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

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    01 Alfuzosin HCl (1)

    02 Allopurinol (1)

    03 Amiodarone Hydrochloride (1)

    04 Amlodipine Besylate (2)

    05 Amlodipine Maleate (1)

    06 Apixaban (1)

    07 Apremilast (1)

    08 Aripiprazole (1)

    09 Atomoxetin Hydrochloride (1)

    10 Baclofen (1)

    11 Bendroflumethiazide (1)

    12 Bisoprolol Fumarate (1)

    13 Brexpiprazole (1)

    14 Brimonidine Tartrate (1)

    15 Bumetanide (1)

    16 Buprenorphine Hydrochloride (2)

    17 Buspirone Hydrochloride (2)

    18 Canagliflozin (1)

    19 Celecoxib (1)

    20 Cetirizine Dihydrochloride (1)

    21 Chlorthalidone (1)

    22 Cinacalcet Hydrochloride (1)

    23 Clomiphene Citrate (1)

    24 Clonidine (2)

    25 Cyclobenzaprine (1)

    26 Dabigatran Etexilate Mesylate (1)

    27 Dimethyl Fumarate (1)

    28 Diphenhydramine Hydrochloride (2)

    29 Divalproex Sodium (1)

    30 Donepezil (1)

    31 Doxazosin Mesylate (1)

    32 Eprosartan Mesylate (1)

    33 Eslicarbazepine Acetate (1)

    34 Fenofibrate (2)

    35 Fesoterodine (1)

    36 Flutamide (1)

    37 Glipizide (1)

    38 Guanfacine (1)

    39 Hydralazine Hydrochloride (1)

    40 Hydrochlorothiazide (3)

    41 Irbesartan (1)

    42 Labetalol Hydrochloride (1)

    43 Lacidipine (1)

    44 Lacosamide (1)

    45 Lamotrigine (1)

    46 Leflunomide (1)

    47 Losartan Potassium (1)

    48 Lurasidone Hydrochloride (1)

    49 Meclizine Hydrochloride (1)

    50 Meloxicam (2)

    51 Memantine Hydrochloride (1)

    52 Metoprolol Succinate (1)

    53 Metronidazole (3)

    54 Milnacipran Hydrochloride (1)

    55 Mirabegron (1)

    56 Montelukast Sodium (1)

    57 Nateglinide (2)

    58 Nifedipine (1)

    59 Olmesartan Medoxomil (1)

    60 Paliperidone (1)

    61 Phenylephrine Hydrochloride (1)

    62 Phenytoin Sodium (1)

    63 Piroxicam (1)

    64 Pramipexole Dihydrochloride (1)

    65 Prasugrel (1)

    66 Prasugrel Hydrochloride (1)

    67 Pyridostigmine (1)

    68 Quetiapine Hemifumarate (2)

    69 Ranolazine (1)

    70 Rivaroxaban (1)

    71 Rizatriptan Benzoate (1)

    72 Sacubitril Sodium (1)

    73 Solifenacin Succinate (1)

    74 Solriamfetol Hydrochloride (1)

    75 Sucralfate (1)

    76 Tadalafil (2)

    77 Tamsulosin (1)

    78 Telmisartan (1)

    79 Teriflunomide (1)

    80 Thioacetazone (1)

    81 Tiagabine Hydrochloride (1)

    82 Ticagrelor (1)

    83 Tizanidine HCl (2)

    84 Tofacitinib Citrate (1)

    85 Tolterodine Tartrate (1)

    86 Topiramate (1)

    87 Tramadol Hydrochloride (1)

    88 Vortioxetine Hydrobromide (1)

    89 Warfarin Sodium (1)

    90 Zolmitriptan (1)

    91 Zolpidem Tartrate (1)

    filter

    01 Active (76)

    02 Inactive (15)

    03 Blank (15)

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    01 Valid (27)

    02 Withdrawn by Holder (6)

    03 Blank (73)

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    01 219MF10088 (1)

    02 225MF10021 (1)

    03 231MF10060 (1)

    04 Blank (103)

    filter

    01 WC-0062 (27)

    02 WC-0062A3 (3)

    03 WC-0062A4 (1)

    04 WC-0063 (22)

    05 WC-0063A3 (1)

    06 WC-0468 (1)

    07 WC-0468A1 (1)

    08 Blank (50)

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    Amlodipine Besylate

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    USDMF

    Found USDMF

    16509
    Active
    AMLODIPINE BESILATE USP
    2003-04-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-184 - Rev 07
    Valid
    Amlodipine besilate
    2022-06-21
    Japanese DMF

    Found JDMF

    231MF10060
    Amlodipine besilate at Unichem Bhav...
    2019-02-26
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0063
    Expired
    Amlodipine Besylate (Ph. Eur.)
    2019-07-29
    Application Number
    16509
    R1-CEP 2002-184 - Rev 07
    231MF10060
    Indian CDSCO WC-0063
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-28
    Filing Details
    AMLODIPINE BESILATE USP
    Amlodipine besilate
    Amlodipine besilate at Unichem Bhav...
    Amlodipine Besylate (Ph. Eur.)
    Issue/Submission Date
    2003-04-01
    2022-06-21
    2019-02-26
    2019-07-29
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    Meloxicam

    PDF Supplier PDF
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    USDMF

    Found USDMF

    16189
    Active
    MELOXICAM USP
    2002-10-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-039 - Rev 01
    Valid
    Meloxicam
    2016-07-22
    Japanese DMF

    Found JDMF

    219MF10088
    Meloxicam at Unichem Bhavan, Prabha...
    2007-03-14
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0063
    Expired
    Meloxicam (Ph. Fur.)
    2019-07-29
    Application Number
    16189
    R1-CEP 2009-039 - Rev 01
    219MF10088
    Indian CDSCO WC-0063
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-28
    Filing Details
    MELOXICAM USP
    Meloxicam
    Meloxicam at Unichem Bhavan, Prabha...
    Meloxicam (Ph. Fur.)
    Issue/Submission Date
    2002-10-04
    2016-07-22
    2007-03-14
    2019-07-29
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    Hydrochlorothiazide

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    USDMF

    Caution USDMF

    6237
    Inactive
    HYDROCHLOROTHIAZIDE B.P.
    1985-06-10
    CEP/COS

    Found CEP/COS

    CEP 2000-091 - Rev 06
    Valid
    Hydrochlorothiazide
    2023-09-12
    Japanese DMF

    Found JDMF

    225MF10021
    Japanese Pharmacopoeia hydrochlorot...
    2013-02-06
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0468
    Expired
    Hydrochlorthiazide EP/USP
    2020-03-31
    Application Number
    6237
    CEP 2000-091 - Rev 06
    225MF10021
    Indian CDSCO WC-0468
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2023-03-30
    Filing Details
    HYDROCHLOROTHIAZIDE B.P.
    Hydrochlorothiazide
    Japanese Pharmacopoeia hydrochlorot...
    Hydrochlorthiazide EP/USP
    Issue/Submission Date
    1985-06-10
    2023-09-12
    2013-02-06
    2020-03-31
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    Alfuzosin HCl

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    USDMF

    Found USDMF

    22638
    Active
    ALFUZOSIN HYDROCHLORIDE USP
    2009-03-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-294 - Rev 00
    Valid
    Alfuzosin hydrochloride
    2015-09-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0062
    Expired
    Alfuzosin HCL (Ph. Eur.)
    2019-07-22
    Application Number
    22638
    R1-CEP 2008-294 - Rev 00
    Indian CDSCO WC-0062
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-21
    Filing Details
    ALFUZOSIN HYDROCHLORIDE USP
    Alfuzosin hydrochloride
    Alfuzosin HCL (Ph. Eur.)
    Issue/Submission Date
    2009-03-30
    2015-09-16
    2019-07-22
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    Aripiprazole

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    USDMF

    Found USDMF

    24098
    Active
    ARIPIPRAZOLE USP
    2010-09-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-010 - Rev 00
    Valid
    Aripiprazole
    2021-09-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0063
    Expired
    Aripriprazole (EP)
    2019-07-29
    Application Number
    24098
    R1-CEP 2015-010 - Rev 00
    Indian CDSCO WC-0063
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-28
    Filing Details
    ARIPIPRAZOLE USP
    Aripiprazole
    Aripriprazole (EP)
    Issue/Submission Date
    2010-09-02
    2021-09-23
    2019-07-29
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    Bendroflumethiazide

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    USDMF

    Found USDMF

    15847
    Active
    BENDROFLUMETHIAZIDE USP
    2002-02-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-102 - Rev 01
    Valid
    Bendroflumethiazide
    2009-03-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0063
    Expired
    Bendroflumethiazide (Ph. Eur.)
    2019-07-29
    Application Number
    15847
    R1-CEP 2002-102 - Rev 01
    Indian CDSCO WC-0063
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-28
    Filing Details
    BENDROFLUMETHIAZIDE USP
    Bendroflumethiazide
    Bendroflumethiazide (Ph. Eur.)
    Issue/Submission Date
    2002-02-04
    2009-03-23
    2019-07-29
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    Bisoprolol Fumarate

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    USDMF

    Found USDMF

    16398
    Active
    BISOPROLOL FUMARATE USP
    2003-01-29
    CEP/COS

    Found CEP/COS

    CEP 2008-038 - Rev 02
    Valid
    Bisoprolol fumarate
    2024-03-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0063
    Expired
    Bisoprolol Fumarate (Ph. Eur.)
    2019-07-29
    Application Number
    16398
    CEP 2008-038 - Rev 02
    Indian CDSCO WC-0063
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-28
    Filing Details
    BISOPROLOL FUMARATE USP
    Bisoprolol fumarate
    Bisoprolol Fumarate (Ph. Eur.)
    Issue/Submission Date
    2003-01-29
    2024-03-22
    2019-07-29
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    Buspirone Hydrochloride

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    USDMF

    Found USDMF

    29704
    Active
    BUSPIRONE HYDROCHLORIDE USP
    2015-09-29
    CEP/COS

    Found CEP/COS

    CEP 2022-151 - Rev 00
    Valid
    Buspirone hydrochloride
    2023-12-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0062A4
    Expired
    Buspirone Hydrochloride USP
    2021-05-21
    Application Number
    29704
    CEP 2022-151 - Rev 00
    Indian CDSCO WC-0062A4
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-21
    Filing Details
    BUSPIRONE HYDROCHLORIDE USP
    Buspirone hydrochloride
    Buspirone Hydrochloride USP
    Issue/Submission Date
    2015-09-29
    2023-12-06
    2021-05-21
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    Hydrochlorothiazide

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    USDMF

    Found USDMF

    16278
    Active
    HYDROCHLOROTHIAZIDE USP
    2002-11-26
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-017 - Rev 00
    Valid
    Hydrochlorothiazide, Process 2
    2020-04-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0063
    Expired
    Hydrochlorthiazide (Ph. Eur.)
    2019-07-29
    Application Number
    16278
    R0-CEP 2020-017 - Rev 00
    Indian CDSCO WC-0063
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-28
    Filing Details
    HYDROCHLOROTHIAZIDE USP
    Hydrochlorothiazide, Process 2
    Hydrochlorthiazide (Ph. Eur.)
    Issue/Submission Date
    2002-11-26
    2020-04-28
    2019-07-29
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    Irbesartan

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23835
    Active
    IRBESARTAN USP
    2010-06-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-151 - Rev 02
    Valid
    Irbesartan
    2022-03-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0062A3
    Expired
    Irbesartan EP
    2019-10-03
    Application Number
    23835
    R1-CEP 2011-151 - Rev 02
    Indian CDSCO WC-0062A3
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-21
    Filing Details
    IRBESARTAN USP
    Irbesartan
    Irbesartan EP
    Issue/Submission Date
    2010-06-04
    2022-03-01
    2019-10-03
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