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    List of Active Pharmaceutical Ingredients (APIs) for which Written Confirmation(s) have been obtained by Alkem Laboratories Ltd

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    01 Amlodipine Besilate USP (1)

    02 Amlodipine Besylate (USP) (1)

    03 Aripiprazole  (USP/EP) (1)

    04 Benzoyl Peroxide Hydrous USP (1)

    05 Dalfampridine IH (1)

    06 Duloxetine Hydrochlorde USP (1)

    07 Duloxetine Hydrochloride USP (1)

    08 Lansoprazole (USP) (1)

    09 Lansoprazole USP (1)

    10 Paliperidone (IH) (1)

    11 Paliperidone IH (1)

    12 Rasagiline Mesylate (IH) (1)

    13 Rasagiline Mesylate IH (1)

    14 Riluzole USP (2)

    15 Rizatriptan Benzoate USP (2)

    16 Sodium Oxybate IH (1)

    17 Tapentadol Hydrochloride IH (1)

    18 Tapentadole Hydrochloride (IH) (1)

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    01 M/s Alkem Laboratories (8)

    02 M/s Alkem Laboratories Limited (2)

    03 M/s Alkem Laboratories Ltd (10)

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    01 WC-0370 (10)

    02 WC-0370A3 (2)

    03 WC-037a1 (6)

    04 WC-0385 (2)

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    01 India (20)

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    Amlodipine Besylate (USP)

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    M/s Alkem Laboratories Ltd
    WC-0370
    2025-06-05
    2022-09-30
    Plot No. 289-290 G.I.D.C Ankleshwar, Bharuch, Gujarat.
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    Amlodipine Besilate USP

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    M/s Alkem Laboratories
    WC-037a1
    2022-06-05
    2019-11-18
    Plot No. 289-290 G.I.D.C Ankleshwar, Bharuch, Gujarat.
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    Aripiprazole  (USP/EP)

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    M/s Alkem Laboratories Limited
    WC-0385
    2022-09-05
    2020-03-13
    Survey No. 85 to 88 89 Naugama, N.H No-8 At & Post Mandav al-Ankleshwar
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    Benzoyl Peroxide Hydrous USP

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    M/s Alkem Laboratories Limited
    WC-0385
    2022-09-05
    2020-03-13
    Survey No. 85 to 88 89 Naugama, N.H No-8 At & Post Mandav al-Ankleshwar
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    Duloxetine Hydrochlorde USP

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    M/s Alkem Laboratories Ltd
    WC-0370
    2025-06-05
    2022-09-30
    Plot No. 289-290 G.I.D.C Ankleshwar, Bharuch, Gujarat.
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    Duloxetine Hydrochloride USP

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    M/s Alkem Laboratories
    WC-037a1
    2022-06-05
    2019-11-18
    Plot No. 289-290 G.I.D.C Ankleshwar, Bharuch, Gujarat.
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    Dalfampridine IH

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    M/s Alkem Laboratories Ltd
    WC-0370
    2025-06-05
    2022-09-30
    Plot No. 289-290 G.I.D.C Ankleshwar, Bharuch, Gujarat.
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    Lansoprazole (USP)

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    M/s Alkem Laboratories Ltd
    WC-0370
    2025-06-05
    2022-09-30
    Plot No. 289-290 G.I.D.C Ankleshwar, Bharuch, Gujarat.
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    Lansoprazole USP

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    M/s Alkem Laboratories
    WC-037a1
    2022-06-05
    2019-11-18
    Plot No. 289-290 G.I.D.C Ankleshwar, Bharuch, Gujarat.
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    Paliperidone (IH)

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    M/s Alkem Laboratories Ltd
    WC-0370
    2025-06-05
    2022-09-30
    Plot No. 289-290 G.I.D.C Ankleshwar, Bharuch, Gujarat.
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