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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Smilax Laboratories Limited

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    Smilax Laboratories Limited

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    01 Atomoxetin Hydrochloride (1)

    02 Atorvastatin (1)

    03 Azilsartan (1)

    04 Blonanserin (1)

    05 Candesartan Cilexetil (1)

    06 Celecoxib (1)

    07 Citalopram Hydrobromide (1)

    08 Cloperastine (1)

    09 Dabigatran Etexilate Mesylate (1)

    10 Duloxetine (1)

    11 Escitalopram Oxalate (1)

    12 Esomeprazole Magnesium (1)

    13 Esomeprazole Sodium (1)

    14 Fexofenadine Hydrochloride (1)

    15 Gabapentin (1)

    16 Guaifenesin (1)

    17 Irbesartan (1)

    18 Itraconazole (1)

    19 Ketorolac Trometamol (1)

    20 Lamotrigine (1)

    21 Lansoprazole (1)

    22 Levocetirizine Dihydrochloride (1)

    23 Losartan Potassium (1)

    24 Meloxicam (1)

    25 Memantine Hydrochloride (1)

    26 Methocarbamol (1)

    27 Montelukast Sodium (1)

    28 Norfloxacin (1)

    29 Olanzapine (1)

    30 Olmesartan Medoxomil (1)

    31 Omeprazole (1)

    32 Omeprazole Magnesium (1)

    33 Omeprazole Sodium (1)

    34 Ondansetron (1)

    35 Pantoprazole Sodium (1)

    36 Pioglitazone (1)

    37 Pregabalin (1)

    38 Ranolazine (1)

    39 Repaglinide (1)

    40 Risperidone (1)

    41 Rosuvastatin Calcium (1)

    42 Sertraline Hydrochloride (1)

    43 Sildenafil Citrate (1)

    44 Silodosin (1)

    45 Sumatriptan (1)

    46 Tadalafil (1)

    47 Tamsulosin (1)

    48 Telmisartan (1)

    49 Terbinafine Hydrochloride (1)

    50 Valsartan (1)

    51 Vardenafil Hydrochloride (1)

    52 Blank (1)

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    01 Inactive (1)

    02 Blank (51)

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    01 Valid (2)

    02 Withdrawn by Holder (1)

    03 Blank (49)

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    01 302MF10097 (1)

    02 305MF10046 (1)

    03 Blank (50)

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    01 WC-0068 (3)

    02 WC-0176 (2)

    03 Blank (47)

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    Omeprazole

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2009-052 - Rev 00
    Valid
    Omeprazole
    2015-09-28
    Japanese DMF

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    Written Confirmation

    Caution WC

    Indian CDSCO WC-0176
    Expired
    Omeprazole (Ph. Eur)
    2020-08-25
    Application Number
    R1-CEP 2009-052 - Rev 00
    Indian CDSCO WC-0176
    Status
    Valid
     
    Expired
    2023-05-12
    Filing Details
    Omeprazole
    Omeprazole (Ph. Eur)
    Issue/Submission Date
    2015-09-28
    2020-08-25
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    Pantoprazole Sodium

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    USDMF

    Caution USDMF

    25583
    Inactive
    PANTOPRAZOLE SODIUM
    2011-10-21
    CEP/COS

    Caution CEP/COS

    R0-CEP 2012-098 - Rev 01
    Withdrawn by Holder
    Pantoprazole sodium sesquihydrate
    2015-09-21
    Japanese DMF

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    Written Confirmation

    Caution WC

    Indian CDSCO WC-0068
    Expired
    Pantoprazole Sodium sesquihydrate (...
    2020-05-06
    Application Number
    25583
    R0-CEP 2012-098 - Rev 01
    Indian CDSCO WC-0068
    Status
    Inactive
    Fees Unpaid
    N/A
    Withdrawn by Holder
     
    Expired
    2022-07-02
    Filing Details
    PANTOPRAZOLE SODIUM
    Pantoprazole sodium sesquihydrate
    Pantoprazole Sodium sesquihydrate (...
    Issue/Submission Date
    2011-10-21
    2015-09-21
    2020-05-06
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    Candesartan Cilexetil

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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 2022-171 - Rev 00
    Valid
    Candesartan cilexetil
    2024-03-06
    Japanese DMF

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    Written Confirmation

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    Application Number
    CEP 2022-171 - Rev 00
    Status
    Valid
     
    Filing Details
    Candesartan cilexetil
    Issue/Submission Date
    2024-03-06
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    Cloperastine

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    USDMF

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    CEP/COS

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    Japanese DMF

    Found JDMF

    305MF10046
    Cloperastine Hydrochloride at Plot ...
    2023-04-05
    Written Confirmation

    Close WC

    Application Number
    305MF10046
    Status
     
    Filing Details
    Cloperastine Hydrochloride at Plot ...
    Issue/Submission Date
    2023-04-05
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    SLX-193

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    302MF10097
    SLX-193 at Plot No. 12/A, Phase III...
    2020-08-05
    Written Confirmation

    Close WC

    Application Number
    302MF10097
    Status
     
    Filing Details
    SLX-193 at Plot No. 12/A, Phase III...
    Issue/Submission Date
    2020-08-05
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    Lansoprazole

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0068
    Expired
    Lansoprazole (USP/Ph. Eur.)
    2020-05-06
    Application Number
    Indian CDSCO WC-0068
    Status
     
    Expired
    2022-07-02
    Filing Details
    Lansoprazole (USP/Ph. Eur.)
    Issue/Submission Date
    2020-05-06
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    Norfloxacin

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0068
    Expired
    Norfloxacin (Ph. Eur.)
    2020-05-06
    Application Number
    Indian CDSCO WC-0068
    Status
     
    Expired
    2022-07-02
    Filing Details
    Norfloxacin (Ph. Eur.)
    Issue/Submission Date
    2020-05-06
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    Repaglinide

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0176
    Expired
    Repaglinide (Ph. Eur)
    2020-08-25
    Application Number
    Indian CDSCO WC-0176
    Status
     
    Expired
    2023-05-12
    Filing Details
    Repaglinide (Ph. Eur)
    Issue/Submission Date
    2020-08-25
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    Atomoxetin Hydrochloride

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    Atorvastatin

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Status
     
    Filing Details
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