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    01 16-Aminopenicillanic Acid

    02 1Abemaciclib

    03 1Acalabrutinib

    04 1Adapalene

    05 2Afatinib

    06 2Agomelatine

    07 1Alendronate Sodium

    08 1Alogliptin Benzoate

    09 1Amantadine Hydrochloride

    10 1Apalutamide

    11 1Apixaban

    12 2Apremilast

    13 1Aripiprazole

    14 1Asenapine Maleate

    15 1Axitinib

    16 1Azilsartan

    17 3Azithromycin

    18 2Azithromycin Dihydrate

    19 1Bazedoxifene Acetate

    20 1Binimetinib

    21 1Bosentan Hydrate

    22 1Bosutinib

    23 1Bosutinib Monohydrate

    24 2Brexpiprazole

    25 1Bupropion Hydrochloride

    26 1CAS 284461-73-0

    27 1Cabozantinib

    28 1Calcium Gluconate

    29 1Canagliflozin

    30 2Candesartan Cilexetil

    31 2Celecoxib

    32 1Chlordiazepoxide

    33 1Chlordiazepoxide HCl

    34 1Choline Fenofibrate

    35 1Cilostazol

    36 2Clarithromycin

    37 1Clofarabine

    38 2Clonidine

    39 1Clopidogrel

    40 1Dabigatran Etexilate Mesylate

    41 1Dabrafenib Mesylate

    42 1Dapagliflozin

    43 1Darifenacin Hydrobromide

    44 1Darolutamide

    45 2Dasatinib

    46 4Deferasirox

    47 3Desvenlafaxine Succinate

    48 1Dexlansoprazole

    49 3Donepezil

    50 2Dronedarone Hydrochloride

    51 2Duloxetine Hydrochloride

    52 2Elvitegravir

    53 1Empagliflozin

    54 1Enzalutamide

    55 2Erlotinib Hydrochloride

    56 1Erythromycin

    57 1Erythromycin Ethyl Succinate

    58 4Etoricoxib

    59 1Etrasimod Arginine

    60 1Famotidine

    61 1Febuxostat

    62 1Felodipine

    63 3Fenofibrate

    64 1Fesoterodine

    65 2Fingolimod Hydrochloride

    66 1Fluoxetine Hydrochloride

    67 3Fluphenazine

    68 1Fluphenazine Decanoate

    69 2Gefitinib

    70 1Glatiramer Acetate

    71 1Glucagon Hydrochloride

    72 1Hydrochlorothiazide

    73 2Ibrutinib

    74 1Icatibant Acetate

    75 1Iloperidone

    76 2Irbesartan

    77 1Iron Sucrose

    78 1Ivabradine Hydrochloride

    79 1Ivacaftor

    80 1Ivosidenib

    81 1Ketorolac Trometamol

    82 4Lacosamide

    83 1Lamotrigine

    84 1Larotrectinib Sulfate

    85 1Leflunomide

    86 2Lenalidomide

    87 1Lenvatinib Mesylate

    88 1Lercanidipine HCl

    89 1Letermovir

    90 1Leuprolide Acetate

    91 1Levetiracetam

    92 1Linagliptin

    93 3Linezolid

    94 1Losartan Potassium

    95 1Lotilaner

    96 1Lovastatin

    97 1Lurasidone Hydrochloride

    98 1Macitentan

    99 1Memantine Hydrochloride

    100 1Meprobamate

    101 1Methotrexate

    102 1Metoprolol Succinate

    103 1Metoprolol Tartrate

    104 3Mexiletine

    105 1Minodronic Acid

    106 2Modafinil

    107 1Momelotinib

    108 1Nelarabine

    109 1Nisoldipine

    110 2Nitrofurantoin

    111 2Obeticholic Acid

    112 1Octreotide Acetate

    113 1Olaparib

    114 2Olmesartan Medoxomil

    115 2Osimertinib Mesylate

    116 1Oxiconazole Nitrate

    117 2Palbociclib

    118 1Penciclovir

    119 1Pentosan Polysulfate Sodium

    120 1Pinaverium Bromide

    121 3Pirfenidone

    122 1Plerixafor

    123 1Ponatinib

    124 3Pramipexole Dihydrochloride

    125 1Prasugrel

    126 2Prasugrel Hydrochloride

    127 2Pregabalin

    128 1Prucalopride Succinate

    129 1Quetiapine Hemifumarate

    130 1Rabeprazole

    131 2Ribociclib

    132 1Rifaximin

    133 1Riociguat

    134 2Rivaroxaban

    135 1Rivastigmine

    136 1Rivastigmine Tartrate

    137 2Ropinirole Hydrochloride

    138 1Roxithromycin

    139 1Ruxolitinib Phosphate

    140 2Sacubitril-Valsartan

    141 1Salcaprozate Sodium

    142 2Selexipag

    143 1Semaglutide

    144 1Silodosin

    145 2Sofosbuvir

    146 1Solifenacin Succinate

    147 2Sorafenib

    148 1Suvorexant

    149 1Tadalafil

    150 1Tegaserod

    151 3Telmisartan

    152 1Temazepam

    153 1Tenofovir

    154 1Tenofovir Alafenamide

    155 1Tenofovir Alafenamide Fumarate

    156 2Teriflunomide

    157 1Teriparatide

    158 3Theophylline

    159 2Ticagrelor

    160 1Tipiracil Hydrochloride

    161 1Tirzepatide

    162 2Topiramate

    163 1Trametinib

    164 3Valsartan

    165 1Vardenafil Hydrochloride

    166 1Venetoclax

    167 3Venlafaxine Hydrochloride

    168 2Vilazodone Hydrochloride

    169 3Vildagliptin

    170 1Viloxazine Hydrochloride

    171 1Vismodegib

    172 1Vonoprazan Fumarate

    173 1Vortioxetine Hydrobromide

    174 2Warfarin Sodium

    175 2Zolmitriptan

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    01

    Fenofibrate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    euroPLX 86 Munich
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    Fenofibrate

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    euroPLX 86 Munich
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-11

    Pay. Date : 2012-12-05

    DMF Number : 16208

    Submission : 2002-10-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2001-219 - Rev 06

    Issue Date : 2019-02-07

    Type : Chemical

    Substance Number : 1322

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10151

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2016-08-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-17

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0082

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Sungwoo Chemical Co., Ltd.

    Registration Date : 2024-09-05

    Registration Number : 20240116-209-J-1595(1)

    Manufacturer Name : Alembic Pharmaceuticals Limited (API Unit-1)

    Manufacturer Address : AT-Panelav, Tal-Halol, City: Panelav, Dist: Panchmahal, Gujarat State, 389 350, India

     VMF Others AUDIT
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    02

    Olmesartan Medoxomil

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    euroPLX 86 Munich
    Not Confirmed
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    Olmesartan Medoxomil

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    euroPLX 86 Munich
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-10-07

    Pay. Date : 2013-09-26

    DMF Number : 24671

    Submission : 2011-02-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2013-297 - Rev 01

    Issue Date : 2023-05-12

    Type : Chemical

    Substance Number : 2600

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 227MF10284

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2015-12-15

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-03

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0083

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Sungwoo Chemical Co., Ltd.

    Registration Date : 2014-03-18

    Registration Number : Su4579-2-ND

    Manufacturer Name : Alembic Pharmaceuticals Limited@[Manufacturer of starting material (Trityl Olmesartan Medoxomil)] Zhejiang Huahai Pharmaceutical Co., Ltd.

    Manufacturer Address : AT-Panelav, Tal-Halol, City : Panelav, Dist : Panchmahal, India.@Chuannan, Duqiao, Linhai, Zhejiang, China

     VMF Others AUDIT
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    03

    Ropinirole Hydrochloride

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    euroPLX 86 Munich
    Not Confirmed
    arrow

    Ropinirole Hydrochloride

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    euroPLX 86 Munich
    Not Confirmed
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19780

    Submission : 2006-09-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2022-227 - Rev 00

    Issue Date : 2023-08-09

    Type : Chemical

    Substance Number : 2604

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10173

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2016-08-29

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-17

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0082

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2023-10-25

    Registration Number : 20190104-209-J-175(1)

    Manufacturer Name : Alembic Pharmaceuticals Limited (API Unit-I).

    Manufacturer Address : AT-Panelav, Tal-Halol, City : Panelav, Dist : Panchmahal, Gujarat State, India

     VMF Others AUDIT
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    04

    Telmisartan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    euroPLX 86 Munich
    Not Confirmed
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    Telmisartan

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    euroPLX 86 Munich
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-08

    Pay. Date : 2012-12-21

    DMF Number : 20285

    Submission : 2007-02-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2008-217 - Rev 07

    Issue Date : 2022-05-16

    Type : Chemical

    Substance Number : 2154

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 231MF10053

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2019-02-21

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-17

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0082

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Leaders Bio Co., Ltd.

    Registration Date : 2019-05-15

    Registration Number : 20180814-209-J-191(3)

    Manufacturer Name : Alembic Pharmaceuticals Limited (API Unit-1)

    Manufacturer Address : AT-Panelav, Tal-Halol, City : Panelav, Dist : Panchmahal, Gujarat State, India

     VMF Others AUDIT
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    05

    Vardenafil Hydrochloride

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    euroPLX 86 Munich
    Not Confirmed
    arrow

    Vardenafil Hydrochloride

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    euroPLX 86 Munich
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-02-20

    Pay. Date : 2014-12-24

    DMF Number : 28900

    Submission : 2014-12-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-095 - Rev 01

    Issue Date : 2023-06-26

    Type : Chemical

    Substance Number : 2782

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 301MF10002

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2019-05-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-17

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0082

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : M-Peak Korea Co., Ltd.

    Registration Date : 2018-02-22

    Registration Number : 20180222-211-J-181

    Manufacturer Name : Alembic Pharmaceuticals Limited (API Unit-III)

    Manufacturer Address : Plot No. 842-843, Taluka-Padra, City : Karakhadi - 391 450, District-Vadodara Gujarat State, India

     VMF Others AUDIT
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    06

    Lamotrigine

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    euroPLX 86 Munich
    Not Confirmed
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    Lamotrigine

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    euroPLX 86 Munich
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-03-15

    Pay. Date : 2013-02-26

    DMF Number : 18732

    Submission : 2005-09-09

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2011-010 - Rev 04

    Issue Date : 2024-07-12

    Type : Chemical

    Substance Number : 1756

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10012

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2017-01-23

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-05

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0081

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    07

    Venlafaxine Hydrochloride

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    euroPLX 86 Munich
    Not Confirmed
    arrow

    Venlafaxine Hydrochloride

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    euroPLX 86 Munich
    Not Confirmed
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16551

    Submission : 2003-04-29

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2006-225 - Rev 05

    Issue Date : 2024-01-29

    Type : Chemical

    Substance Number : 2119

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 304MF10131

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2022-09-21

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-17

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0082

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    08

    Aripiprazole

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    euroPLX 86 Munich
    Not Confirmed
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    Aripiprazole

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    euroPLX 86 Munich
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-08-28

    Pay. Date : 2013-08-19

    DMF Number : 23300

    Submission : 2009-11-18

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2013-292 - Rev 02

    Issue Date : 2024-08-27

    Type : Chemical

    Substance Number : 2617

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-17

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0082

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 46708-837

    Start Marketing Date : 2015-05-22

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2022-12-22

    Registration Number : 20221222-209-J-1427

    Manufacturer Name : Alembic Pharmaceuticals Limited

    Manufacturer Address : API Division Karakhadi, Plot No. 842-843 Tal-Padra, City : Karakhadi-391 450, Dist : Vadodara, Gujarat State, India

     VMF Others AUDIT
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    09

    Bosutinib

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    euroPLX 86 Munich
    Not Confirmed
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    Bosutinib

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    euroPLX 86 Munich
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-09-02

    Pay. Date : 2016-06-10

    DMF Number : 30552

    Submission : 2016-06-30

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 306MF10032

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2024-02-21

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-17

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0082

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    10

    Celecoxib

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    euroPLX 86 Munich
    Not Confirmed
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    Celecoxib

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    euroPLX 86 Munich
    Not Confirmed
    • fda
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 24419

    Submission : 2010-11-30

    Status : Active

    Type : II

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    ✖

    Certificate Number : R1-CEP 2012-388 - Rev 03

    Issue Date : 2022-03-29

    Type : Chemical

    Substance Number : 2591

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-03

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0083

    Address of the Firm :

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