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    Aspen API. More than just an API™

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    Sharp is a leader in commercial packaging, clinical services, and sterile manufacturing.

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    pharmacompass-1-m-2026-01-12

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    Suanfarma, at the Core of a Better Life.

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    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    Berotralstat Hydrochloride

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    01 1BioCryst Ireland Limited

    02 9BioCryst Pharmaceuticals

    03 3Biocryst Ireland Limited

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    01

    BioCryst Pharmaceuticals

    U.S.A
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    BioCryst Pharmaceuticals

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    Regulatory Info : RX

    Registration Country : USA

    BEROTRALSTAT DIHYDROCHLORIDE

    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
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    BioCryst Pharmaceuticals

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    Regulatory Info : RX

    Registration Country : USA

    BEROTRALSTAT DIHYDROCHLORIDE

    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

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    BioCryst Pharmaceuticals

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    Regulatory Info : RX

    Registration Country : USA

    BEROTRALSTAT DIHYDROCHLORIDE

    Brand Name : ORLADEYO

    Dosage Form : PELLETS;ORAL

    Dosage Strength : EQ 72MG BASE/PACKET

    Packaging :

    Approval Date : 2025-12-11

    Application Number : 219776

    Regulatory Info : RX

    Registration Country : USA

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    04

    BioCryst Pharmaceuticals

    U.S.A
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    BioCryst Pharmaceuticals

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    Regulatory Info : RX

    Registration Country : USA

    BEROTRALSTAT DIHYDROCHLORIDE

    Brand Name : ORLADEYO

    Dosage Form : PELLETS;ORAL

    Dosage Strength : EQ 96MG BASE/PACKET

    Packaging :

    Approval Date : 2025-12-11

    Application Number : 219776

    Regulatory Info : RX

    Registration Country : USA

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    05

    BioCryst Pharmaceuticals

    U.S.A
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    BioCryst Pharmaceuticals

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    BEROTRALSTAT DIHYDROCHLORIDE

    Brand Name : ORLADEYO

    Dosage Form : PELLETS;ORAL

    Dosage Strength : EQ 108MG BASE/PACKET

    Packaging :

    Approval Date : 2025-12-11

    Application Number : 219776

    Regulatory Info : RX

    Registration Country : USA

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    06

    BioCryst Pharmaceuticals

    U.S.A
    ASPEN
    Not Confirmed
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    BioCryst Pharmaceuticals

    U.S.A
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    ASPEN
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    Regulatory Info : RX

    Registration Country : USA

    BEROTRALSTAT DIHYDROCHLORIDE

    Brand Name : ORLADEYO

    Dosage Form : PELLETS;ORAL

    Dosage Strength : EQ 132MG BASE/PACKET

    Packaging :

    Approval Date : 2025-12-11

    Application Number : 219776

    Regulatory Info : RX

    Registration Country : USA

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    07

    BioCryst Pharmaceuticals

    U.S.A
    ASPEN
    Not Confirmed
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    BioCryst Pharmaceuticals

    U.S.A
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    ASPEN
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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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    08

    BioCryst Pharmaceuticals

    U.S.A
    ASPEN
    Not Confirmed
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    BioCryst Pharmaceuticals

    U.S.A
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    ASPEN
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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 : 30-11-2022

    Application Number : 1211544001

    Regulatory Info : Authorized

    Registration Country : Spain

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    09

    BioCryst Pharmaceuticals

    U.S.A
    ASPEN
    Not Confirmed
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    BioCryst Pharmaceuticals

    U.S.A
    arrow
    ASPEN
    Not Confirmed
    • fda
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    Regulatory Info : Prescription

    Registration Country : Canada

    BEROTRALSTAT (BEROTRALSTAT HYDROCHLORIDE)

    Brand Name : ORLADEYO

    Dosage Form : CAPSULE

    Dosage Strength : 150MG

    Packaging :

    Approval Date :

    Application Number : 2527693

    Regulatory Info : Prescription

    Registration Country : Canada

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    10

    Biocryst Ireland Limited

    Country
    ASPEN
    Not Confirmed
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    Biocryst Ireland Limited

    Country
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    ASPEN
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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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    11

    BioCryst Ireland Limited

    Country
    ASPEN
    Not Confirmed
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    BioCryst Ireland Limited

    Country
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    ASPEN
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    Regulatory Info : Marketed

    Registration Country : Norway

    Berotralstat hydrochloride

    Brand Name : Orladeyo

    Dosage Form : Capsule

    Dosage Strength : 150mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Marketed

    Registration Country : Norway

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    12

    Biocryst Ireland Limited

    Country
    ASPEN
    Not Confirmed
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    Biocryst Ireland Limited

    Country
    arrow
    ASPEN
    Not Confirmed
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    Regulatory Info : Prescription

    Registration Country : Estonia

    Berotralstat

    Brand Name : Orladeyo

    Dosage Form : Capsule

    Dosage Strength : 150mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Prescription

    Registration Country : Estonia

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    13

    Biocryst Ireland Limited

    Country
    ASPEN
    Not Confirmed
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    Biocryst Ireland Limited

    Country
    arrow
    ASPEN
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    Regulatory Info : Prescription

    Registration Country : Denmark

    Berotralstat Hydrochloride

    Brand Name : Orladeyo

    Dosage Form : Hard Capsules

    Dosage Strength : 150mg

    Packaging :

    Approval Date : 30-04-2021

    Application Number : 28106421020

    Regulatory Info : Prescription

    Registration Country : Denmark

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    • Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.