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    Company profile for Optimus Pharma

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    EVENTS

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    About

    Optimus is one of the fastest-growing pharmaceutical companies with 16 years of experience in providing the best quality of API, Intermediates & Finished formulations in Global markets. Our aim from day one has been to provide and ensure better healthcare across the globe through our research, Innovations, affordable products & manufacturing excellence. Optimus was established to provide quality & affordable pharmaceutical pr...
    Optimus is one of the fastest-growing pharmaceutical companies with 16 years of experience in providing the best quality of API, Intermediates & Finished formulations in Global markets. Our aim from day one has been to provide and ensure better healthcare across the globe through our research, Innovations, affordable products & manufacturing excellence. Optimus was established to provide quality & affordable pharmaceutical products in the global markets.

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    CONTACT DETAILS

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    Optimus Pharmaindia-flag Flag
    Country
    Country
    India
    Address
    Address
    2nd Floor, Sy No. 37/A & 37/P, Plot No. 6P, Signature Towers, Kothaguda, Konda...
    Telephone
    Telephone
    040-33889898
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://optimuspharma.com/
    Linkedin
    Linkedin
    https://www.linkedin.com/company/optimus-pharma/
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    Twitter

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    PEGS Boston Summit

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    NEWS #PharmaBuzz

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    Optimus Pharma's Generic Brexpiprazole Receives Approval in the U.S.
    Optimus Pharma's Generic Brexpiprazole Receives Approval in the U.S.

    25 Oct 2023

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213758

    FDA
    25 Oct 2023
    Share Share
    Optimus' Generic Obeticholic Acid Receives Approval in the U.S.
    Optimus' Generic Obeticholic Acid Receives Approval in the U.S.

    20 Jul 2023

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214935

    FDA
    20 Jul 2023
    Share Share
    Optimus' Generic Safinamide Receives Approval in the U.S.
    Optimus' Generic Safinamide Receives Approval in the U.S.

    12 Jan 2023

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216020

    FDA
    12 Jan 2023
    Share Share
    Optimus' Generic Safinamide Mesylate Receives Approval in the U.S.
    Optimus' Generic Safinamide Mesylate Receives Approval in the U.S.

    12 Jan 2023

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216020

    FDA
    12 Jan 2023
    Share Share
    PAG-led API platform completes acquisition of controlling stake in Optimus
    PAG-led API platform completes acquisition of controlling stake in Optimus

    26 Sep 2022

    // PHARMABIZ

    http://www.pharmabiz.com/NewsDetails.aspx?aid=153458&sid=2

    PHARMABIZ
    26 Sep 2022
    Share Share
    Optimus' Generic Aminocaproic Acid Receives Approval in the U.S.
    Optimus' Generic Aminocaproic Acid Receives Approval in the U.S.

    14 Sep 2022

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213944

    FDA
    14 Sep 2022
    Share Share

    ALL APIs

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

    01

    Pregabalin

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Pregabalin

    India

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-02-16

    Pay. Date : 2016-09-30

    DMF Number : 30968

    Submission : 2016-12-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2021-126 - Rev 00

    Issue Date : 2023-03-21

    Type : Chemical

    Substance Number : 2777

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-12

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0182

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 59285-030

    Start Marketing Date : 2020-07-20

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Taewang Mulsan Co., Ltd.

    Registration Date : 2016-05-17

    Registration Number : Number 4692-13-ND(2)

    Manufacturer Name : Optimus Drugs (P) Ltd

    Manufacturer Address : Sy.No.239 & 240, Dothigudem Village, Pochampally Mandal, Nalgonda District, Andhra Pradesh, India

     VMF Others AUDIT arrow-down
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    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    Rifaximin

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Rifaximin

    India

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

    arrow
    PEGS Boston Summit
    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 : 2020-09-14

    Pay. Date : 2020-07-30

    DMF Number : 34387

    Submission : 2020-06-08

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2020-303 - Rev 01

    Issue Date : 2022-06-29

    Type : Chemical

    Substance Number : 2362

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-12

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0182

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 59285-008

    Start Marketing Date : 2015-05-11

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Aging Life Science Co., Ltd.

    Registration Date : 2022-01-20

    Registration Number : 20220120-209-J-1217

    Manufacturer Name : Optimus Drugs Private Limited

    Manufacturer Address : Unit-I, Survey No. 239 & 240, Dothigudem Village, Pochampally Mandal, Yadadri-Bhuvanagiri District – 508 284, Telangana, India

     VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Rivaroxaban

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Rivaroxaban

    India

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

    arrow
    PEGS Boston Summit
    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 : 2019-05-01

    Pay. Date : 2019-03-06

    DMF Number : 32846

    Submission : 2019-02-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2021-201 - Rev 00

    Issue Date : 2022-10-19

    Type : Chemical

    Substance Number : 2932

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-12

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0182

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 59285-009

    Start Marketing Date : 2015-08-25

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    Sitagliptin Phosphate

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Sitagliptin Phosphate

    India

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

    arrow
    PEGS Boston Summit
    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 : 2021-11-09

    Pay. Date : 2021-09-16

    DMF Number : 36139

    Submission : 2021-09-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-273 - Rev 00

    Issue Date : 2025-05-23

    Type : Chemical

    Substance Number : 2778

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-12

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0182

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 59285-042

    Start Marketing Date : 2021-08-23

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Solifenacin Succinate

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Solifenacin Succinate

    India

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

    arrow
    PEGS Boston Summit
    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 : 2017-01-30

    Pay. Date : 2016-09-29

    DMF Number : 30965

    Submission : 2016-12-09

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2019-032 - Rev 03

    Issue Date : 2025-08-20

    Type : Chemical

    Substance Number : 2779

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-12

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0182

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 59285-006

    Start Marketing Date : 2015-04-02

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Jeil Pharmaceutical Co., Ltd.

    Registration Date : 2015-11-27

    Registration Number : Number 3595-4-ND(1)

    Manufacturer Name : Optimus Drugs Private Limited

    Manufacturer Address : Unit-I, Survey No. 239 & 240, Dothigudem Village, Pochampally Mandal, Yadadri Bhuvanagiri District, Pincode 508 284, Telangana State, INDIA.

     VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Teriflunomide

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Teriflunomide

    India

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

    arrow
    PEGS Boston Summit
    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 : 36653

    Submission : 2021-12-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-254 - Rev 00

    Issue Date : 2024-02-28

    Type : Chemical

    Substance Number : 3036

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-12

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0182

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 59285-001

    Start Marketing Date : 2014-04-30

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Dimethyl Fumarate

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Dimethyl Fumarate

    India

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

    arrow
    PEGS Boston Summit
    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 : 2016-03-25

    Pay. Date : 2015-08-31

    DMF Number : 29632

    Submission : 2015-11-03

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-12

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0182

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 59285-003

    Start Marketing Date : 2014-12-07

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Linezolid

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Linezolid

    India

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

    arrow
    PEGS Boston Summit
    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 : 2021-03-03

    Pay. Date : 2021-01-25

    DMF Number : 35134

    Submission : 2020-12-25

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-12

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0182

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 59285-021

    Start Marketing Date : 2020-12-14

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Obeticholic Acid

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Obeticholic Acid

    India

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

    arrow
    PEGS Boston Summit
    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 : 2019-12-26

    Pay. Date : 2019-11-06

    DMF Number : 33960

    Submission : 2019-11-07

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-12

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0182

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 59285-028

    Start Marketing Date : 2019-12-26

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Penicillamine

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Penicillamine

    India

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

    arrow
    PEGS Boston Summit
    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 : 2018-08-30

    Pay. Date : 2018-01-19

    DMF Number : 32411

    Submission : 2018-07-27

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-12

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0182

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 59285-014

    Start Marketing Date : 2017-10-12

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    blank

    Product
    Web Link

    Stock Recap
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    Market
    Place

    Only 10 entries up to this point, click to access all click full view read-more
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