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

    02 17-Aminodesacetoxycephalosporanic Acid

    03 2Abacavir Sulfate

    04 1Acotiamide

    05 1Alendronate Sodium

    06 1Amlodipine Besylate

    07 2Apremilast

    08 1Armodafinil

    09 1Asenapine Maleate

    10 2Atazanavir Sulfate

    11 3Atorvastatin

    12 1Azilsartan

    13 2Azithromycin

    14 1Azithromycin Dihydrate

    15 1Bedaquiline

    16 1Bempedoic Acid

    17 2Benazepril Hydrochloride

    18 1Bicalutamide

    19 1Bictegravir

    20 1Bictegravir Sodium

    21 1Bimatoprost

    22 1Brexpiprazole

    23 1Brimonidine Tartrate

    24 1Brivaracetam

    25 1Bupropion Hydrobromide

    26 1Bupropion Hydrochloride

    27 1Calcium

    28 2Canagliflozin

    29 1Cannabidiol

    30 1Carvedilol

    31 1Carvedilol Phosphate

    32 2Cefaclor

    33 1Cefadroxil

    34 1Cefadroxil Monohydrate

    35 1Cefdinir

    36 1Cefditoren Pivoxil

    37 2Cefepime Hydrochloride

    38 1Cefixime

    39 1Cefotaxime

    40 1Cefpodoxime Proxetil

    41 1Cefprozil

    42 1Ceftriaxone

    43 3Cefuroxime Axetil

    44 2Celecoxib

    45 2Cephalexin

    46 1Cephalexin Monohydrate

    47 1Choline Fenofibrate

    48 1Cinacalcet Hydrochloride

    49 1Clindamycin Palmitate

    50 1Clofazimine

    51 1Clopidogrel

    52 1Colesevelam Hydrochloride

    53 1Cysteamine Bitartrate

    54 1Dabigatran Etexilate Mesylate

    55 1Dalbavancin

    56 1Dapagliflozin

    57 1Dapagliflozin Propanediol Monohydrate

    58 2Darunavir

    59 2Darunavir Ethanolate

    60 1Delamanid

    61 1Desloratadine

    62 1Desogestrel

    63 1Desvenlafaxine Benzoate

    64 1Desvenlafaxine Succinate

    65 1Deutetrabenazine

    66 1Dexlansoprazole

    67 1Dienogest

    68 2Dolutegravir Sodium

    69 1Donepezil

    70 1Doxcercalciferol

    71 1Dronedarone Hydrochloride

    72 1Drospirenone

    73 1Droxidopa

    74 2Duloxetine Hydrochloride

    75 1Efavirenz

    76 1Efinaconazole

    77 1Elagolix Sodium

    78 1Empagliflozin

    79 1Emtricitabine

    80 1Escitalopram Oxalate

    81 1Eslicarbazepine Acetate

    82 1Esomeprazole Magnesium

    83 1Estradiol

    84 1Estradiol Valerate

    85 1Eszopiclone

    86 1Ethambutol

    87 2Ethambutol Dihydrochloride

    88 1Ethinyl Estradiol

    89 3Ezetimibe

    90 2Febuxostat

    91 2Fenofibrate

    92 2Ferric Citrate

    93 1Fesoterodine

    94 1Flupirtine

    95 1Fluticasone Furoate

    96 1Fluticasone Propionate

    97 1Fluvastatin Sodium

    98 1Fosamprenavir

    99 1Gatifloxacin

    100 1Glipizide

    101 1Glycerol Phenylbutyrate

    102 1Hydrocortisone Valerate

    103 1Idelalisib

    104 1Ilaprazole

    105 1Iloperidone

    106 1Imipramine

    107 1Imipramine Hydrochloride

    108 2Irbesartan

    109 2Iron Sucrose

    110 1Ivacaftor

    111 1Lacosamide

    112 2Lamivudine

    113 1Lamotrigine

    114 1Lansoprazole

    115 1Latanoprost

    116 1Ledipasvir

    117 1Letermovir

    118 4Levetiracetam

    119 1Levofloxacin

    120 1Levofloxacin Hemihydrate

    121 1Levomefolate Calcium

    122 2Levonorgestrel

    123 1Levothyroxine Sodium

    124 2Lisinopril

    125 1Lopinavir

    126 1Lorcaserin HCl

    127 2Losartan Potassium

    128 3Lovastatin

    129 1Lurasidone Hydrochloride

    130 1Memantine Hydrochloride

    131 2Mesalazine

    132 1Metaxalone

    133 1Metformin

    134 1Methylprednisolone Sodium Succinate

    135 1Migalastat

    136 1Milnacipran Hydrochloride

    137 1Mirabegron

    138 1Nabumetone

    139 1Nimorazole

    140 1Norethisterone

    141 1Norethisterone Acetate

    142 1Norgestimate

    143 1Olmesartan Medoxomil

    144 2Omeprazole

    145 1Omeprazole Magnesium

    146 1Oseltamivir Phosphate

    147 1Paliperidone

    148 1Pantoprazole Sodium

    149 1Perindopril Erbumine

    150 1Pioglitazone Hydrochloride

    151 1Pirfenidone

    152 1Piribedil

    153 2Pitavastatin

    154 1Potassium Warfarin

    155 1Prasugrel Hydrochloride

    156 2Pregabalin

    157 1Propranolol Hydrochloride

    158 1Pyrazinamide

    159 1Quetiapine Hemifumarate

    160 1Quinapril

    161 1Rabeprazole

    162 2Raltegravir Potassium

    163 2Ramipril

    164 1Ranolazine

    165 2Rifabutin

    166 1Rifampicin

    167 2Rifamycin

    168 1Rifapentine

    169 2Rifaximin

    170 1Risperidone

    171 3Ritonavir

    172 1Rivaroxaban

    173 2Rosuvastatin Calcium

    174 1Rufinamide

    175 1Sacubitril Sodium

    176 1Sacubitril-Valsartan

    177 1Salbutamol Sulphate

    178 1Sertraline Hydrochloride

    179 1Sevelamer Carbonate

    180 1Sevelamer Hydrochloride

    181 1Simvastatin

    182 1Sitagliptin Phosphate

    183 1Sodium Zirconium Cyclosilicate

    184 1Sofosbuvir

    185 1Tacrolimus

    186 1Telmisartan

    187 1Teneligliptin Hydrobromide

    188 1Tenofovir Alafenamide

    189 2Tenofovir Alafenamide Fumarate

    190 1Tenofovir Disoproxil Fumarate

    191 1Testosterone

    192 1Tiotropium Bromide

    193 1Tolterodine Tartrate

    194 1Tolvaptan

    195 1Topiramate

    196 1Trandolapril

    197 1Travoprost

    198 1Umeclidinium Bromide

    199 1Valacyclovir Hydrochloride

    200 1Valbenazine Tosylate

    201 1Valsartan

    202 1Varenicline Tartrate

    203 1Venlafaxine Hydrochloride

    204 1Vilanterol Trifenatate

    205 1Vilazodone Hydrochloride

    206 1Vortioxetine Hydrobromide

    207 1Ziprasidone Hydrochloride

    208 1Zolpidem Tartrate

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    01

    Abacavir Sulfate

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

    Pharmtech & Ingredients
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    Abacavir Sulfate

    India

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

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

    Issue Date : 2022-02-24

    Type : Chemical

    Substance Number : 2589

    Status : Valid

     JDMF arrow-down
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    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-WCarrow-down
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-09-10

    Written Confirmation Number : WC-0201

    Address of the Firm :

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    02

    Amlodipine Besylate

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

    Pharmtech & Ingredients
    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
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    Certificate Number : R1-CEP 2006-031 - Rev 02

    Issue Date : 2017-05-05

    Type : Chemical

    Substance Number : 1491

    Status : Valid

     JDMF arrow-down
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    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
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    Date of Issue : 2022-09-30

    Valid Till : 2025-09-10

    Written Confirmation Number : WC-0201

    Address of the Firm :

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    03

    Duloxetine Hydrochloride

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

    Pharmtech & Ingredients
    Not Confirmed
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    Duloxetine Hydrochloride

    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 : 21524

    Submission : 2008-04-08

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2015-144 - Rev 00

    Issue Date : 2022-03-17

    Type : Chemical

    Substance Number : 2594

    Status : Valid

     JDMF arrow-down
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    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
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    Date of Issue : 2022-09-30

    Valid Till : 2025-09-10

    Written Confirmation Number : WC-0201

    Address of the Firm :

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    04

    Ethambutol Dihydrochloride

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

    Pharmtech & Ingredients
    Not Confirmed
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    Ethambutol Dihydrochloride

    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 : 20404

    Submission : 2007-03-30

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2000-019 - Rev 06

    Issue Date : 2021-03-18

    Type : Chemical

    Substance Number : 553

    Status : Valid

     JDMF arrow-down
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    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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    05

    Levetiracetam

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

    Pharmtech & Ingredients
    Not Confirmed
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    Levetiracetam

    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 : 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
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    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
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    Date of Issue : 2022-09-30

    Valid Till : 2025-09-10

    Written Confirmation Number : WC-0201

    Address of the Firm :

    NDC KDMF arrow-down
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    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

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    06

    Quetiapine Hemifumarate

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

    Pharmtech & Ingredients
    Not Confirmed
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    Quetiapine Hemifumarate

    India

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

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    Pharmtech & Ingredients
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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
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    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
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    Date of Issue : 2022-09-30

    Valid Till : 2025-09-10

    Written Confirmation Number : WC-0201

    Address of the Firm :

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    07

    Simvastatin

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

    Pharmtech & Ingredients
    Not Confirmed
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    Simvastatin

    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 : 2017-03-17

    Pay. Date : 2017-02-28

    DMF Number : 17934

    Submission : 2004-12-27

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2005-100 - Rev 06

    Issue Date : 2020-08-14

    Type : Chemical

    Substance Number : 1563

    Status : Valid

     JDMF arrow-down
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    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
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    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

    Pharmtech & Ingredients
    Not Confirmed
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    Zolpidem Tartrate

    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 : 18430

    Submission : 2005-06-10

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2006-032 - Rev 01

    Issue Date : 2016-09-13

    Type : Chemical

    Substance Number : 1280

    Status : Valid

     JDMF arrow-down
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    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 :

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    09

    Lisinopril

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

    Pharmtech & Ingredients
    Not Confirmed
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    Lisinopril

    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 : 15098

    Submission : 2000-10-18

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2001-311 - Rev 04

    Issue Date : 2019-09-27

    Type : Chemical

    Substance Number : 1120

    Status : Valid

     JDMF arrow-down
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    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-WCInactive-api
    ✖

    Date of Issue : 2019-07-05

    Valid Till : 2022-07-04

    Written Confirmation Number : WC-0202

    Address of the Firm :

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    NDC Package Code : 57297-511

    Start Marketing Date : 2000-10-18

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    10

    Risperidone

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

    Pharmtech & Ingredients
    Not Confirmed
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    Risperidone

    India

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

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    Pharmtech & Ingredients
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19267

    Submission : 2006-03-16

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-160 - Rev 01

    Issue Date : 2016-09-13

    Type : Chemical

    Substance Number : 1559

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10118

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

    Initial Date of Registration : 2010-04-01

    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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