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    01 2Alendronate Sodium

    02 2Allopurinol

    03 2Amlodipine Besylate

    04 1Amodiaquine Hydrochloride

    05 1Amylmetacresol

    06 1Arteether

    07 1Artemether

    08 1Artesunate

    09 2Atenolol

    10 1Atovaquone

    11 1Balsalazide Disodium

    12 1Bendroflumethiazide

    13 1Benzarone

    14 1Benzbromarone

    15 2Bisoprolol Fumarate

    16 1Bupropion Hydrochloride

    17 1Carvedilol

    18 1Celecoxib

    19 1Cetirizine

    20 2Cetirizine Dihydrochloride

    21 1Chloroquine Phosphate

    22 2Chlorthalidone

    23 1Cilostazol

    24 1Citalopram

    25 1Citalopram Hydrobromide

    26 3Clopidogrel

    27 1Dichlorobenzyl Alcohol

    28 1Donepezil

    29 1Entacapone

    30 1Erythromycin Estolate

    31 1Escitalopram Oxalate

    32 1Estradiol

    33 1Estradiol Valerate

    34 3Etodolac

    35 2Famotidine

    36 1Fenofibrate

    37 2Fluconazole

    38 2Flumequine

    39 2Furosemide

    40 1Glimepiride

    41 3Hydrochlorothiazide

    42 1Hydroxychloroquine Sulphate

    43 1Hydroxyzine Dihydrochloride

    44 1Indapamide

    45 1Isotretinoin

    46 1Lamotrigine

    47 1Levetiracetam

    48 1Levofloxacin

    49 1Lisinopril

    50 3Losartan Potassium

    51 1Lumefantrine

    52 1Meloxicam

    53 3Mesalazine

    54 2Metformin

    55 1Methylphenidate Hydrochloride

    56 1Metoclopramide

    57 1Metoclopramide Hydrochloride

    58 2Metoprolol Succinate

    59 2Metoprolol Tartrate

    60 1Midodrine

    61 1Morantel Tartrate

    62 2Nabumetone

    63 1Nandrolone Phenpropionate

    64 2Nifedipine

    65 1Norethisterone

    66 1Norethisterone Acetate

    67 1Olanzapine

    68 1Ondansetron

    69 1Ondansetron Hydrochloride

    70 1Pantoprazole Sodium

    71 1Paroxetine Hydrochloride

    72 1Pentoxifylline

    73 1Perindopril Erbumine

    74 2Phenylephrine Hydrochloride

    75 1Piperaquine Phosphate

    76 1Primaquine Diphosphate

    77 1Probenecid

    78 1Proguanil

    79 1Promethazine Hydrochloride

    80 1Propranolol Hydrochloride

    81 2Pyrantel Pamoate

    82 1Pyrantel Tartrate

    83 1Pyrimethamine

    84 2Quetiapine Hemifumarate

    85 1Ractopamine Hydrochloride

    86 2Risedronate Sodium

    87 1Risperidone

    88 1Ritalinic Acid

    89 1Serratiopeptidase

    90 1Silodosin

    91 1Simvastatin

    92 1Sulfadoxine

    93 1Sumatriptan

    94 1Telmisartan

    95 3Testosterone

    96 1Testosterone Cypionate

    97 1Testosterone Decanoate

    98 1Testosterone Isocaproate

    99 1Testosterone Phenylpropionate

    100 1Testosterone Propionate

    101 1Testosterone Undecanoate

    102 1Tibolone

    103 1Torsemide

    104 2Tramadol Hydrochloride

    105 1Trazodone Hydrochloride

    106 1Triamterene

    107 1Triclabendazole

    108 1Triclosan

    109 2Trimethoprim

    110 2Valsartan

    111 1Venlafaxine Hydrochloride

    112 2Warfarin Sodium

    113 2Zaltoprofen

    114 1Zoledronic Acid

    115 1Zolpidem Tartrate

    116 1Zopiclone

    117 4Blank

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    01

    Alendronate Sodium

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

    Pharmtech & Ingredients
    Not Confirmed
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    Alendronate Sodium

    India

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

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    Pharmtech & Ingredients
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    USDMF arrow-down Click Us! arrow-down
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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 : 2024-12-31

    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

    Pharmtech & Ingredients
    Not Confirmed
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    Furosemide

    India

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

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    Pharmtech & Ingredients
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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
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    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 : 2024-12-31

    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

    Pharmtech & Ingredients
    Not Confirmed
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    Glimepiride

    India

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

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    Pharmtech & Ingredients
    Not Confirmed
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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 : 2024-12-31

    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

    Pharmtech & Ingredients
    Not Confirmed
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    Hydrochlorothiazide

    India

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

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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 : 57451-1127

    Start Marketing Date : 2012-03-02

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    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

    Pharmtech & Ingredients
    Not Confirmed
    arrow

    Metoprolol Tartrate

    India

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

    arrow
    Pharmtech & Ingredients
    Not Confirmed
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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 : 2024-12-31

    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

    Pharmtech & Ingredients
    Not Confirmed
    arrow

    Propranolol Hydrochloride

    India

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

    arrow
    Pharmtech & Ingredients
    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 : 57451-1124

    Start Marketing Date : 2012-03-29

    End Marketing Date : 2024-12-31

    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

    Pharmtech & Ingredients
    Not Confirmed
    arrow

    Atenolol

    India

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

    arrow
    Pharmtech & Ingredients
    Not Confirmed
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    USDMF Inactive-api
    ✖

    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 : 2024-12-31

    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

    Pharmtech & Ingredients
    Not Confirmed
    arrow

    Losartan Potassium

    India

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

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    Pharmtech & Ingredients
    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 : R0-CEP 2019-224 - Rev 03

    Issue Date : 2023-01-12

    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 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), 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

    Pharmtech & Ingredients
    Not Confirmed
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    Allopurinol

    India

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

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    Pharmtech & Ingredients
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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 : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    10

    Amlodipine Besylate

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

    Pharmtech & Ingredients
    Not Confirmed
    arrow

    Amlodipine Besylate

    India

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

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    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 : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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