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    01 2Alendronate Sodium

    02 2Allopurinol

    03 2Amlodipine Besylate

    04 1Amodiaquine Hydrochloride

    05 1Amylmetacresol

    06 1Arteether

    07 1Artemether

    08 1Artesunate

    09 11Atenolol

    10 1Atovaquone

    11 1Balsalazide Disodium

    12 1Bendroflumethiazide

    13 1Benzarone

    14 1Benzbromarone

    15 2Benzocaine

    16 2Bisoprolol Fumarate

    17 1Bupropion Hydrochloride

    18 2CAS 103639-04-9

    19 2Carvedilol

    20 1Celecoxib

    21 1Cetirizine

    22 4Cetirizine Dihydrochloride

    23 1Chloroquine Phosphate

    24 7Chlorthalidone

    25 3Cilostazol

    26 1Citalopram

    27 1Citalopram Hydrobromide

    28 3Clopidogrel

    29 1Dichlorobenzyl Alcohol

    30 1Donepezil

    31 1Entacapone

    32 1Erythromycin Estolate

    33 1Escitalopram Oxalate

    34 1Estradiol

    35 1Estradiol Valerate

    36 3Etodolac

    37 5Famotidine

    38 1Felodipine

    39 1Fenofibrate

    40 20Fluconazole

    41 2Flumequine

    42 1Fluoxetine Hydrochloride

    43 2Furosemide

    44 6Glimepiride

    45 3Hydrochlorothiazide

    46 3Hydroxychloroquine Sulphate

    47 2Hydroxyzine Dihydrochloride

    48 1Hydroxyzine Pamoate

    49 1Indapamide

    50 1Isotretinoin

    51 1Lamotrigine

    52 1Levetiracetam

    53 1Levofloxacin

    54 1Lisinopril

    55 4Losartan Potassium

    56 1Lumefantrine

    57 1Meloxicam

    58 3Mesalazine

    59 2Metformin

    60 1Methylphenidate Hydrochloride

    61 1Metoclopramide

    62 2Metoclopramide Hydrochloride

    63 2Metoprolol Succinate

    64 2Metoprolol Tartrate

    65 1Midodrine

    66 1Morantel Tartrate

    67 4Nabumetone

    68 1Nandrolone Phenpropionate

    69 2Nifedipine

    70 1Norethisterone

    71 1Norethisterone Acetate

    72 1Olanzapine

    73 1Ondansetron

    74 1Ondansetron Hydrochloride

    75 1Pantoprazole Sodium

    76 4Paroxetine Hydrochloride

    77 1Pentoxifylline

    78 1Perindopril Erbumine

    79 2Phenylephrine Hydrochloride

    80 1Piperaquine Phosphate

    81 1Primaquine Diphosphate

    82 1Probenecid

    83 1Proguanil

    84 1Promethazine Hydrochloride

    85 3Propranolol Hydrochloride

    86 2Pyrantel Pamoate

    87 1Pyrantel Tartrate

    88 1Pyrimethamine

    89 2Quetiapine Hemifumarate

    90 1Ractopamine Hydrochloride

    91 2Risedronate Sodium

    92 1Risperidone

    93 1Ritalinic Acid

    94 1Serratiopeptidase

    95 1Silodosin

    96 1Simvastatin

    97 1Sulfadoxine

    98 1Sumatriptan

    99 1Telmisartan

    100 3Testosterone

    101 1Testosterone Cypionate

    102 1Testosterone Propionate

    103 1Testosterone Undecanoate

    104 1Tibolone

    105 2Torsemide

    106 2Tramadol Hydrochloride

    107 1Trazodone Hydrochloride

    108 1Triamterene

    109 1Triclabendazole

    110 1Triclosan

    111 3Trimethoprim

    112 11Valsartan

    113 1Venlafaxine Hydrochloride

    114 2Warfarin Sodium

    115 2Zaltoprofen

    116 1Zoledronic Acid

    117 1Zolpidem Tartrate

    118 1Zopiclone

    119 5Blank

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    01

    Alendronate Sodium

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

    AACR Annual meeting
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    Alendronate Sodium

    India

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

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    AACR Annual meeting
    Not Confirmed
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-11-14

    Pay. Date : 2013-07-30

    DMF Number : 21008

    Submission : 2007-12-03

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2008-090 - Rev 02

    Issue Date : 2021-04-27

    Type : Chemical

    Substance Number : 1564

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 219MF10310

    Registrant's Address : 48, Kandivli Industrial Estate, Kandivli (West), Mumbai 400 067, India

    Initial Date of Registration : 2007-10-05

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0091

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 57451-1157

    Start Marketing Date : 2013-08-16

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    02

    Furosemide

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

    AACR Annual meeting
    Not Confirmed
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    Furosemide

    India

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

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    AACR Annual meeting
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-07-23

    Pay. Date : 2013-07-15

    DMF Number : 10109

    Submission : 1993-02-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1998-020 - Rev 07

    Issue Date : 2019-10-30

    Type : Chemical

    Substance Number : 391

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 225MF10191

    Registrant's Address : 48, Kandivli Industrial Estate, Kandivli (W), Mumbai 400 067, India

    Initial Date of Registration : 2013-10-09

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0091

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 57451-0006

    Start Marketing Date : 2012-02-28

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    03

    Glimepiride

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

    AACR Annual meeting
    Not Confirmed
    arrow

    Glimepiride

    India

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

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    AACR Annual meeting
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-02-20

    Pay. Date : 2013-11-06

    DMF Number : 20037

    Submission : 2006-12-19

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-036 - Rev 01

    Issue Date : 2019-12-18

    Type : Chemical

    Substance Number : 2223

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 226MF10075

    Registrant's Address : 48, Kandivli Industrial Estate, Kandivli (W), Mumbai 400 067, India

    Initial Date of Registration : 2014-04-02

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0091

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 57451-1151

    Start Marketing Date : 2012-02-15

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : Sungwoo Chemical Co., Ltd.

    Registration Date : 2013-10-20

    Registration Number : 20080627-78-D-31-14(5)

    Manufacturer Name : IPCA Laboratories Limited

    Manufacturer Address : PO Sejavta, District-Ratlam (MP) 457001, India

     VMF Others AUDIT
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    04

    Hydrochlorothiazide

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

    AACR Annual meeting
    Not Confirmed
    arrow

    Hydrochlorothiazide

    India

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

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    AACR Annual meeting
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-11

    Pay. Date : 2012-12-05

    DMF Number : 16707

    Submission : 2003-07-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2012-044 - Rev 02

    Issue Date : 2023-09-26

    Type : Chemical

    Substance Number : 394

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 224MF10171

    Registrant's Address : 48, Kandivli Industrial Estate, Kandivli (W), Mumbai 400 067, India

    Initial Date of Registration : 2012-08-16

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0091

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 57451-1142

    Start Marketing Date : 2023-12-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : Aging Life Science Co., Ltd.

    Registration Date : 2021-03-10

    Registration Number : 20210310-209-J-862

    Manufacturer Name : IPCA Laboratories Limited

    Manufacturer Address : Sejavta Dist. Ratlam(MP)PIN. 457 002 India

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    05

    Metoprolol Tartrate

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

    AACR Annual meeting
    Not Confirmed
    arrow

    Metoprolol Tartrate

    India

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

    arrow
    AACR Annual meeting
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15850

    Submission : 2002-02-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2003-091 - Rev 04

    Issue Date : 2023-03-16

    Type : Chemical

    Substance Number : 1028

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 221MF10151

    Registrant's Address : 48, Kandivli Industrial Estate, Kandivli (W), Mumbai 400 067, INDIA

    Initial Date of Registration : 2009-07-09

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0091

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 57451-1163

    Start Marketing Date : 2019-11-08

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    06

    Propranolol Hydrochloride

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

    AACR Annual meeting
    Not Confirmed
    arrow

    Propranolol Hydrochloride

    India

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

    arrow
    AACR Annual meeting
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-07-31

    Pay. Date : 2013-07-23

    DMF Number : 15849

    Submission : 2002-02-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2002-026 - Rev 06

    Issue Date : 2023-12-06

    Type : Chemical

    Substance Number : 568

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10174

    Registrant's Address : 48, Kandivli Industrial Estate, Kandivli (W), Mumbai 400 067, India

    Initial Date of Registration : 2006-02-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0091

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 57451-1216

    Start Marketing Date : 2021-06-17

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    07

    Atenolol

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

    AACR Annual meeting
    Not Confirmed
    arrow

    Atenolol

    India

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

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    AACR Annual meeting
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    USDMF Inactive-api
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 7821

    Submission : 1988-12-15

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 1998-024 - Rev 06

    Issue Date : 2023-11-10

    Type : Chemical

    Substance Number : 703

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10439

    Registrant's Address : 48, Kandivli Industrial Estate, Kandivli (W), Mumbai 400 067, India

    Initial Date of Registration : 2006-04-27

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0091

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 57451-1115

    Start Marketing Date : 2012-02-22

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Shinil Pharmaceutical Co., Ltd.

    Registration Date : 2012-10-11

    Registration Number : 20050831-34-B-91-04(12)

    Manufacturer Name : Ipca Laboratories Limited.

    Manufacturer Address : PO Sejavta Dist. Ratlam(MP)PIN. 457 002, India

     VMF Others AUDIT
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    08

    Losartan Potassium

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

    AACR Annual meeting
    Not Confirmed
    arrow

    Losartan Potassium

    India

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

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    AACR Annual meeting
    Not Confirmed
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    USDMF Inactive-api
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16526

    Submission : 2003-04-05

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2009-190 - Rev 05

    Issue Date : 2022-08-04

    Type : Chemical

    Substance Number : 2232

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10266

    Registrant's Address : 48, Kandivli Industrial Estate, Kandivli (W), Mumbai 400 067, India

    Initial Date of Registration : 2010-12-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0091

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 57451-1211

    Start Marketing Date : 2024-12-27

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Ildong Pharmaceutical Co., Ltd.

    Registration Date : 2020-06-29

    Registration Number : 20100226-122-G-47-16(6)

    Manufacturer Name : IPCA Laboratories Limited@Ipca Laboratories Limited@[Manufacturer of intermediate (Losartan base)] Ipca Laboratories Limited, Mahad

    Manufacturer Address : PO Sejavta, District-Ratlam (MP) 457001, India@Block No. 123, 131 & 132, Village-Ranu, Tal-Padra, City : Ranu, Dist : Vadodara, Gujarat state, India@[Manufacturer of intermediate (Losartan base)] C-89 to C-95, MIDC Industrial Area, Mahad Dist. Raigad (MS)-402309 (Maharashtra), India

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    09

    Allopurinol

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

    AACR Annual meeting
    Not Confirmed
    arrow

    Allopurinol

    India

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

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    AACR Annual meeting
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-06-19

    Pay. Date : 2013-06-06

    DMF Number : 21676

    Submission : 2008-07-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2008-211 - Rev 04

    Issue Date : 2023-01-27

    Type : Chemical

    Substance Number : 576

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0091

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 57451-1166

    Start Marketing Date : 2012-02-13

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    10

    Amlodipine Besylate

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

    AACR Annual meeting
    Not Confirmed
    arrow

    Amlodipine Besylate

    India

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

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    AACR Annual meeting
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-11-12

    Pay. Date : 2013-07-23

    DMF Number : 23589

    Submission : 2010-07-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2023-139 - Rev 00

    Issue Date : 2023-07-27

    Type : Chemical

    Substance Number : 1491

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0091

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 57451-1188

    Start Marketing Date : 2019-11-06

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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