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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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    India
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    Unit-I Plot no: 12/A, Phase - III, IDA, Jeedimetla, Hyderabad-500 055, Telangana
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    +91 402 309 0260
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    Omeprazole

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    CEP/COS

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

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    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    Withdrawn by Holder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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    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    Withdrawn by Holder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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    CEP/COS

    Found CEP/COS

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

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    Found JDMF

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

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

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    CEP/COS

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    Found JDMF

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

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    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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    CEP/COS

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    Japanese DMF

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    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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    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

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    CEP/COS

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    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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    Atorvastatin

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    Azilsartan

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    Blonanserin

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    Celecoxib

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    USDMF

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    Citalopram Hydrobromide

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    Dabigatran Etexilate Mesylate

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    Duloxetine

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    USDMF

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    CEP/COS

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    Escitalopram Oxalate

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    Esomeprazole Magnesium

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    Esomeprazole Sodium

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    Fexofenadine Hydrochloride

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    Gabapentin

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    Guaifenesin

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    Irbesartan

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    Itraconazole

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    Ketorolac Trometamol

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    Lamotrigine

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    Levocetirizine Dihydrochloride

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    Losartan Potassium

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    Meloxicam

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    Memantine Hydrochloride

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    Methocarbamol

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    Montelukast Sodium

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    Olanzapine

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    Olmesartan Medoxomil

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    Omeprazole Magnesium

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    Omeprazole Sodium

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    Ondansetron

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