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    01 17-Amino-3-Vinyl-3-Cephem-4-Carboxylic Acid

    02 17-Aminodesacetoxycephalosporanic Acid

    03 2Abacavir

    04 2Abacavir Sulfate

    05 1Acotiamide

    06 1Alendronate Sodium

    07 1Amlodipine Besylate

    08 2Apremilast

    09 1Armodafinil

    10 1Asenapine Maleate

    11 2Atazanavir Sulfate

    12 3Atorvastatin

    13 1Azilsartan

    14 2Azithromycin

    15 1Azithromycin Dihydrate

    16 1Bempedoic Acid

    17 2Benazepril Hydrochloride

    18 1Bicalutamide

    19 1Bictegravir Sodium

    20 1Bimatoprost

    21 1Brexpiprazole

    22 1Brimonidine Tartrate

    23 1Brivaracetam

    24 1Bupropion Hydrobromide

    25 1Bupropion Hydrochloride

    26 1Calcium

    27 2Canagliflozin

    28 1Cannabidiol

    29 1Carvedilol

    30 1Carvedilol Phosphate

    31 16Cefaclor

    32 4Cefadroxil

    33 1Cefdinir

    34 1Cefdinir Monohydrate

    35 1Cefditoren Pivoxil

    36 2Cefepime Hydrochloride

    37 1Cefixime

    38 1Cefotaxime

    39 1Cefpodoxime Proxetil

    40 1Cefprozil

    41 2Ceftiofur Sodium

    42 1Ceftriaxone

    43 3Cefuroxime Axetil

    44 1Celecoxib

    45 3Cephalexin

    46 2Cephalexin Monohydrate

    47 1Choline Fenofibrate

    48 1Cinacalcet Hydrochloride

    49 1Clindamycin Palmitate

    50 1Clopidogrel

    51 1Colesevelam Hydrochloride

    52 1Cysteamine Bitartrate

    53 1Dabigatran Etexilate Mesylate

    54 1Dapagliflozin

    55 1Dapagliflozin Propanediol Monohydrate

    56 2Darunavir

    57 2Darunavir Ethanolate

    58 1Desloratadine

    59 1Desogestrel

    60 2Desvenlafaxine Benzoate

    61 1Desvenlafaxine Succinate

    62 1Deutetrabenazine

    63 1Dexlansoprazole

    64 1Dienogest

    65 2Dolutegravir Sodium

    66 1Donepezil

    67 1Doxcercalciferol

    68 1Dronedarone Hydrochloride

    69 1Drospirenone

    70 1Droxidopa

    71 2Duloxetine Hydrochloride

    72 1Efavirenz

    73 1Efinaconazole

    74 1Elagolix Sodium

    75 1Empagliflozin

    76 1Emtricitabine

    77 1Escitalopram Oxalate

    78 1Eslicarbazepine Acetate

    79 1Esomeprazole Magnesium

    80 1Estradiol

    81 1Estradiol Valerate

    82 1Eszopiclone

    83 2Ethambutol Dihydrochloride

    84 1Ethinyl Estradiol

    85 5Ezetimibe

    86 2Febuxostat

    87 2Fenofibrate

    88 1Ferric Carboxymaltose

    89 2Ferric Citrate

    90 1Ferumoxytol

    91 1Fesoterodine

    92 1Fluticasone Furoate

    93 1Fluticasone Propionate

    94 1Fluvastatin Sodium

    95 1Fosamprenavir

    96 1Gatifloxacin

    97 1Glipizide

    98 1Glycerol Phenylbutyrate

    99 1Hydrocortisone Valerate

    100 1Idelalisib

    101 1Iloperidone

    102 1Imipramine

    103 1Imipramine Hydrochloride

    104 2Irbesartan

    105 2Iron Sucrose

    106 1Ivacaftor

    107 1Lacosamide

    108 2Lamivudine

    109 1Lamotrigine

    110 1Lansoprazole

    111 1Latanoprost

    112 1Ledipasvir

    113 1Letermovir

    114 2Levetiracetam

    115 1Levofloxacin

    116 1Levomefolate Calcium

    117 2Levonorgestrel

    118 1Levothyroxine Sodium

    119 1Linezolid

    120 2Lisinopril

    121 1Lopinavir

    122 1Lorcaserin HCl

    123 2Losartan Potassium

    124 3Lovastatin

    125 1Lurasidone Hydrochloride

    126 1Memantine Hydrochloride

    127 2Mesalazine

    128 1Metaxalone

    129 1Metformin

    130 1Methylprednisolone Sodium Succinate

    131 1Migalastat

    132 1Milnacipran Hydrochloride

    133 2Mirabegron

    134 1Nabumetone

    135 1Norethisterone

    136 1Norethisterone Acetate

    137 1Norgestimate

    138 1Olmesartan Medoxomil

    139 1Omeprazole

    140 1Omeprazole Magnesium

    141 1Oseltamivir Phosphate

    142 1Paliperidone

    143 1Pantoprazole Sodium

    144 1Perindopril Erbumine

    145 1Pioglitazone Hydrochloride

    146 1Pirfenidone

    147 1Piribedil

    148 2Pitavastatin

    149 1Potassium Warfarin

    150 1Prasugrel Hydrochloride

    151 2Pregabalin

    152 1Propranolol Hydrochloride

    153 4Pyrazinamide

    154 1Quetiapine Hemifumarate

    155 1Quinapril

    156 1Rabeprazole Sodium

    157 2Raltegravir Potassium

    158 2Ramipril

    159 1Ranolazine

    160 2Rifabutin

    161 1Rifampicin

    162 2Rifamycin

    163 1Rifapentine

    164 2Rifaximin

    165 1Risperidone

    166 3Ritonavir

    167 1Rivaroxaban

    168 1Rosuvastatin Calcium

    169 1Rufinamide

    170 1Sacubitril Sodium

    171 1Sacubitril-Valsartan

    172 1Salbutamol Sulphate

    173 1Sertraline Hydrochloride

    174 1Sevelamer Carbonate

    175 1Sevelamer Hydrochloride

    176 2Simvastatin

    177 1Sitagliptin Phosphate

    178 1Sodium Zirconium Cyclosilicate

    179 1Sofosbuvir

    180 1Telmisartan

    181 1Teneligliptin Hydrobromide

    182 2Tenofovir Alafenamide Fumarate

    183 2Tenofovir Disoproxil Fumarate

    184 1Testosterone

    185 1Tetrabenazine

    186 1Tetraferric tricitrate decahydrate

    187 1Tiotropium Bromide

    188 1Tolterodine Tartrate

    189 1Tolvaptan

    190 1Topiramate

    191 1Trandolapril

    192 1Travoprost

    193 1Umeclidinium Bromide

    194 1Valacyclovir Hydrochloride

    195 1Valbenazine Tosylate

    196 1Valsartan

    197 1Varenicline Tartrate

    198 1Venlafaxine Hydrochloride

    199 1Vilanterol Trifenatate

    200 1Vilazodone Hydrochloride

    201 1Vortioxetine Hydrobromide

    202 1Ziprasidone Hydrochloride

    203 1Zolpidem Tartrate

    204 2Blank

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    01

    Amlodipine Besylate

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

    IOPC
    Not Confirmed
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    Amlodipine Besylate

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-01-27

    Pay. Date : 2014-01-21

    DMF Number : 18839

    Submission : 2005-10-05

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2006-031 - Rev 02

    Issue Date : 2017-05-05

    Type : Chemical

    Substance Number : 1491

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10116

    Registrant's Address : Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai 400055, India

    Initial Date of Registration : 2010-03-25

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-09-10

    Written Confirmation Number : WC-0201

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    02

    Duloxetine Hydrochloride

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

    IOPC
    Not Confirmed
    arrow

    Duloxetine Hydrochloride

    India

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

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    IOPC
    Not Confirmed
    • fda
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21524

    Submission : 2008-04-08

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-144 - Rev 00

    Issue Date : 2022-03-17

    Type : Chemical

    Substance Number : 2594

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 302MF10025

    Registrant's Address : Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai 400055, India

    Initial Date of Registration : 2020-02-06

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-09-10

    Written Confirmation Number : WC-0201

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    03

    Ethambutol Dihydrochloride

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

    IOPC
    Not Confirmed
    arrow

    Ethambutol Dihydrochloride

    India

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

    arrow
    IOPC
    Not Confirmed
    • fda
    • EDQM
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20404

    Submission : 2007-03-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2000-019 - Rev 06

    Issue Date : 2021-03-18

    Type : Chemical

    Substance Number : 553

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 225MF10019

    Registrant's Address : Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai 400055, India

    Initial Date of Registration : 2013-02-05

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-09-10

    Written Confirmation Number : WC-0201

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    04

    Levetiracetam

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

    IOPC
    Not Confirmed
    arrow

    Levetiracetam

    India

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

    arrow
    IOPC
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19080

    Submission : 2005-12-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2013-242 - Rev 03

    Issue Date : 2024-03-22

    Type : Chemical

    Substance Number : 2535

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 302MF10101

    Registrant's Address : Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai 400055, India

    Initial Date of Registration : 2020-08-18

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-09-10

    Written Confirmation Number : WC-0201

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Masung LS Co., Ltd.

    Registration Date : 2017-10-24

    Registration Number : 20171024-183-I-521-28

    Manufacturer Name : Lupin Limited

    Manufacturer Address : T-142, Tarapur, Via Boisar, Thane 401506 Maharashtra State, India

     VMF Others AUDIT
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    05

    Lisinopril

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

    IOPC
    Not Confirmed
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    Lisinopril

    India

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

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    IOPC
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15098

    Submission : 2000-10-18

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2001-311 - Rev 04

    Issue Date : 2019-09-27

    Type : Chemical

    Substance Number : 1120

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 301MF10069

    Registrant's Address : Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai 400055, India

    Initial Date of Registration : 2019-09-20

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-23

    Valid Till : 2025-07-04

    Written Confirmation Number : WC-0202n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 57297-511

    Start Marketing Date : 2000-10-18

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Hyundai Pharmaceutical Co., Ltd.

    Registration Date : 2025-03-11

    Registration Number : 20250311-209-J-1809

    Manufacturer Name : Lupin Limited

    Manufacturer Address : Unit-2, 198-202, New Industrial Area no. 2, District Raisen Mandideep, Madhya Pradesh 462046, India

     VMF Others AUDIT
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    06

    Quetiapine Hemifumarate

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

    IOPC
    Not Confirmed
    arrow

    Quetiapine Hemifumarate

    India

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

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21513

    Submission : 2008-03-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2016-221 - Rev 01

    Issue Date : 2024-10-21

    Type : Chemical

    Substance Number : 2541

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 223MF10055

    Registrant's Address : Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai 400055, India

    Initial Date of Registration : 2011-04-21

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-09-10

    Written Confirmation Number : WC-0201

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    07

    Simvastatin

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

    IOPC
    Not Confirmed
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    Simvastatin

    India

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

    arrow
    IOPC
    Not Confirmed
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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-03-17

    Pay. Date : 2017-02-28

    DMF Number : 17934

    Submission : 2004-12-27

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2005-100 - Rev 06

    Issue Date : 2020-08-14

    Type : Chemical

    Substance Number : 1563

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 303MF10075

    Registrant's Address : Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai 400055, India

    Initial Date of Registration : 2021-05-10

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-09-10

    Written Confirmation Number : WC-0201

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Masung LS Co., Ltd.

    Registration Date : 2012-06-29

    Registration Number : 20060707-29-B-237-17(4)

    Manufacturer Name : Lupin Limited

    Manufacturer Address : T-142, MIDC, Tarapur, Via Boisar, Maharashtra 401 506, India

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    08

    Zolpidem Tartrate

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

    IOPC
    Not Confirmed
    arrow

    Zolpidem Tartrate

    India

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

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    IOPC
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18430

    Submission : 2005-06-10

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2006-032 - Rev 01

    Issue Date : 2016-09-13

    Type : Chemical

    Substance Number : 1280

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10220

    Registrant's Address : 159, CST Road, Kalina, Santacruz (East) Mumbai-400 098, INDIA

    Initial Date of Registration : 2010-08-16

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-09-10

    Written Confirmation Number : WC-0201

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    09

    Abacavir Sulfate

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

    IOPC
    Not Confirmed
    arrow

    Abacavir Sulfate

    India

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

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    IOPC
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-12-27

    Pay. Date : 2012-11-20

    DMF Number : 23618

    Submission : 2010-04-08

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-342 - Rev 00

    Issue Date : 2022-02-24

    Type : Chemical

    Substance Number : 2589

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10171

    Registrant's Address : Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai 400055, India

    Initial Date of Registration : 2017-08-28

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    10

    Cefaclor

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

    IOPC
    Not Confirmed
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    Cefaclor

    India

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

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    IOPC
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12086

    Submission : 1996-08-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2001-359 - Rev 05

    Issue Date : 2018-06-12

    Type : Chemical

    Substance Number : 986

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-27

    Valid Till : 2025-07-31

    Written Confirmation Number : WC-0048n

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Big Farms Co., Ltd.

    Registration Date : 2019-08-29

    Registration Number : 20050831-20-A-21-05(22)

    Manufacturer Name : Lupin Ltd.

    Manufacturer Address : Unit-1, 198-202, New Industrial area No.2 Dist. - Raisen Mandideep Madhya Pradesh 462046, India

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