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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Optimus Pharma

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    Optimus Pharma
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    Country
    Country
    India
    Address
    Address
    2nd Floor, Sy No. 37/A & 37/P, Plot No. 6P, Signature Towers, Kothaguda, Kondapur, Hyderabad – 500 084, Telangana
    Telephone
    Telephone
    040-33889898
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://optimuspharma.com/
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    Linkedin
    https://www.linkedin.com/company/optimus-pharma/
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    Twitter

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    Pregabalin

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    USDMF

    Found USDMF

    30968
    Active
    PREGABALIN
    2016-12-15
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-126 - Rev 00
    Valid
    Pregabalin, Route code: OP-PGN
    2023-03-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0182
    Valid
    Pregabalin (IH)/EP
    2022-11-03
    Application Number
    30968
    R0-CEP 2021-126 - Rev 00
    Indian CDSCO WC-0182
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    PREGABALIN
    Pregabalin, Route code: OP-PGN
    Pregabalin (IH)/EP
    Issue/Submission Date
    2016-12-15
    2023-03-21
    2022-11-03
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    Rifaximin

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    USDMF

    Found USDMF

    34387
    Active
    RIFAXIMIN
    2020-06-08
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-303 - Rev 01
    Valid
    Rifaximin
    2022-06-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0182
    Valid
    Rifaximin (Ph. Eur.)
    2022-11-03
    Application Number
    34387
    R0-CEP 2020-303 - Rev 01
    Indian CDSCO WC-0182
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    RIFAXIMIN
    Rifaximin
    Rifaximin (Ph. Eur.)
    Issue/Submission Date
    2020-06-08
    2022-06-29
    2022-11-03
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    Rivaroxaban

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    USDMF

    Found USDMF

    28790
    Active
    4-(4-AMINOPHENYL) MORPHOLIN-3-ONE [...
    2014-10-30
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-201 - Rev 00
    Valid
    Rivaroxaban
    2022-10-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0182
    Valid
    Rivaroxaban IH
    2022-11-03
    Application Number
    28790
    R0-CEP 2021-201 - Rev 00
    Indian CDSCO WC-0182
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    4-(4-AMINOPHENYL) MORPHOLIN-3-ONE [...
    Rivaroxaban
    Rivaroxaban IH
    Issue/Submission Date
    2014-10-30
    2022-10-19
    2022-11-03
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    Solifenacin Succinate

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    USDMF

    Found USDMF

    29278
    Active
    (S)-1-PHENYL-1,2,3,4-TETRAHYDRO-2-I...
    2015-04-13
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-032 - Rev 01
    Valid
    Solifenacin succinate
    2022-04-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0182
    Valid
    Solifenacin Succinate (IH/EP)
    2022-11-03
    Application Number
    29278
    R0-CEP 2019-032 - Rev 01
    Indian CDSCO WC-0182
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    (S)-1-PHENYL-1,2,3,4-TETRAHYDRO-2-I...
    Solifenacin succinate
    Solifenacin Succinate (IH/EP)
    Issue/Submission Date
    2015-04-13
    2022-04-11
    2022-11-03
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    Dimethyl Fumarate

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    USDMF

    Found USDMF

    29632
    Active
    DIMETHYL FUMARATE
    2015-11-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0182
    Valid
    Dimethyl Fumarate (IH)
    2022-11-03
    Application Number
    29632
    Indian CDSCO WC-0182
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    DIMETHYL FUMARATE
    Dimethyl Fumarate (IH)
    Issue/Submission Date
    2015-11-03
    2022-11-03
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    Dithranol

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2018-032 - Rev 01
    Valid
    Dithranol
    2022-09-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0182
    Valid
    Dithranol EP
    2022-11-03
    Application Number
    R0-CEP 2018-032 - Rev 01
    Indian CDSCO WC-0182
    Status
    Valid
     
    Valid
    2025-07-02
    Filing Details
    Dithranol
    Dithranol EP
    Issue/Submission Date
    2022-09-09
    2022-11-03
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    Fenticonazole Nitrate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2020-046 - Rev 02
    Valid
    Fenticonazole nitrate, FCZ code pro...
    2024-03-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0182
    Valid
    Fenticonazole Nitrate (Ph.Eur)
    2022-11-03
    Application Number
    CEP 2020-046 - Rev 02
    Indian CDSCO WC-0182
    Status
    Valid
     
    Valid
    2025-07-02
    Filing Details
    Fenticonazole nitrate, FCZ code pro...
    Fenticonazole Nitrate (Ph.Eur)
    Issue/Submission Date
    2024-03-04
    2022-11-03
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    Linezolid

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    USDMF

    Found USDMF

    35134
    Active
    LINEZOLID
    2020-12-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0182
    Valid
    Linezolid (IH/USP)
    2022-11-03
    Application Number
    35134
    Indian CDSCO WC-0182
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    LINEZOLID
    Linezolid (IH/USP)
    Issue/Submission Date
    2020-12-25
    2022-11-03
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    Penicillamine

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    USDMF

    Found USDMF

    32411
    Active
    PENICILLAMINE
    2018-07-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0182
    Valid
    D-Penicillamine IH
    2022-11-03
    Application Number
    32411
    Indian CDSCO WC-0182
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    PENICILLAMINE
    D-Penicillamine IH
    Issue/Submission Date
    2018-07-27
    2022-11-03
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    Pirfenidone

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    USDMF

    Found USDMF

    32015
    Active
    PIRFENIDONE
    2017-09-23
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-007 - Rev 01
    Valid
    Pirfenidone
    2022-03-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32015
    R0-CEP 2018-007 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    PIRFENIDONE
    Pirfenidone
    Issue/Submission Date
    2017-09-23
    2022-03-30
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    Teriflunomide

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    USDMF

    Found USDMF

    29825
    Active
    5-METHYL-ISOXAZOLE-4-CARBOXYLIC ACI...
    2015-09-18
    CEP/COS

    Found CEP/COS

    CEP 2022-254 - Rev 00
    Valid
    Teriflunomide
    2024-02-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29825
    CEP 2022-254 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    5-METHYL-ISOXAZOLE-4-CARBOXYLIC ACI...
    Teriflunomide
    Issue/Submission Date
    2015-09-18
    2024-02-28
    ASK
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    Tioconazole

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2020-068 - Rev 02
    Valid
    Tioconazole
    2024-02-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0182
    Valid
    Tioconazole (Ph.Eur)
    2022-11-03
    Application Number
    CEP 2020-068 - Rev 02
    Indian CDSCO WC-0182
    Status
    Valid
     
    Valid
    2025-07-02
    Filing Details
    Tioconazole
    Tioconazole (Ph.Eur)
    Issue/Submission Date
    2024-02-23
    2022-11-03
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    Pregabalin

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    See Less

    USDMF

    Found USDMF

    34934
    Active
    PREGABALIN (ROUTE CODE - "OP-PGN")
    2020-06-15
    CEP/COS

    Caution CEP/COS

    R0-CEP 2017-016 - Rev 00
    Withdrawn by Holder
    Pregabalin
    2018-03-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34934
    R0-CEP 2017-016 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Filing Details
    PREGABALIN (ROUTE CODE - "OP-PGN")
    Pregabalin
    Issue/Submission Date
    2020-06-15
    2018-03-19
    ASK
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    17-Iodoandrosta-5,16-Dien-3Beta-Ol

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    USDMF

    Found USDMF

    28789
    Active
    17-IODO-ANDROSTA-5,16-DIENE-3BETA-O...
    2014-10-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28789
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    17-IODO-ANDROSTA-5,16-DIENE-3BETA-O...
    Issue/Submission Date
    2014-10-30
    ASK
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    3-Pyridyldiethylborane

    PDF Supplier PDF
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    USDMF

    Found USDMF

    28806
    Active
    3-DIETHYLBORANYL-PYRIDINE (ABIRATER...
    2014-11-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28806
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    3-DIETHYLBORANYL-PYRIDINE (ABIRATER...
    Issue/Submission Date
    2014-11-05
    ASK
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    Aminocaproic Acid

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    USDMF

    Found USDMF

    33407
    Active
    AMINOCAPROIC ACID
    2018-12-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33407
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    AMINOCAPROIC ACID
    Issue/Submission Date
    2018-12-19
    ASK
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    Amorolfine Hydrochloride

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-046 - Rev 00
    Valid
    Amorolfine hydrochloride
    2023-05-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2021-046 - Rev 00
    Status
    Valid
     
    Filing Details
    Amorolfine hydrochloride
    Issue/Submission Date
    2023-05-02
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    Apixaban

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36651
    Active
    APIXABAN
    2022-03-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36651
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    APIXABAN
    Issue/Submission Date
    2022-03-31
    ASK
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    Atazanavir

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29824
    Active
    (2S)-2-[(METHOXYCARBONYL)AMINO]-3,3...
    2015-09-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29824
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    (2S)-2-[(METHOXYCARBONYL)AMINO]-3,3...
    Issue/Submission Date
    2015-09-18
    ASK
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    Bempedoic Acid

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    USDMF

    Found USDMF

    35956
    Active
    BEMPEDOIC ACID
    2021-06-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35956
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BEMPEDOIC ACID
    Issue/Submission Date
    2021-06-11
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    Bisoxatin acetate

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0182
    Valid
    Bisoxatin acetate IH
    2022-11-03
    Application Number
    Indian CDSCO WC-0182
    Status
     
    Valid
    2025-07-02
    Filing Details
    Bisoxatin acetate IH
    Issue/Submission Date
    2022-11-03
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    Brivaracetam

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    USDMF

    Found USDMF

    36649
    Active
    BRIVARACETAM
    2022-04-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36649
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BRIVARACETAM
    Issue/Submission Date
    2022-04-29
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    Bucillamine

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    USDMF

    Found USDMF

    36652
    Active
    BUCILLAMINE
    2021-12-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36652
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BUCILLAMINE
    Issue/Submission Date
    2021-12-23
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    Dabigatran Etexilate Mesylate

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    USDMF

    Found USDMF

    35132
    Active
    DABIGATRAN ETEXILATE MESYLATE
    2020-12-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35132
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DABIGATRAN ETEXILATE MESYLATE
    Issue/Submission Date
    2020-12-29
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    Dapagliflozin

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    USDMF

    Found USDMF

    37089
    Active
    DAPAGLIFLOZIN
    2022-05-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37089
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DAPAGLIFLOZIN
    Issue/Submission Date
    2022-05-03
    ASK
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    Dapoxetine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0182
    Valid
    Dapoxetine Hydrochloride (IH)
    2022-11-03
    Application Number
    Indian CDSCO WC-0182
    Status
     
    Valid
    2025-07-02
    Filing Details
    Dapoxetine Hydrochloride (IH)
    Issue/Submission Date
    2022-11-03
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    Dexlansoprazole

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    USDMF

    Found USDMF

    35135
    Active
    DEXLANSOPRAZOLE
    2020-12-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35135
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DEXLANSOPRAZOLE
    Issue/Submission Date
    2020-12-30
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    Eletriptan Hydrobromide

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    USDMF

    Found USDMF

    29890
    Active
    (R)-5-BROMO-3-[(1-METHYL-2-PYRROLID...
    2015-10-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29890
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    (R)-5-BROMO-3-[(1-METHYL-2-PYRROLID...
    Issue/Submission Date
    2015-10-06
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    Eltrombopag

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    USDMF

    Found USDMF

    39106
    Active
    ELTROMBOPAG OLAMINE
    2023-11-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39106
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ELTROMBOPAG OLAMINE
    Issue/Submission Date
    2023-11-01
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    Favipiravir

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    USDMF

    Found USDMF

    35927
    Active
    FAVIPIRAVIR
    2021-05-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35927
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FAVIPIRAVIR
    Issue/Submission Date
    2021-05-15
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    Linagliptin

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    USDMF

    Found USDMF

    36650
    Active
    LINAGLIPTIN
    2022-04-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36650
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LINAGLIPTIN
    Issue/Submission Date
    2022-04-30
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    Lornoxicam

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0182
    Valid
    Lornoxicam (IH)
    2022-11-03
    Application Number
    Indian CDSCO WC-0182
    Status
     
    Valid
    2025-07-02
    Filing Details
    Lornoxicam (IH)
    Issue/Submission Date
    2022-11-03
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    Mebendazole

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    USDMF

    Found USDMF

    32016
    Active
    MEBENDAZOLE FORM-A
    2017-09-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32016
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MEBENDAZOLE FORM-A
    Issue/Submission Date
    2017-09-07
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    Mesalazine

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    USDMF

    Found USDMF

    35136
    Active
    MESALAMINE
    2020-12-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35136
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MESALAMINE
    Issue/Submission Date
    2020-12-28
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    Midodrine

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    USDMF

    Found USDMF

    36272
    Active
    MIDODRINE HYDROCHLORIDE
    2021-09-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36272
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MIDODRINE HYDROCHLORIDE
    Issue/Submission Date
    2021-09-21
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    Mirabegron

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    USDMF

    Found USDMF

    28420
    Active
    (1R)-2-[(2-(4-NITROPHENYL) ETHYL] A...
    2014-06-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28420
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    (1R)-2-[(2-(4-NITROPHENYL) ETHYL] A...
    Issue/Submission Date
    2014-06-25
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    Mirabegron

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    USDMF

    Found USDMF

    29889
    Active
    (R) -ALPHA-[[[2-(4-NITRO-PHENYL)-ET...
    2015-10-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29889
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    (R) -ALPHA-[[[2-(4-NITRO-PHENYL)-ET...
    Issue/Submission Date
    2015-10-06
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    Molnupiravir

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    USDMF

    Found USDMF

    36078
    Active
    MOLNUPIRAVIR
    2021-06-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36078
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MOLNUPIRAVIR
    Issue/Submission Date
    2021-06-30
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    Nirmatrelvir

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    USDMF

    Found USDMF

    37393
    Active
    NIRMATRELVIR
    2022-07-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37393
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    NIRMATRELVIR
    Issue/Submission Date
    2022-07-29
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    Obeticholic Acid

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    USDMF

    Found USDMF

    33960
    Active
    OBETICHOLIC ACID
    2019-11-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33960
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    OBETICHOLIC ACID
    Issue/Submission Date
    2019-11-07
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    Rasagiline Tartrate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0182
    Valid
    Rasagiline Tartrate IH
    2022-11-03
    Application Number
    Indian CDSCO WC-0182
    Status
     
    Valid
    2025-07-02
    Filing Details
    Rasagiline Tartrate IH
    Issue/Submission Date
    2022-11-03
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    Rivaroxaban

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    USDMF

    Found USDMF

    32846
    Active
    RIVAROXABAN
    2019-02-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32846
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    RIVAROXABAN
    Issue/Submission Date
    2019-02-22
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    Safinamide Mesylate

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    USDMF

    Found USDMF

    35138
    Active
    SAFINAMIDE MESYLATE
    2020-09-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35138
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SAFINAMIDE MESYLATE
    Issue/Submission Date
    2020-09-08
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    Sitagliptin Phosphate

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    USDMF

    Found USDMF

    36139
    Active
    SITAGLIPTIN PHOSPHATE MONOHYDRATE
    2021-09-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36139
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SITAGLIPTIN PHOSPHATE MONOHYDRATE
    Issue/Submission Date
    2021-09-23
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    Solifenacin Succinate

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    USDMF

    Found USDMF

    30965
    Active
    SOLIFENACIN SUCCINATE
    2016-12-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30965
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SOLIFENACIN SUCCINATE
    Issue/Submission Date
    2016-12-09
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    Tafamidis Meglumine

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    USDMF

    Found USDMF

    37177
    Active
    TAFAMIDIS MEGLUMINE
    2022-08-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37177
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TAFAMIDIS MEGLUMINE
    Issue/Submission Date
    2022-08-16
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    Teriflunomide

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    USDMF

    Found USDMF

    36653
    Active
    TERIFLUNOMIDE
    2021-12-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36653
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TERIFLUNOMIDE
    Issue/Submission Date
    2021-12-23
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    Upadacitinib

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    USDMF

    Found USDMF

    38051
    Active
    UPADACITINIB HEMIHYDRATE
    2023-02-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38051
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    UPADACITINIB HEMIHYDRATE
    Issue/Submission Date
    2023-02-09
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    Vonoprazan Fumarate

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    USDMF

    Found USDMF

    37045
    Active
    VONOPRAZAN FUMARATE
    2022-04-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37045
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    VONOPRAZAN FUMARATE
    Issue/Submission Date
    2022-04-28
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    Zileuton

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    USDMF

    Found USDMF

    35137
    Active
    ZILEUTON
    2020-12-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35137
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ZILEUTON
    Issue/Submission Date
    2020-12-26
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