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    EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Munit offers scalable GMP micronization and particle size engineering to enhance drug solubility, bioavailability, and performance.

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    Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.

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    Inke S.A: APIs manufacturing plant.

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    Alchem offers Botanical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.

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    Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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    Berotralstat

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    01 4BioCryst Pharmaceuticals

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    01

    BioCryst Pharmaceuticals

    U.S.A
    Aus. Peptide Conference
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    BioCryst Pharmaceuticals

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    Regulatory Info : RX

    Registration Country : USA

    BEROTRALSTAT HYDROCHLORIDE

    Brand Name : ORLADEYO

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : EQ 110MG BASE

    Packaging :

    Approval Date : 2020-12-03

    Application Number : 214094

    Regulatory Info : RX

    Registration Country : USA

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    02

    BioCryst Pharmaceuticals

    U.S.A
    Aus. Peptide Conference
    Not Confirmed
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    BioCryst Pharmaceuticals

    U.S.A
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    Aus. Peptide Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : RX

    Registration Country : USA

    BEROTRALSTAT HYDROCHLORIDE

    Brand Name : ORLADEYO

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : EQ 150MG BASE

    Packaging :

    Approval Date : 2020-12-03

    Application Number : 214094

    Regulatory Info : RX

    Registration Country : USA

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    03

    BioCryst Pharmaceuticals

    U.S.A
    Aus. Peptide Conference
    Not Confirmed
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    BioCryst Pharmaceuticals

    U.S.A
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    Aus. Peptide Conference
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    • fda
    • EDQM
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Berotralstatum

    Brand Name : Orladeyo

    Dosage Form : Hard Capsule

    Dosage Strength : 150mg

    Packaging :

    Approval Date : 07/06/2022

    Application Number : 68464

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    04

    BioCryst Pharmaceuticals

    U.S.A
    Aus. Peptide Conference
    Not Confirmed
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    BioCryst Pharmaceuticals

    U.S.A
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    Aus. Peptide Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : Authorized

    Registration Country : Spain

    Berotralstat Dihydrochloride

    Brand Name : Orladeyo

    Dosage Form : Hard Capsule

    Dosage Strength : 150MG

    Packaging :

    Approval Date : 2022-11-30

    Application Number : 1211544001

    Regulatory Info : Authorized

    Registration Country : Spain

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    05

    Biocryst Ireland Limited

    Country
    Aus. Peptide Conference
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    Biocryst Ireland Limited

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    Aus. Peptide Conference
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    • fda
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    Regulatory Info : Approved

    Registration Country : Sweden

    Berotralstatdihydroklorid

    Brand Name : Orladeyo

    Dosage Form : Capsule

    Dosage Strength : 150mg

    Packaging :

    Approval Date : 30/04/2021

    Application Number : 20200311000025

    Regulatory Info : Approved

    Registration Country : Sweden

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