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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Swati Spentose

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    Swati Spentose
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    Country
    Country
    India
    Address
    Address
    114, Marine Chambers, 11 New Marine Lines, Mumbai - 400 020
    Telephone
    Telephone
    +91-22-66332427
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://spentose.com/
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    Lidocaine

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    USDMF

    Found USDMF

    25830
    Active
    LIDOCAINE USP
    2012-02-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-138 - Rev 00
    Valid
    Lidocaine
    2019-10-01
    Japanese DMF

    Found JDMF

    226MF10092
    Lidocaine at 114 Marine Chambers, 1...
    2014-05-14
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0165
    Expired
    Lidocaine (EP/BP/USP)
    2019-07-08
    Application Number
    25830
    R1-CEP 2013-138 - Rev 00
    226MF10092
    Indian CDSCO WC-0165
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Expired
    2022-07-08
    Filing Details
    LIDOCAINE USP
    Lidocaine
    Lidocaine at 114 Marine Chambers, 1...
    Lidocaine (EP/BP/USP)
    Issue/Submission Date
    2012-02-22
    2019-10-01
    2014-05-14
    2019-07-08
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    Prilocaine

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    USDMF

    Found USDMF

    35260
    Active
    PRILOCAINE USP
    2020-10-31
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-347 - Rev 00
    Valid
    Prilocaine
    2022-12-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0165N
    Valid
    Prilocaine EP/BP/USP
    2022-06-15
    Application Number
    35260
    R0-CEP 2020-347 - Rev 00
    Indian CDSCO WC-0165N
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Valid
    2025-07-07
    Filing Details
    PRILOCAINE USP
    Prilocaine
    Prilocaine EP/BP/USP
    Issue/Submission Date
    2020-10-31
    2022-12-09
    2022-06-15
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    Lidocaine Hydrochloride

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    USDMF

    Found USDMF

    25963
    Active
    LIDOCAINE HYDROCHLORIDE USP
    2012-03-06
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-103 - Rev 01
    Valid
    Lidocaine hydrochloride monohydrate
    2023-05-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0165
    Expired
    Lidocaine HCI (EP/BP/USP)
    2019-07-08
    Application Number
    25963
    R1-CEP 2013-103 - Rev 01
    Indian CDSCO WC-0165
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Expired
    2022-07-08
    Filing Details
    LIDOCAINE HYDROCHLORIDE USP
    Lidocaine hydrochloride monohydrate
    Lidocaine HCI (EP/BP/USP)
    Issue/Submission Date
    2012-03-06
    2023-05-10
    2019-07-08
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    Meloxicam

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    USDMF

    Found USDMF

    18837
    Active
    MELOXICAM
    2005-09-30
    CEP/COS

    Found CEP/COS

    CEP 2014-261 - Rev 01
    Valid
    Meloxicam
    2023-10-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0165
    Expired
    Meloxicam (EP/BP/USP)
    2019-07-08
    Application Number
    18837
    CEP 2014-261 - Rev 01
    Indian CDSCO WC-0165
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Expired
    2022-07-08
    Filing Details
    MELOXICAM
    Meloxicam
    Meloxicam (EP/BP/USP)
    Issue/Submission Date
    2005-09-30
    2023-10-27
    2019-07-08
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    Tamsulosin

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    USDMF

    Found USDMF

    36934
    Active
    TAMSULOSIN HYDROCHLORIDE USP
    2022-03-30
    CEP/COS

    Found CEP/COS

    CEP 2022-133 - Rev 00
    Valid
    Tamsulosin hydrochloride
    2023-11-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0165A3
    Expired
    Tamsulosin Hydrochloride USP/EP/BP
    2022-02-25
    Application Number
    36934
    CEP 2022-133 - Rev 00
    Indian CDSCO WC-0165A3
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Expired
    2022-07-07
    Filing Details
    TAMSULOSIN HYDROCHLORIDE USP
    Tamsulosin hydrochloride
    Tamsulosin Hydrochloride USP/EP/BP
    Issue/Submission Date
    2022-03-30
    2023-11-30
    2022-02-25
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    Dutasteride

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    230MF10161
    Dutasteride at 114 Marine Chambers,...
    2018-12-03
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0419
    Expired
    Dutasteride EP/IP
    2018-06-11
    Application Number
    230MF10161
    Indian CDSCO WC-0419
    Status
     
    Expired
    2021-06-10
    Filing Details
    Dutasteride at 114 Marine Chambers,...
    Dutasteride EP/IP
    Issue/Submission Date
    2018-12-03
    2018-06-11
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    Glycopyrronium Bromide

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    USDMF

    Found USDMF

    38550
    Active
    GLYCOPYRROLATE USP
    2023-09-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0165A3
    Expired
    Glycopyrrolate USP/Glycopyrronium B...
    2022-02-25
    Application Number
    38550
    Indian CDSCO WC-0165A3
    Status
    Active
    Fees Unpaid
    N/A
     
    Expired
    2022-07-07
    Filing Details
    GLYCOPYRROLATE USP
    Glycopyrrolate USP/Glycopyrronium B...
    Issue/Submission Date
    2023-09-06
    2022-02-25
    ASK
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    Granisetron Hydrochloride

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    USDMF

    Found USDMF

    35147
    Active
    GRANISETRON HYDROCHLORIDE USP
    2020-08-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0165
    Expired
    Granisetron hydrochloride BP/EPUSP
    2019-07-08
    Application Number
    35147
    Indian CDSCO WC-0165
    Status
    Active
    Fees Unpaid
    N/A
     
    Expired
    2022-07-08
    Filing Details
    GRANISETRON HYDROCHLORIDE USP
    Granisetron hydrochloride BP/EPUSP
    Issue/Submission Date
    2020-08-27
    2019-07-08
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    Melatonin

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    USDMF

    Found USDMF

    34979
    Active
    MELATONIN USP
    2020-08-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0165
    Expired
    Melatonin (BP)
    2019-07-08
    Application Number
    34979
    Indian CDSCO WC-0165
    Status
    Active
    Fees Unpaid
    N/A
     
    Expired
    2022-07-08
    Filing Details
    MELATONIN USP
    Melatonin (BP)
    Issue/Submission Date
    2020-08-08
    2019-07-08
    ASK
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    Pentosan Polysulfate Sodium

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    USDMF

    Found USDMF

    25827
    Active
    PENTOSAN POLYSULFATE SODIUM
    2012-02-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0165
    Expired
    Pentosan Polysulfate Sodium IH
    2019-07-08
    Application Number
    25827
    Indian CDSCO WC-0165
    Status
    Active
    Fees Unpaid
    N/A
     
    Expired
    2022-07-08
    Filing Details
    PENTOSAN POLYSULFATE SODIUM
    Pentosan Polysulfate Sodium IH
    Issue/Submission Date
    2012-02-22
    2019-07-08
    ASK
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    Silodosin

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    36362
    Active
    SILODOSIN
    2023-03-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0165A3
    Expired
    Silodosin IH
    2022-02-25
    Application Number
    36362
    Indian CDSCO WC-0165A3
    Status
    Active
    Fees Unpaid
    N/A
     
    Expired
    2022-07-07
    Filing Details
    SILODOSIN
    Silodosin IH
    Issue/Submission Date
    2023-03-01
    2022-02-25
    ASK
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    Prilocaine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    35334
    Active
    PRILOCAINE HYDROCHLORIDE USP
    2021-01-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35334
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    PRILOCAINE HYDROCHLORIDE USP
    Issue/Submission Date
    2021-01-30
    ASK
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    Diphenhydramine Hydrochloride

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0165A2
    Expired
    Diphenhydramine HCl EP/BP/USP
    2019-07-22
    Application Number
    Indian CDSCO WC-0165A2
    Status
     
    Expired
    2022-07-07
    Filing Details
    Diphenhydramine HCl EP/BP/USP
    Issue/Submission Date
    2019-07-22
    ASK
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    Fluocinolone Acetonide

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0419
    Expired
    Fluocinolone Acetonide USP/EP/IP/BP
    2018-06-11
    Application Number
    Indian CDSCO WC-0419
    Status
     
    Expired
    2021-06-10
    Filing Details
    Fluocinolone Acetonide USP/EP/IP/BP
    Issue/Submission Date
    2018-06-11
    ASK
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    Granisetron Hydrochloride

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0165A2
    Expired
    Granisetron Hydrochloride BP
    2019-07-22
    Application Number
    Indian CDSCO WC-0165A2
    Status
     
    Expired
    2022-07-07
    Filing Details
    Granisetron Hydrochloride BP
    Issue/Submission Date
    2019-07-22
    ASK
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    Halobetasol

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0419
    Expired
    Halobetasol Propionate USP
    2018-06-11
    Application Number
    Indian CDSCO WC-0419
    Status
     
    Expired
    2021-06-10
    Filing Details
    Halobetasol Propionate USP
    Issue/Submission Date
    2018-06-11
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    Metformin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0165
    Expired
    Metformin HCI (EP/BP/USP)
    2019-07-08
    Application Number
    Indian CDSCO WC-0165
    Status
     
    Expired
    2022-07-08
    Filing Details
    Metformin HCI (EP/BP/USP)
    Issue/Submission Date
    2019-07-08
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    Phenytoin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0165
    Expired
    Phenytoin
    2019-07-08
    Application Number
    Indian CDSCO WC-0165
    Status
     
    Expired
    2022-07-08
    Filing Details
    Phenytoin
    Issue/Submission Date
    2019-07-08
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    Phenytoin Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0165
    Expired
    Phenytoin Sodium (BP/EP/USP)
    2019-07-08
    Application Number
    Indian CDSCO WC-0165
    Status
     
    Expired
    2022-07-08
    Filing Details
    Phenytoin Sodium (BP/EP/USP)
    Issue/Submission Date
    2019-07-08
    ASK
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    Piroxicam

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0165
    Expired
    Piroxicam (BP/EP/USP)
    2019-07-08
    Application Number
    Indian CDSCO WC-0165
    Status
     
    Expired
    2022-07-08
    Filing Details
    Piroxicam (BP/EP/USP)
    Issue/Submission Date
    2019-07-08
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    Prilocaine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0165A2
    Expired
    Prilocaine HCL EP/BP/USP
    2019-07-22
    Application Number
    Indian CDSCO WC-0165A2
    Status
     
    Expired
    2022-07-07
    Filing Details
    Prilocaine HCL EP/BP/USP
    Issue/Submission Date
    2019-07-22
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    Alendronate Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    Articaine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    Betamethasone

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    Budesonide

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    Bupivacaine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    Clobetasol Propionate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
    US
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