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    01 1Albendazole

    02 1Alfuzosin HCl

    03 3Alogliptin Benzoate

    04 1Amlodipine

    05 2Amlodipine Besylate

    06 1Anagrelide Hydrochloride

    07 1Anastrozole

    08 1Apalutamide

    09 1Apixaban

    10 1Apremilast

    11 3Aprindine Hydrochloride

    12 1Aripiprazole

    13 1Arsenic Trioxide

    14 1Aspirin

    15 1Atenolol

    16 1Atomoxetin Hydrochloride

    17 5Atorvastatin

    18 1Atovaquone

    19 1Azathioprine

    20 1Azelastine Hydrochloride

    21 1Azelnidipine

    22 3Azilsartan

    23 2Benazepril Hydrochloride

    24 1Benzoyl Peroxide

    25 1Bosentan Hydrate

    26 1Brexpiprazole

    27 1Brivaracetam

    28 2Bupropion Hydrochloride

    29 1Buspirone Hydrochloride

    30 1Calcium Gluconate

    31 1Canagliflozin

    32 2Candesartan Cilexetil

    33 1Capecitabine

    34 2Carvedilol

    35 1Cetilistat

    36 2Chlorthalidone

    37 1Cinacalcet Hydrochloride

    38 1Clindamycin Hydrochloride

    39 1Clindamycin Phosphate

    40 1Clonidine

    41 6Clopidogrel

    42 3Clopidogrel Besylate

    43 1Colestipol

    44 1Dabigatran Etexilate Mesylate

    45 1Daclatasvir

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    47 1Dapagliflozin Propanediol Monohydrate

    48 1Daptomycin

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    50 1Deferiprone

    51 1Desloratadine

    52 2Desvenlafaxine Succinate

    53 1Diclofenac Epolamine

    54 1Dimethyl Fumarate

    55 1Diroximel fumarate

    56 1Donepezil

    57 3Duloxetine Hydrochloride

    58 1Edoxaban Tosylate

    59 1Eltrombopag

    60 1Empagliflozin

    61 1Entecavir

    62 2Enzalutamide

    63 2Erlotinib Hydrochloride

    64 2Escitalopram Oxalate

    65 2Esomeprazole Magnesium

    66 1Esomeprazole Sodium

    67 1Ethacrynic Acid

    68 1Etodolac

    69 1Etoricoxib

    70 2Exemestane

    71 1Famotidine

    72 1Febuxostat

    73 1Fesoterodine

    74 1Fingolimod Hydrochloride

    75 2Fluconazole

    76 1Fluvastatin Sodium

    77 1Gabapentin Enacarbil

    78 2Gatifloxacin

    79 1Gemcitabine

    80 1Glibenclamide

    81 1Glimepiride

    82 1Hydrochlorothiazide

    83 2Hydroxychloroquine Sulphate

    84 3Imatinib Mesylate

    85 1Indacaterol Maleate

    86 2Irbesartan

    87 1Irinotecan Hydrochloride

    88 1Ivabradine Hydrochloride

    89 1Labetalol Hydrochloride

    90 1Lacosamide

    91 1Lamotrigine

    92 2Lansoprazole

    93 1Letermovir

    94 1Letrozole

    95 1Levofloxacin

    96 1Levofloxacin Hemihydrate

    97 1Levomilnacipran

    98 1Linagliptin

    99 1Linezolid

    100 3Loratadine

    101 1Lorcaserin HCl

    102 2Lornoxicam

    103 2Losartan Potassium

    104 1Lumateperone Tosylate

    105 1Lurasidone Hydrochloride

    106 1Macitentan

    107 1Meloxicam

    108 2Memantine Hydrochloride

    109 2Mesalazine

    110 1Metoprolol Succinate

    111 2Midodrine

    112 1Milnacipran HCl

    113 1Mirabegron

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    115 1Nateglinide

    116 1Nicorandil

    117 2Olanzapine

    118 1Olmesartan Medoxomil

    119 2Omeprazole

    120 1Oseltamivir Phosphate

    121 2Otilonium Bromide

    122 1Oxaliplatin

    123 1Paliperidone

    124 1Pantoprazole Magnesium

    125 2Pantoprazole Sodium

    126 4Paroxetine Hydrochloride

    127 1Pentoxifylline

    128 1Perampanel

    129 1Phentermine Hydrochloride

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    132 1Pitavastatin

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    134 3Podophyllotoxin

    135 2Policresulen

    136 1Pramipexole Dihydrochloride

    137 3Pregabalin

    138 1Proguanil

    139 1Promethazine Hydrochloride

    140 1Propafenone Hydrochloride

    141 1Quetiapine Hemifumarate

    142 2Rabeprazole Sodium

    143 2Ranolazine

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    145 1Risperidone

    146 1Rivastigmine

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    148 1Rosuvastatin Calcium

    149 1Salmeterol Xinafoate

    150 1Saxagliptin

    151 1Semaglutide

    152 1Sertraline Hydrochloride

    153 1Silodosin

    154 3Simvastatin

    155 3Sitagliptin Phosphate

    156 1Sofosbuvir

    157 1Solifenacin Succinate

    158 2Succinylcholine Chloride

    159 1Sulfameter

    160 1Suvorexant

    161 1Tamsulosin

    162 1Telmisartan

    163 1Terazosin HCl

    164 1Teriflunomide

    165 1Tirofiban

    166 1Tizanidine HCl

    167 1Tofacitinib Citrate

    168 1Topiramate

    169 2Tramadol Hydrochloride

    170 1Trazodone Hydrochloride

    171 2Urapidil Hydrochloride

    172 1Valacyclovir Hydrochloride

    173 2Valsartan

    174 3Venlafaxine Hydrochloride

    175 1Vilazodone Hydrochloride

    176 1Vildagliptin

    177 1Viloxazine Hydrochloride

    178 1Vortioxetine Hydrobromide

    179 1Voxelotor

    180 1Warfarin Sodium

    181 1Zaleplon

    182 2Ziprasidone Hydrochloride

    183 1Zolpidem Tartrate

    184 1Zonisamide

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    01

    Mesalazine

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

    BioAsia
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    Mesalazine

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-08-08

    Pay. Date : 2012-12-18

    DMF Number : 22999

    Submission : 2009-07-31

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2019-009 - Rev 02

    Issue Date : 2024-07-05

    Type : Chemical

    Substance Number : 1699

    Status : Valid

     JDMF arrow-down
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    Registration Number : 303MF10044

    Registrant's Address : Zydus Corporate Park, 3rd Floor, B Wing, Scheme No. 63, Survey No. 536, Plot No. 103, Nr. Nirma University, Nr. Vaishnod

    Initial Date of Registration : 2021-03-15

    Latest Date of Registration :

    EU-WCarrow-down
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    Date of Issue : 2022-11-11

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0095

    Address of the Firm :

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    02

    Paroxetine Hydrochloride

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

    BioAsia
    Not Confirmed
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    Paroxetine 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 : 16680

    Submission : 2003-06-27

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2004-239 - Rev 07

    Issue Date : 2024-10-28

    Type : Chemical

    Substance Number : 2018

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10207

    Registrant's Address : Zydus Corporate Park, 3rd Floor, B Wing, Scheme No. 63, Survey No. 536, Plot No. 103, Nr. Nirma University, Nr. Vaishnod

    Initial Date of Registration : 2010-07-26

    Latest Date of Registration :

    EU-WCarrow-down
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    Date of Issue : 2022-11-11

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0095

    Address of the Firm :

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    Registrant Name : Nuri Pharm Tech

    Registration Date : 2021-11-30

    Registration Number : 20211130-209-J-1162

    Manufacturer Name : Zydus Lifesciences Limited

    Manufacturer Address : 291, GIDC, Estate, Ankleshwar, Gujarat, 393002, India

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    03

    Tramadol Hydrochloride

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

    BioAsia
    Not Confirmed
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    Tramadol 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 : 17037

    Submission : 2004-02-17

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2004-098 - Rev 05

    Issue Date : 2024-07-16

    Type : Chemical

    Substance Number : 1681

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 301MF10065

    Registrant's Address : “Zydus Tower”, Satellite Cross Roads, Ahmedabad 380015, India

    Initial Date of Registration : 2019-09-17

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-11-11

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0095

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    04

    Losartan Potassium

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

    BioAsia
    Not Confirmed
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    Losartan Potassium

    India

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

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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18153

    Submission : 2005-03-04

    Status : Inactive

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2009-133 - Rev 08

    Issue Date : 2023-03-23

    Type : Chemical

    Substance Number : 2232

    Status : Valid

     JDMF arrow-down
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    Registration Number : 223MF10140

    Registrant's Address : “Zydus Tower”, Satellite Cross Roads, Ahmedabad 380015, India

    Initial Date of Registration : 2011-08-30

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-11-11

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0095

    Address of the Firm :

    NDC KDMF arrow-down
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    Registrant Name : Goodwills Co., Ltd.

    Registration Date : 2011-01-10

    Registration Number : 20110110-122-G-94-29

    Manufacturer Name : Cadila Healthcare Limited

    Manufacturer Address : 291, GIDC Industrial Estate Ankleswar-393 002, Gujarat INDIA

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    05

    Valsartan

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

    BioAsia
    Not Confirmed
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    Valsartan

    India

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

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    BioAsia
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 22684

    Submission : 2009-03-31

    Status : Inactive

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R0-CEP 2020-221 - Rev 00

    Issue Date : 2023-04-04

    Type : Chemical

    Substance Number : 2423

    Status : Valid

     JDMF arrow-down
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    Registration Number : 225MF10140

    Registrant's Address : “Zydus Tower”, Satellite Cross Roads, Ahmedabad 380015, India

    Initial Date of Registration : 2013-07-23

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2023-09-18

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0080

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    06

    Amlodipine Besylate

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

    BioAsia
    Not Confirmed
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    Amlodipine Besylate

    India

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

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    BioAsia
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18827

    Submission : 2005-09-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-280 - Rev 08

    Issue Date : 2022-07-07

    Type : Chemical

    Substance Number : 1491

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-11-11

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0095

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 65841-014

    Start Marketing Date : 2024-09-16

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Agerson Bio Co., Ltd.

    Registration Date : 2021-08-28

    Registration Number : 20130213-130-H-158-43(10)

    Manufacturer Name : Cadila Pharmaceuticals Limited

    Manufacturer Address : 294, GIDC Industrial Estate, Ankleshwar - 393 002, Dist. Bharuch, Gujarat State, India

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    07

    Atomoxetin Hydrochloride

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

    BioAsia
    Not Confirmed
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    Atomoxetin Hydrochloride

    India

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

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    BioAsia
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20364

    Submission : 2007-03-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2019-236 - Rev 01

    Issue Date : 2022-07-11

    Type : Chemical

    Substance Number : 2640

    Status : Valid

     JDMF arrow-down
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    Registration Number : 303MF10088

    Registrant's Address : Zydus Corporate Park, 3rd Floor, B Wing, Scheme No. 63, Survey No. 536, Plot No. 103, Nr. Nirma University, Nr. Vaishnod

    Initial Date of Registration : 2021-06-07

    Latest Date of Registration :

    EU-WC NDC arrow-down
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    NDC Package Code : 65841-155

    Start Marketing Date : 2018-01-12

    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 : Pharmapia Co., Ltd.

    Registration Date : 2016-03-30

    Registration Number : No. 4749-10-ND(1)

    Manufacturer Name : Cadila Pharmaceuticals Limited

    Manufacturer Address : 294, GIDC Estate, City: Ankleshwar-393 002, Dist: Bharuch, India.

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    08

    Atorvastatin

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

    BioAsia
    Not Confirmed
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    Atorvastatin

    India

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

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    BioAsia
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18822

    Submission : 2005-09-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2021-079 - Rev 02

    Issue Date : 2024-08-29

    Type : Chemical

    Substance Number : 2191

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0080

    Address of the Firm :

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    09

    Benzoyl Peroxide

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

    BioAsia
    Not Confirmed
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    Benzoyl Peroxide

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-07-19

    Pay. Date : 2016-06-13

    DMF Number : 23860

    Submission : 2010-06-04

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2018-300 - Rev 02

    Issue Date : 2024-12-11

    Type : Chemical

    Substance Number : 704

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-11-11

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0095

    Address of the Firm :

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    10

    Carvedilol

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

    BioAsia
    Not Confirmed
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    Carvedilol

    India

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

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    BioAsia
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17947

    Submission : 2004-12-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2021-109 - Rev 00

    Issue Date : 2023-05-17

    Type : Chemical

    Substance Number : 1745

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-11-11

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0095

    Address of the Firm :

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    NDC Package Code : 65841-008

    Start Marketing Date : 2024-11-28

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    ✖

    Registrant Name : Withers Pharmaceutical Co., Ltd.

    Registration Date : 2017-12-08

    Registration Number : 20080627-60-B-278-21(3)

    Manufacturer Name : Cadila Pharmaceuticals Limited.

    Manufacturer Address : 294, GIDC, Industrial Estate, Ankleshwar-393 002, Gujarat, India

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