage Strength : 3.54MG

    Packaging :

    Approval Date : 15-11-2010

    Application Number : 73003

    Regulatory Info : Authorized

    Registration Country : Spain

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    08

    Valeas

    Italy
    IPPE
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    Valeas

    Italy
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    Regulatory Info :

    Registration Country :

    Cloperastine Fendizoate

    Brand Name : Quik

    Dosage Form : Oral Suspension

    Dosage Strength : 200ML

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country :

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    09

    Zambon Group SpA

    Italy
    IPPE
    Not Confirmed
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    Zambon Group SpA

    Italy
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    IPPE
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    Regulatory Info :

    Registration Country :

    Cloperastine Fendizoate

    Brand Name : Flutox

    Dosage Form : Syrup

    Dosage Strength : 3.4MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country :

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    10

    Zambon Group SpA

    Italy
    IPPE
    Not Confirmed
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    Zambon Group SpA

    Italy
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    IPPE
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    Regulatory Info : Authorized

    Registration Country : Spain

    Cloperastina Fendizoate

    Brand Name : Flutox

    Dosage Form : Syrup

    Dosage Strength : 3.54MG

    Packaging :

    Approval Date : 01-12-1988

    Application Number : 57849

    Regulatory Info : Authorized

    Registration Country : Spain

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    11

    Zambon Switzerland

    Switzerland
    IPPE
    Not Confirmed
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    Zambon Switzerland

    Switzerland
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    IPPE
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    Regulatory Info :

    Registration Country :

    Cloperastine Fendizoate

    Brand Name : Seki

    Dosage Form : Syrup

    Dosage Strength : 3.54MG/1ML

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country :

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    12

    Zambon Switzerland

    Switzerland
    IPPE
    Not Confirmed
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    Zambon Switzerland

    Switzerland
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    IPPE
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    Regulatory Info : Authorized

    Registration Country : Spain

    Cloperastina Fendizoate

    Brand Name : Flutox

    Dosage Form : Lozenge

    Dosage Strength : 17.7MG

    Packaging :

    Approval Date : 29-09-2025

    Application Number : 90592

    Regulatory Info : Authorized

    Registration Country : Spain

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    13

    Zambon Switzerland

    Switzerland
    IPPE
    Not Confirmed
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    Zambon Switzerland

    Switzerland
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    IPPE
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    Regulatory Info : Authorized

    Registration Country : Spain

    Cloperastina Fendizoate

    Brand Name : Flutox

    Dosage Form : Lozenge

    Dosage Strength : 35.4MG

    Packaging :

    Approval Date : 29-09-2025

    Application Number : 90594

    Regulatory Info : Authorized

    Registration Country : Spain

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    14

    Nutra Essential Otc Sl

    Country
    IPPE
    Not Confirmed
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    Nutra Essential Otc Sl

    Country
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    IPPE
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    Regulatory Info : Authorized

    Registration Country : Spain

    Cloperastina Fendizoate

    Brand Name : Cloperastina Nutra Essential

    Dosage Form : Syrup

    Dosage Strength : 3.54MG

    Packaging :

    Approval Date : 29-09-2025

    Application Number : 90593

    Regulatory Info : Authorized

    Registration Country : Spain

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