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    Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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    Fosnetupitant Chloride

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    01

    Helsinn Advanced Synthesis

    Switzerland
    Fall Technical Meeting
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    Helsinn Advanced Synthesis

    Switzerland
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    Fall Technical Meeting
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    Regulatory Info : DISCN

    Registration Country : USA

    FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

    Brand Name : AKYNZEO

    Dosage Form : POWDER;INTRAVENOUS

    Dosage Strength : EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL

    Packaging :

    Approval Date : 2018-04-19

    Application Number : 210493

    Regulatory Info : DISCN

    Registration Country : USA

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    02

    Helsinn Advanced Synthesis

    Switzerland
    Fall Technical Meeting
    Not Confirmed
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    Helsinn Advanced Synthesis

    Switzerland
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    Fall Technical Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : RX

    Registration Country : USA

    FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

    Brand Name : AKYNZEO

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)

    Packaging :

    Approval Date : 2020-05-27

    Application Number : 210493

    Regulatory Info : RX

    Registration Country : USA

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    03

    Helsinn Advanced Synthesis

    Switzerland
    Fall Technical Meeting
    Not Confirmed
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    Helsinn Advanced Synthesis

    Switzerland
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    Fall Technical Meeting
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    Regulatory Info : Approved

    Registration Country : Sweden

    Fosnetupitant Chloride Hydrochloride; Palonosetron Hydrochloride

    Brand Name : Akynzeo

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 235mg/0.25mg

    Packaging :

    Approval Date : 12/11/2021

    Application Number : 20200916000079

    Regulatory Info : Approved

    Registration Country : Sweden

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    04

    Helsinn Advanced Synthesis

    Switzerland
    Fall Technical Meeting
    Not Confirmed
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    Helsinn Advanced Synthesis

    Switzerland
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    Fall Technical Meeting
    Not Confirmed
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    Regulatory Info : Approved

    Registration Country : Sweden

    Fosnetupitant Chloride Hydrochloride; Palonosetron Hydrochloride

    Brand Name : Akynzeo

    Dosage Form : Powder For Concentrate For Solution For Infusion

    Dosage Strength : 235mg/0.25mg

    Packaging :

    Approval Date : 16/03/2020

    Application Number : 20181108000049

    Regulatory Info : Approved

    Registration Country : Sweden

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    05

    Helsinn Advanced Synthesis

    Switzerland
    Fall Technical Meeting
    Not Confirmed
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    Helsinn Advanced Synthesis

    Switzerland
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    Fall Technical Meeting
    Not Confirmed
    • fda
    • EDQM
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    Regulatory Info : Authorized

    Registration Country : Spain

    Palonosetron Hydrochloride; Fosnetupitant

    Brand Name : Akynzeo

    Dosage Form : Powder For Concentrate For Solution For Infusion

    Dosage Strength : 235MG; 0.25 MG

    Packaging :

    Approval Date : 2020-06-10

    Application Number : 1151001003

    Regulatory Info : Authorized

    Registration Country : Spain

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    06

    Medius Ag

    Country
    Fall Technical Meeting
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    Medius Ag

    Country
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    Fall Technical Meeting
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Fosnetupitant; Palonosetron

    Brand Name : Akynzeo IV

    Dosage Form : Concentrate For Solution For Infusion

    Dosage Strength : 235mg;0.25mg

    Packaging :

    Approval Date : 01/09/2022

    Application Number : 68290

    Regulatory Info : Allowed

    Registration Country : Switzerland

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