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    Company profile for Organon

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    EVENTS

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

    INSPECTIONS & REGISTRATIONS

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    About

    Organon is a global healthcare company formed through a spinoff from Merck (known as MSD outside of the U.S. and Canada) with a mission to deliver impactful medicines and solutions for a healthier every day. We build upon our strong foundation of more than 60 medicines and other products across a range of areas including reproductive health, heart disease, dermatology, allergies and asthma. We bring these important therapies a...
    Organon is a global healthcare company formed through a spinoff from Merck (known as MSD outside of the U.S. and Canada) with a mission to deliver impactful medicines and solutions for a healthier every day. We build upon our strong foundation of more than 60 medicines and other products across a range of areas including reproductive health, heart disease, dermatology, allergies and asthma. We bring these important therapies around the world, with an international footprint that serves people in more than 140 markets. We believe the diversity of our business provides a sustainable engine of growth so we can continue to invest in and advance

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    CONTACT DETAILS

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    OrganonUnited_States_of_America Flag
    Country
    Country
    U.S.A
    Address
    Address
    30 Hudson Street, Jersey City, NJ 07302
    Telephone
    Telephone
    551-430-6000
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.organon.com/
    Linkedin
    Linkedin
    https://www.linkedin.com/company/organon/
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    YouTube
    Twitter
    Twitter

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    Events

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    NEWS #PharmaBuzz

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    Sun Pharma Looks To Rise In US With $10 Billion Organon Buy
    Sun Pharma Looks To Rise In US With $10 Billion Organon Buy

    18 Jan 2026

    // ECONOMICTIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/sun-pharma-looks-to-rise-inus-with-10-billion-organon-buy/articleshow/126660959.cms

    ECONOMICTIMES
    18 Jan 2026
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    Organon Announces FDA Approval of sNDA Extending Use of Nexplanon
    Organon Announces FDA Approval of sNDA Extending Use of Nexplanon

    17 Jan 2026

    // PHARMIWEB

    https://www.pharmiweb.com/press-release/2026-01-17/organon-announces-us-food-and-drug-administration-approval-of-supplemental-new-drug-application-exte

    PHARMIWEB
    17 Jan 2026
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    Organon To Present At Piper Sandler Healthcare Conference
    Organon To Present At Piper Sandler Healthcare Conference

    25 Nov 2025

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20251125341955/en/Organon-To-Present-at-the-Piper-Sandler-37th-Annual-Healthcare-Conference

    BUSINESSWIRE
    25 Nov 2025
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    FDA Approves POHERDY® as First PERJETA Biosimilar
    FDA Approves POHERDY® as First PERJETA Biosimilar

    17 Nov 2025

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20251117955804/en/Henlius-and-Organon-Announce-US-FDA-Approval-of-POHERDY-pertuzumab-dpzb-the-First-PERJETA-pertuzumab-Biosimilar-in-the-US

    BUSINESSWIRE
    17 Nov 2025
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    Poherdy, First Biosimilar To Roche's Perjeta, Scores FDA Nod
    Poherdy, First Biosimilar To Roche's Perjeta, Scores FDA Nod

    14 Nov 2025

    // FIERCE PHARMA

    https://www.fiercepharma.com/pharma/organon-and-henlius-poherdy-first-biosimilar-roches-perjeta-approved-fda

    FIERCE PHARMA
    14 Nov 2025
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    Organon Releases Q3 2025 Results
    Organon Releases Q3 2025 Results

    10 Nov 2025

    // BUSINESS WIRE

    https://www.businesswire.com/news/home/20251110058374/en/Organon-Reports-Results-for-the-Third-Quarter-Ended-September-30-2025

    BUSINESS WIRE
    10 Nov 2025
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    USDMF

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    01

    Androsterone

    U.S.A
    IPPE
    Not Confirmed
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    02

    Orgabolin Tablets 2 Mg.

    U.S.A
    IPPE
    Not Confirmed
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    03

    Progesterone

    U.S.A
    IPPE
    Not Confirmed
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    FDF Dossiers

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    01

    Brand Name : FOSAMAX

    U.S.A
    IPPE
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    Brand Name : FOSAMAX

    U.S.A
    arrow
    IPPE
    Not Confirmed
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    Regulatory Info : DISCN

    Registration Country : USA

    ALENDRONATE SODIUM

    Organon

    Dosage Form : TABLET;ORAL

    Brand Name : FOSAMAX

    Dosage Strength : EQ 10MG BASE **Federal...

    Packaging :

    Approval Date : 1995-09-29

    Application Number : 20560

    Regulatory Info : DISCN

    Registration Country : USA

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    02

    Brand Name : FOSAMAX

    U.S.A
    Cosmoprof
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    Brand Name : FOSAMAX

    U.S.A
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    Cosmoprof
    Not Confirmed
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    Regulatory Info : DISCN

    Registration Country : USA

    ALENDRONATE SODIUM

    Organon

    Dosage Form : TABLET;ORAL

    Brand Name : FOSAMAX

    Dosage Strength : EQ 40MG BASE **Federal...

    Packaging :

    Approval Date : 1995-09-29

    Application Number : 20560

    Regulatory Info : DISCN

    Registration Country : USA

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    03

    Brand Name : FOSAMAX

    U.S.A
    IPPE
    Not Confirmed
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    Brand Name : FOSAMAX

    U.S.A
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    IPPE
    Not Confirmed
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    Regulatory Info : DISCN

    Registration Country : USA

    ALENDRONATE SODIUM

    Organon

    Dosage Form : TABLET;ORAL

    Brand Name : FOSAMAX

    Dosage Strength : EQ 5MG BASE **Federal ...

    Packaging :

    Approval Date : 1997-04-25

    Application Number : 20560

    Regulatory Info : DISCN

    Registration Country : USA

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    04

    Brand Name : FOSAMAX

    U.S.A
    Cosmoprof
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    Brand Name : FOSAMAX

    U.S.A
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    Cosmoprof
    Not Confirmed
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    Regulatory Info : DISCN

    Registration Country : USA

    ALENDRONATE SODIUM

    Organon

    Dosage Form : TABLET;ORAL

    Brand Name : FOSAMAX

    Dosage Strength : EQ 35MG BASE **Federal...

    Packaging :

    Approval Date : 2000-10-20

    Application Number : 20560

    Regulatory Info : DISCN

    Registration Country : USA

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    05

    Brand Name : FOSAMAX

    U.S.A
    IPPE
    Not Confirmed
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    Brand Name : FOSAMAX

    U.S.A
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    IPPE
    Not Confirmed
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    • EDQM
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    Regulatory Info : RX

    Registration Country : USA

    ALENDRONATE SODIUM

    Organon

    Dosage Form : TABLET;ORAL

    Brand Name : FOSAMAX

    Dosage Strength : EQ 70MG BASE

    Packaging :

    Approval Date : 2000-10-20

    Application Number : 20560

    Regulatory Info : RX

    Registration Country : USA

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    06

    Brand Name : Fosavance 5 600

    U.S.A
    Cosmoprof
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    Brand Name : Fosavance 5 600

    U.S.A
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    Cosmoprof
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    Regulatory Info : Originator

    Registration Country : South Africa

    Alendronate Sodium

    Organon

    Dosage Form : TAB

    Brand Name : Fosavance 5 600

    Dosage Strength : 70mg

    Packaging : 4X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    07

    Brand Name : Fosamax Semenal

    U.S.A
    IPPE
    Not Confirmed
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    Brand Name : Fosamax Semenal

    U.S.A
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    IPPE
    Not Confirmed
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    Regulatory Info : Authorized

    Registration Country : Spain

    Alendronate Sodium Trihydrate

    Organon

    Dosage Form : Tablet

    Brand Name : Fosamax Semenal

    Dosage Strength : 70MG

    Packaging :

    Approval Date : 01-06-2001

    Application Number : 63955

    Regulatory Info : Authorized

    Registration Country : Spain

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    08

    Brand Name : FOSAMAX PLUS D

    U.S.A
    IPPE
    Not Confirmed
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    Brand Name : FOSAMAX PLUS D

    U.S.A
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    IPPE
    Not Confirmed
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    Regulatory Info : RX

    Registration Country : USA

    ALENDRONATE SODIUM; CHOLECALCIFEROL

    Organon

    Dosage Form : TABLET;ORAL

    Brand Name : FOSAMAX PLUS D

    Dosage Strength : EQ 70MG BASE;2,800 IU

    Packaging :

    Approval Date : 2005-04-07

    Application Number : 21762

    Regulatory Info : RX

    Registration Country : USA

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    09

    Brand Name : FOSAMAX PLUS D

    U.S.A
    Cosmoprof
    Not Confirmed
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    Brand Name : FOSAMAX PLUS D

    U.S.A
    arrow
    Cosmoprof
    Not Confirmed
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    • EDQM
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    Regulatory Info : RX

    Registration Country : USA

    ALENDRONATE SODIUM; CHOLECALCIFEROL

    Organon

    Dosage Form : TABLET;ORAL

    Brand Name : FOSAMAX PLUS D

    Dosage Strength : EQ 70MG BASE;5,600 IU

    Packaging :

    Approval Date : 2007-04-26

    Application Number : 21762

    Regulatory Info : RX

    Registration Country : USA

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    10

    Brand Name : FOSAMAX

    U.S.A
    Cosmoprof
    Not Confirmed
    arrow

    Brand Name : FOSAMAX

    U.S.A
    arrow
    Cosmoprof
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info :

    Registration Country : Italy

    Alendronic acid

    Organon

    Dosage Form : Tablets

    Brand Name : FOSAMAX

    Dosage Strength : 70 mg

    Packaging : 4 UNITS 70 MG - ORAL USE

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    FDA Orange Book

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    Inspections and registrations

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    ABOUT THIS PAGE

    Contact Organon and get a quotation

    Organon is a supplier offers 3 products (APIs, Excipients or Intermediates).

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