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    Company profile for Amphastar Pharmaceuticals

    Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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    DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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    HTL Biotechnology is a French biotech & a global leader in the responsible development & production of pharma-grade biopolymers.

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    EVENTS

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

    EXCIPIENTS

    INSPECTIONS & REGISTRATIONS

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    About

    Amphastar Pharmaceuticals, Inc., headquartered in Rancho Cucamonga, California, established in 1996, is a recognized specialty pharmaceutical company that uses state-of-the-art, cGMP compliant facilities to develop, manufacture, and market injectable and inhalation products. In addition to the Corporate Headquarters, Amphastar has five manufacturing facilities located in the United States, China and Europe along with a sta...
    Amphastar Pharmaceuticals, Inc., headquartered in Rancho Cucamonga, California, established in 1996, is a recognized specialty pharmaceutical company that uses state-of-the-art, cGMP compliant facilities to develop, manufacture, and market injectable and inhalation products. In addition to the Corporate Headquarters, Amphastar has five manufacturing facilities located in the United States, China and Europe along with a state-of-the-art New Drug Research Center. Amphastar and its subsidiaries each have their own distinct focus that they skillfully bring together to meet the varied needs of the pharmaceutical industry.

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    CONTACT DETAILS

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    Amphastar PharmaceuticalsUnited_States_of_America Flag
    Country
    Country
    U.S.A
    Address
    Address
    11570 6th Street, Rancho Cucamonga, California 91730
    Telephone
    Telephone
    1-800-423-4136
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://amphastar.com/
    Linkedin
    Linkedin
    youtube
    YouTube
    Twitter
    Twitter

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    Events

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    NEWS #PharmaBuzz

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    Amphastar Announces FDA Approval For Teriparatide Injection
    Amphastar Announces FDA Approval For Teriparatide Injection

    15 Dec 2025

    // PHARMIWEB

    https://www.pharmiweb.com/press-release/2025-12-15/amphastar-announces-fda-approval-for-teriparatide-injection

    PHARMIWEB
    15 Dec 2025
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    Amphastar Pharms’ Generics Teriparatide Receives Approval in US
    Amphastar Pharms’ Generics Teriparatide Receives Approval in US

    12 Dec 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213641

    FDA
    12 Dec 2025
    Share Share
    Amphastar Pharma Presents at 37th Piper Sandler Conference
    Amphastar Pharma Presents at 37th Piper Sandler Conference

    24 Nov 2025

    // PHARMIWEB

    https://www.pharmiweb.com/press-release/2025-11-24/amphastar-pharmaceuticals-to-present-at-the-37th-annual-piper-sandler-healthcare-conference

    PHARMIWEB
    24 Nov 2025
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    Amphastar Pharma at Jefferies Global Healthcare Conference
    Amphastar Pharma at Jefferies Global Healthcare Conference

    12 Nov 2025

    // PHARMIWEB

    https://www.pharmiweb.com/press-release/2025-11-12/amphastar-pharmaceuticals-to-present-at-the-jefferies-global-healthcare-conference

    PHARMIWEB
    12 Nov 2025
    Share Share
    Amphastar Pharma Discloses Q3 2025 Financial Results
    Amphastar Pharma Discloses Q3 2025 Financial Results

    06 Nov 2025

    // PHARMIWEB

    https://www.pharmiweb.com/press-release/2025-11-06/amphastar-pharmaceuticals-reports-financial-results-for-the-three-months-ended-september-30-2025

    PHARMIWEB
    06 Nov 2025
    Share Share
    Amphastar Pharma To Unveil Q3 Earnings, Host Call On Nov 6, 2025
    Amphastar Pharma To Unveil Q3 Earnings, Host Call On Nov 6, 2025

    27 Oct 2025

    // PHARMIWEB

    https://www.pharmiweb.com/press-release/2025-10-27/amphastar-pharmaceuticals-to-release-third-quarter-earnings-and-hold-conference-call-on-november-6th

    PHARMIWEB
    27 Oct 2025
    Share Share

    ALL APIs

    read-moreClick the button for full data set
    read-moreClick the button for full data set

    01

    Beclomethasone Dipropionate

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

    Biotech Showcase
    Not Confirmed
    arrow

    Beclomethasone Dipropionate

    U.S.A

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

    arrow
    Biotech Showcase
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-01-05

    Pay. Date : 2014-03-14

    DMF Number : 27837

    Submission : 2014-03-06

    Status : Active

    Type : II

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

    NDC Package Code : 52221-105

    Start Marketing Date : 2013-12-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER, FOR SUSPENSION (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Product
    Web Link

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    #PipelineProspector

    Market
    Place

    02

    Fluticasone Propionate

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

    Biotech Showcase
    Not Confirmed
    arrow

    Fluticasone Propionate

    U.S.A

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

    arrow
    Biotech Showcase
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-10-02

    Pay. Date : 2015-07-10

    DMF Number : 29454

    Submission : 2015-06-29

    Status : Active

    Type : II

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

    NDC Package Code : 52221-106

    Start Marketing Date : 2013-12-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : INJECTION, POWDER, FOR SUSPENSION (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

    Product
    Web Link

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    Market
    Place

    03

    Heparin Sodium

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

    Biotech Showcase
    Not Confirmed
    arrow

    Heparin Sodium

    U.S.A

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

    arrow
    Biotech Showcase
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-06-10

    Pay. Date : 2012-12-12

    DMF Number : 26059

    Submission : 2012-05-25

    Status : Active

    Type : II

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

    NDC Package Code : 52221-123

    Start Marketing Date : 2018-12-04

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (5kg/5kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
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    Market
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    04

    Heparin Sodium

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

    Biotech Showcase
    Not Confirmed
    arrow

    Heparin Sodium

    U.S.A

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

    arrow
    Biotech Showcase
    Not Confirmed
    • 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 : 2013-07-30

    Pay. Date : 2012-12-12

    DMF Number : 26070

    Submission : 2012-06-15

    Status : Active

    Type : II

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

    NDC Package Code : 52221-101

    Start Marketing Date : 2010-04-12

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

    Product
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    Market
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    05

    Insulin (Human) Recombinant

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

    Biotech Showcase
    Not Confirmed
    arrow

    Insulin (Human) Recombinant

    U.S.A

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

    arrow
    Biotech Showcase
    Not Confirmed
    • 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 : 15262

    Submission : 2001-02-05

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    blank

    Product
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    Stock Recap
    #PipelineProspector

    Market
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    06

    Ipratropium Bromide

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

    Biotech Showcase
    Not Confirmed
    arrow

    Ipratropium Bromide

    U.S.A

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

    arrow
    Biotech Showcase
    Not Confirmed
    • 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 : 2023-03-16

    Pay. Date : 2022-11-04

    DMF Number : 31036

    Submission : 2017-11-28

    Status : Active

    Type : II

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

    NDC Package Code : 52221-108

    Start Marketing Date : 2014-07-21

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

    Product
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    Stock Recap
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    Market
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    07

    Isoproterenol Hydrochloride

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

    Biotech Showcase
    Not Confirmed
    arrow

    Isoproterenol Hydrochloride

    U.S.A

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

    arrow
    Biotech Showcase
    Not Confirmed
    • 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 : 2016-01-13

    Pay. Date : 2015-11-16

    DMF Number : 29876

    Submission : 2015-11-09

    Status : Active

    Type : II

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

    NDC Package Code : 52221-112

    Start Marketing Date : 2015-06-02

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Medroxyprogesterone Acetate

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

    Biotech Showcase
    Not Confirmed
    arrow

    Medroxyprogesterone Acetate

    U.S.A

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

    arrow
    Biotech Showcase
    Not Confirmed
    • 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 : 2022-02-14

    Pay. Date : 2021-09-30

    DMF Number : 32282

    Submission : 2018-02-08

    Status : Active

    Type : II

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

    NDC Package Code : 52221-118

    Start Marketing Date : 2016-10-24

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Protamine Sulfate

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

    Biotech Showcase
    Not Confirmed
    arrow

    Protamine Sulfate

    U.S.A

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

    arrow
    Biotech Showcase
    Not Confirmed
    • 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 : 2022-10-19

    Pay. Date : 2022-10-11

    DMF Number : 30429

    Submission : 2016-09-16

    Status : Active

    Type : II

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

    NDC Package Code : 52221-110

    Start Marketing Date : 2015-07-10

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
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    10

    Salmeterol Xinafoate

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

    Biotech Showcase
    Not Confirmed
    arrow

    Salmeterol Xinafoate

    U.S.A

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

    arrow
    Biotech Showcase
    Not Confirmed
    • 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 : 2015-11-06

    Pay. Date : 2015-08-21

    DMF Number : 29491

    Submission : 2015-08-11

    Status : Active

    Type : II

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

    NDC Package Code : 52221-109

    Start Marketing Date : 2014-09-29

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (0.4kg/.4kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

    Product
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    ABOUT THIS PAGE

    Contact AMPHASTAR NANJING PHARMACEUTICALS INC and get a quotation

    AMPHASTAR NANJING PHARMACEUTICALS INC is a supplier offers 30 products (APIs, Excipients or Intermediates).

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