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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Shilpa Medicare

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    01 Abacavir Sulfate (1)

    02 Abiraterone Acetate (1)

    03 Acebrophylline (1)

    04 Afatinib (1)

    05 Ambroxol Hydrochloride (1)

    06 Anastrozole (2)

    07 Axitinib (1)

    08 Azacitidine (1)

    09 Bendamustine Hydrochloride (1)

    10 Bicalutamide (1)

    11 Bortezomib (2)

    12 Buflomedil (1)

    13 Busulfan (1)

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    27 Dimethyl Fumarate (1)

    28 Dolutegravir Sodium (1)

    29 Duloxetine (1)

    30 Echothiophate Iodide (1)

    31 Eltrombopag (1)

    32 Enzalutamide (1)

    33 Erlotinib Hydrochloride (1)

    34 Fingolimod Hydrochloride (2)

    35 Fludarabine Phosphate (1)

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    37 Glycopyrronium Bromide (1)

    38 Ibrutinib (1)

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    41 Lanthanum Carbonate (1)

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    46 Losartan Potassium (1)

    47 Melphalan Hydrochloride (1)

    48 Montelukast Sodium (1)

    49 Nifedipine (1)

    50 Nilotinib (2)

    51 Nintedanib Esylate (1)

    52 Oxaliplatin (1)

    53 Oxcarbazepine (1)

    54 Palbociclib (1)

    55 Palmitoylethanolamide (1)

    56 Pazopanib Hydrochloride (1)

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    77 Valacyclovir Hydrochloride (1)

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    80 Zoledronic Acid (1)

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    01 Active (45)

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    01 221MF10017 (1)

    02 225MF10084 (1)

    03 226MF10029 (1)

    04 227MF10034 (1)

    05 228MF10125 (1)

    06 229MF10131 (1)

    07 230MF10027 (1)

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    09 304MF10124 (1)

    10 Blank (81)

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    01 WC-0147 (18)

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    Busulfan

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25491
    Active
    BUSULFAN USP
    2011-12-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-339 - Rev 02
    Valid
    Busulfan
    2022-07-20
    Japanese DMF

    Found JDMF

    230MF10027
    Busulfan at Shilpa House, #12-6-214...
    2018-02-15
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147
    Expired
    Busulfan (Ph.Eur/USP)
    2019-07-05
    Application Number
    25491
    R1-CEP 2011-339 - Rev 02
    230MF10027
    Indian CDSCO WC-0147
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    BUSULFAN USP
    Busulfan
    Busulfan at Shilpa House, #12-6-214...
    Busulfan (Ph.Eur/USP)
    Issue/Submission Date
    2011-12-07
    2022-07-20
    2018-02-15
    2019-07-05
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    Capecitabine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    24689
    Active
    CAPECITABINE USP
    2011-03-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-332 - Rev 02
    Valid
    Capecitabine
    2023-02-07
    Japanese DMF

    Found JDMF

    229MF10131
    Capecitabine at Shilpa House, #12-6...
    2017-07-19
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147
    Expired
    Capecitabine (1H)
    2019-07-05
    Application Number
    24689
    R1-CEP 2014-332 - Rev 02
    229MF10131
    Indian CDSCO WC-0147
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    CAPECITABINE USP
    Capecitabine
    Capecitabine at Shilpa House, #12-6...
    Capecitabine (1H)
    Issue/Submission Date
    2011-03-24
    2023-02-07
    2017-07-19
    2019-07-05
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    Gemcitabine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    24136
    Active
    GEMCITABINE HYDROCHLORIDE USP
    2011-03-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-222 - Rev 01
    Valid
    Gemcitabine hydrochloride
    2023-02-23
    Japanese DMF

    Found JDMF

    221MF10017
    Gemcitabine hydrochloride at 10/80,...
    2009-01-13
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0148
    Expired
    Gemcitabine Hydrochloride (USP/Ph. ...
    2019-07-05
    Application Number
    24136
    R1-CEP 2006-222 - Rev 01
    221MF10017
    Indian CDSCO WC-0148
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    GEMCITABINE HYDROCHLORIDE USP
    Gemcitabine hydrochloride
    Gemcitabine hydrochloride at 10/80,...
    Gemcitabine Hydrochloride (USP/Ph. ...
    Issue/Submission Date
    2011-03-04
    2023-02-23
    2009-01-13
    2019-07-05
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    Letrozole

    PDF Supplier PDF
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    USDMF

    Found USDMF

    27489
    Active
    LETROZOLE USP
    2013-09-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-321 - Rev 01
    Valid
    Letrozole
    2022-07-20
    Japanese DMF

    Found JDMF

    226MF10029
    Letrozole at Shilpa House, #12-6-21...
    2014-02-05
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147
    Expired
    Letrozole (USP)
    2019-07-05
    Application Number
    27489
    R1-CEP 2013-321 - Rev 01
    226MF10029
    Indian CDSCO WC-0147
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    LETROZOLE USP
    Letrozole
    Letrozole at Shilpa House, #12-6-21...
    Letrozole (USP)
    Issue/Submission Date
    2013-09-26
    2022-07-20
    2014-02-05
    2019-07-05
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    Temozolomide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23479
    Active
    TEMOZOLOMIDE USP
    2010-01-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-277 - Rev 00
    Valid
    Temozolomide
    2022-07-12
    Japanese DMF

    Found JDMF

    228MF10125
    Temozolomide at Shilpa House, #12-6...
    2016-07-12
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0148
    Expired
    Temozolomide (IH)
    2019-07-05
    Application Number
    23479
    R1-CEP 2016-277 - Rev 00
    228MF10125
    Indian CDSCO WC-0148
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    TEMOZOLOMIDE USP
    Temozolomide
    Temozolomide at Shilpa House, #12-6...
    Temozolomide (IH)
    Issue/Submission Date
    2010-01-22
    2022-07-12
    2016-07-12
    2019-07-05
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    Ambroxol Hydrochloride

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2004-201 - Rev 05
    Valid
    Ambroxol hydrochloride
    2022-07-20
    Japanese DMF

    Found JDMF

    304MF10124
    Ambroxol Hydrochloride at Shilpa Ho...
    2022-08-24
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0148
    Expired
    Ambroxol Hydrochloride (Ph. Eur.)
    2019-07-05
    Application Number
    R1-CEP 2004-201 - Rev 05
    304MF10124
    Indian CDSCO WC-0148
    Status
    Valid
     
    Expired
    2022-07-02
    Filing Details
    Ambroxol hydrochloride
    Ambroxol Hydrochloride at Shilpa Ho...
    Ambroxol Hydrochloride (Ph. Eur.)
    Issue/Submission Date
    2022-07-20
    2022-08-24
    2019-07-05
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    Azacitidine

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    USDMF

    Found USDMF

    27487
    Active
    AZACITIDINE
    2013-09-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF10033
    Azacitidine at Shilpa House, #12-6-...
    2021-02-16
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147
    Expired
    Azacitidine IH
    2019-07-05
    Application Number
    27487
    303MF10033
    Indian CDSCO WC-0147
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    AZACITIDINE
    Azacitidine at Shilpa House, #12-6-...
    Azacitidine IH
    Issue/Submission Date
    2013-09-23
    2021-02-16
    2019-07-05
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    Bicalutamide

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    USDMF

    Found USDMF

    24690
    Active
    BICALUTAMIDE USP
    2011-05-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10084
    Bicalutamide at Shilpa House, #12-6...
    2013-04-23
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147
    Expired
    Bicalutamide (IH)
    2019-07-05
    Application Number
    24690
    225MF10084
    Indian CDSCO WC-0147
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    BICALUTAMIDE USP
    Bicalutamide at Shilpa House, #12-6...
    Bicalutamide (IH)
    Issue/Submission Date
    2011-05-11
    2013-04-23
    2019-07-05
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    Fingolimod Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    28162
    Active
    FINGOLIMOD HYDROCHLORIDE
    2014-05-30
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-145 - Rev 01
    Valid
    Fingolimod hydrochloride
    2022-07-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147
    Expired
    Fingolimod Hydrochloride IH
    2019-07-05
    Application Number
    28162
    R0-CEP 2019-145 - Rev 01
    Indian CDSCO WC-0147
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    FINGOLIMOD HYDROCHLORIDE
    Fingolimod hydrochloride
    Fingolimod Hydrochloride IH
    Issue/Submission Date
    2014-05-30
    2022-07-21
    2019-07-05
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    Imatinib Mesylate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    27927
    Active
    IMATINIB MESYLATE
    2014-03-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-121 - Rev 01
    Valid
    Imatinib mesilate
    2022-07-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147
    Expired
    Imatinib Mesylate(IH))
    2019-07-05
    Application Number
    27927
    R1-CEP 2016-121 - Rev 01
    Indian CDSCO WC-0147
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    IMATINIB MESYLATE
    Imatinib mesilate
    Imatinib Mesylate(IH))
    Issue/Submission Date
    2014-03-28
    2022-07-20
    2019-07-05
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