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    Company profile for Cosma

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    US FDA Issues Form 483 to Cosma SpA

    11 May 2017

    // FDA

    Pfizer, Allergan merger hits US taxpayers

    26 Nov 2015

    // THE NEWS & OBSERVER

    AbbVie in Talks to Acquire Gilgamesh in $1 Billion Deal

    31 Jul 2025

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    Cosma S.p.A.: FDA-approved API manufacturing with 300+ tons capacity, serving pharma and animal health industries worldwide.

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    About

    Cosma S.p.A., established in 1977 in Bergamo, northern Italy, is the largest manufacturing site within the CFM group, with a 130,000L (130 m³) glass-lined reaction volume and over 300 tons of annual API output. Originally founded to introduce the CFM group into the U.S. generic market, Cosma was FDA-approved in 1984 and continues to export over 50% of its production to the U.S. Today, Cosma supports leading global generic and branded pharmaceutical companies, while also maintaining a strong presence in the animal health sector. Covering more than 5,000 m², Cosma is recognized for its scale, regulatory excellence, and reliability.

    CONTACT DETAILS

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    CosmaItaly Flag
    Country
    Country
    Italy
    Address
    Address
    Via Colleoni 15-17, 24040 Ciserano, Bergamo 167479
    Telephone
    Telephone
    +39 023925326
    Client Email
    Email
    sales@cosma.it
    Client Website
    Website
    https://www.cfm-group.it/cosma/
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    Linkedin
    youtube
    YouTube
    Twitter
    Twitter
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    Events

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    Product List 2025

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    NEWS #PharmaBuzz

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    US FDA Issues Form 483 to Cosma SpA
    US FDA Issues Form 483 to Cosma SpA

    11 May 2017

    // FDA

    https://www.pharmacompass.com/pdf/news/us-fda-issues-form-483-to-cosma-spa-1502342640.pdf

    FDA
    11 May 2017
    Share Share
    Pfizer, Allergan merger hits US taxpayers
    Pfizer, Allergan merger hits US taxpayers

    26 Nov 2015

    // THE NEWS & OBSERVER

    http://www.newsobserver.com/opinion/editorials/article46524045.html?

    THE NEWS & OBSERVER
    26 Nov 2015
    Share Share

    ALL APIs

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    read-moreClick the button for full data set

    01

    Flecainide

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPhI WW Frankfurt
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14749

    Submission : 2000-02-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2009-363 - Rev 03

    Issue Date : 2023-12-06

    Type : Chemical

    Substance Number : 1324

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 223MF10093

    Registrant's Address : VIALE DEL GHISALLO, 20 20151 MILAN ITALY

    Initial Date of Registration : 2011-06-29

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 17373-1283

    Start Marketing Date : 2009-07-30

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF VMF ASMF arrow-down
    ✖
    Available Reg. Filing : ASMF
    AUDIT
    Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    Meloxicam

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPhI WW Frankfurt
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-04-01

    Pay. Date : 2016-03-02

    DMF Number : 17238

    Submission : 2004-03-16

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-430 - Rev 00

    Issue Date : 2024-08-16

    Type : Chemical

    Substance Number : 2373

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF11036

    Registrant's Address : VIALE DEL GHISALLO, 20 20151 MILAN ITALY

    Initial Date of Registration : 2006-12-28

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 17373-1157

    Start Marketing Date : 2017-01-02

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF arrow-down
    ✖

    Registrant Name : IMCD Korea Co., Ltd.

    Registration Date : 2012-11-09

    Registration Number : 20120106-148-I-39-16(1)

    Manufacturer Name : AMSA SpA

    Manufacturer Address : Via G. di Vittorio, 6 22100 COMO

     VMF ASMF arrow-down
    ✖
    Available Reg. Filing : ASMF
    AUDIT
    Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Amisulpride

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Vietnam Medi-Pharm Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCosma S.p.A.: FDA-approved API manufacturing with 300+ tons capacity, serving pharma and animal health industries worldwide.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 33911

    Submission : 2019-06-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2009-397 - Rev 01

    Issue Date : 2017-08-24

    Type : Chemical

    Substance Number : 1490

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 51604-1156

    Start Marketing Date : 2019-05-29

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF VMF ASMF arrow-down
    ✖
    Available Reg. Filing : ASMF
    AUDIT
    Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    Glycopyrronium Bromide

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPhI WW Frankfurt
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-03-13

    Pay. Date : 2015-03-06

    DMF Number : 16972

    Submission : 2003-11-13

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2014-194 - Rev 01

    Issue Date : 2021-02-18

    Type : Chemical

    Substance Number : 1783

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 17373-1036

    Start Marketing Date : 2017-01-02

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF VMF ASMF arrow-down
    ✖
    Available Reg. Filing : ASMF
    AUDIT
    Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Hydroxyzine Pamoate

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Vietnam Medi-Pharm Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCosma S.p.A.: FDA-approved API manufacturing with 300+ tons capacity, serving pharma and animal health industries worldwide.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-09-28

    Pay. Date : 2013-09-24

    DMF Number : 4514

    Submission : 1982-04-16

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 218MF11037

    Registrant's Address : Via Colleoni 15/17, 24040 Ciserano(BG)・Italy

    Initial Date of Registration : 2006-12-28

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 51604-0004

    Start Marketing Date : 2009-10-14

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF ASMF arrow-down
    ✖
    Available Reg. Filing : ASMF
    AUDIT
    Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Ketoprofen

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Vietnam Medi-Pharm Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCosma S.p.A.: FDA-approved API manufacturing with 300+ tons capacity, serving pharma and animal health industries worldwide.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-10-28

    Pay. Date : 2015-03-27

    DMF Number : 7599

    Submission : 1988-07-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-053 - Rev 03

    Issue Date : 2020-04-21

    Type : Chemical

    Substance Number : 922

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 51604-0011

    Start Marketing Date : 2018-11-26

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF VMF Others AUDIT
    Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Metoclopramide Hydrochloride

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPhI WW Frankfurt
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-100 - Rev 00

    Issue Date : 2024-03-28

    Type : Chemical

    Substance Number : 674

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 221MF10057

    Registrant's Address : VIALE DEL GHISALLO, 20 20151 MILAN ITALY

    Initial Date of Registration : 2009-03-19

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
    Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Propranolol Hydrochloride

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Vietnam Medi-Pharm Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCosma S.p.A.: FDA-approved API manufacturing with 300+ tons capacity, serving pharma and animal health industries worldwide.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-01-29

    Pay. Date : 2015-01-22

    DMF Number : 4104

    Submission : 1981-02-27

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 221MF10278

    Registrant's Address : Via Colleoni 15/17, 24040 Ciserano (BG)・Italy

    Initial Date of Registration : 2009-12-18

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 51604-0002

    Start Marketing Date : 2009-10-14

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF ASMF arrow-down
    ✖
    Available Reg. Filing : ASMF
    AUDIT
    Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Torsemide

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Vietnam Medi-Pharm Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCosma S.p.A.: FDA-approved API manufacturing with 300+ tons capacity, serving pharma and animal health industries worldwide.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15562

    Submission : 2001-07-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2006-287 - Rev 03

    Issue Date : 2020-01-16

    Type : Chemical

    Substance Number : 2132

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 51604-0020

    Start Marketing Date : 2009-10-14

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF ASMF arrow-down
    ✖
    Available Reg. Filing : ASMF
    AUDIT
    Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Etodolac

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPhI WW Frankfurt
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 11359

    Submission : 1995-02-20

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 17373-0186

    Start Marketing Date : 2017-01-02

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF ASMF arrow-down
    ✖
    Available Reg. Filing : ASMF
    AUDIT
    Company Banner

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

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    KEY PRODUCTS

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    Inspections and registrations

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    ABOUT THIS PAGE

    Contact Cosma and get a quotation

    Cosma is a supplier offers 31 products (APIs, Excipients or Intermediates).

    Find a price of Amisulpride bulk with DMF, CEP offered by Cosma

    Find a price of Hydroxyzine Pamoate bulk with DMF, JDMF offered by Cosma

    Find a price of Ketoprofen bulk with DMF, CEP offered by Cosma

    Find a price of Propranolol Hydrochloride bulk with DMF, JDMF offered by Cosma

    Find a price of Torsemide bulk with DMF, CEP offered by Cosma

    Find a price of Cetirizine Dihydrochloride bulk with DMF offered by Cosma

    Find a price of Diclofenac bulk with DMF offered by Cosma

    Find a price of Gliclazide bulk with DMF offered by Cosma

    Find a price of Hydroxyzine Hydrochloride bulk with DMF offered by Cosma

    Find a price of Labetalol Hydrochloride bulk with DMF offered by Cosma

    Find a price of Metoclopramide Hydrochloride bulk with DMF offered by Cosma

    Find a price of Milnacipran HCl bulk with DMF offered by Cosma

    Find a price of Milnacipran Hydrochloride bulk with DMF offered by Cosma

    Find a price of Oxaprozin bulk with DMF offered by Cosma

    Find a price of Pyrantel Pamoate bulk with DMF offered by Cosma

    Find a price of Ranolazine bulk with DMF offered by Cosma

    Find a price of Rifaximin bulk with CEP offered by Cosma

    Find a price of Torsemide bulk with DMF offered by Cosma

    Find a price of Carprofen bulk offered by Cosma

    Find a price of Cloperastine bulk offered by Cosma

    Find a price of Cloperastine Fendizoate bulk offered by Cosma

    Find a price of Diclofenac Epolamine bulk offered by Cosma

    Find a price of Firocoxib bulk offered by Cosma

    Find a price of Glipizide bulk offered by Cosma

    Find a price of Lercanidipine bulk offered by Cosma

    Find a price of Levodropropizine bulk offered by Cosma

    Find a price of Oclacitinib Maleate bulk offered by Cosma

    Find a price of Proglumide bulk offered by Cosma

    Find a price of Sulfinpyrazone bulk offered by Cosma

    Find a price of Tiropramide Hydrochloride bulk offered by Cosma

    Find a price of Viloxazine Hydrochloride bulk offered by Cosma

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