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    01 1Abacavir

    02 1Abiraterone Acetate

    03 1Acalabrutinib

    04 1Adagrasib

    05 1Agomelatine

    06 1Amlodipine Besylate

    07 1Amtolmetin Guacil

    08 2Apalutamide

    09 1Apixaban

    10 2Apremilast

    11 1Asenapine Maleate

    12 3Atomoxetin Hydrochloride

    13 6Atorvastatin

    14 1Azacitidine

    15 1Belumosudil

    16 1Bempedoic Acid

    17 1Bendamustine Hydrochloride

    18 1Benztropine

    19 1Bortezomib

    20 1Brigatinib

    21 1Cabazitaxel

    22 3Cabozantinib

    23 2Capecitabine

    24 1Carfilzomib

    25 2Cetirizine Dihydrochloride

    26 1Cinacalcet Hydrochloride

    27 1Ciprofloxacin Hydrochloride

    28 2Clopidogrel

    29 1Dabigatran Etexilate Mesylate

    30 1Dapagliflozin

    31 1Dapagliflozin Propanediol Monohydrate

    32 1Darolutamide

    33 2Dasatinib

    34 2Decitabine

    35 1Desloratadine

    36 1Deucravacitinib

    37 1Dimethyl Fumarate

    38 1Divalproex Sodium

    39 1Donepezil

    40 1Doxazosin Mesylate

    41 1Duloxetine Hydrochloride

    42 1Dutasteride

    43 1Edaravone

    44 1Edoxaban Tosylate

    45 1Elagolix Sodium

    46 1Eliglustat

    47 1Enzalutamide

    48 2Eribulin

    49 1Escitalopram Oxalate

    50 1Eslicarbazepine Acetate

    51 4Esomeprazole Magnesium

    52 1Eszopiclone

    53 1Etrasimod

    54 1Ezetimibe

    55 1Famotidine

    56 1Febuxostat

    57 1Ferric Carboxymaltose

    58 2Fexofenadine Hydrochloride

    59 1Fezolinetant

    60 1Finasteride

    61 1Finerenone

    62 1Fingolimod Hydrochloride

    63 1Fluconazole

    64 1Fondaparinux Sodium

    65 1Fosaprepitant

    66 1Fosphenytoin Sodium

    67 1Fruquintinib

    68 1Gatifloxacin

    69 1Gemcitabine

    70 1Glatiramer Acetate

    71 1Glimepiride

    72 1Granisetron

    73 1Granisetron Hydrochloride

    74 1Ibandronate Sodium

    75 1Irbesartan

    76 1Iron Sucrose

    77 2Ketorolac Trometamol

    78 1Lacidipine

    79 1Lanreotide Acetate

    80 1Lansoprazole

    81 3Lenalidomide

    82 2Lenvatinib Mesylate

    83 1Letrozole

    84 1Levetiracetam

    85 2Levocetirizine Dihydrochloride

    86 1Levofloxacin Hemihydrate

    87 1Lifitegrast

    88 1Linagliptin

    89 1Liraglutide

    90 1Lomustine

    91 2Losartan Potassium

    92 1Lubiprostone

    93 1Lumateperone Tosylate

    94 1Lurasidone Hydrochloride

    95 1Mavacamten

    96 1Memantine Hydrochloride

    97 1Metaraminol Bitartrate

    98 2Metoprolol Succinate

    99 2Midostaurin

    100 2Mirabegron

    101 1Mirogabalin Besylate

    102 1Montelukast Sodium

    103 1Moxifloxacin Hydrochloride

    104 3Naproxen

    105 2Naproxen Sodium

    106 1Naratriptan

    107 1Naratriptan Hydrochloride

    108 2Nilotinib

    109 1Niraparib Tosylate

    110 1Nizatidine

    111 1Olaparib

    112 3Omeprazole

    113 2Omeprazole Magnesium

    114 1Ondansetron

    115 2Ondansetron Hydrochloride

    116 1Oxaprozin

    117 1Palbociclib

    118 1Palonosetron

    119 2Pantoprazole Sodium

    120 1Pazopanib Hydrochloride

    121 2Pemetrexed Disodium

    122 1Pemetrexed Ditromethamine

    123 1Perfluorohexyloctane

    124 1Permethrin

    125 1Pioglitazone Hydrochloride

    126 1Pirtobrutinib

    127 1Plerixafor

    128 1Pomalidomide

    129 1Posaconazole

    130 1Prasugrel

    131 1Prasugrel Hydrochloride

    132 2Pregabalin

    133 1Quetiapine Hemifumarate

    134 3Rabeprazole

    135 1Raloxifene Hydrochloride

    136 1Ramipril

    137 1Ranolazine

    138 1Rasagiline Mesylate

    139 1Rasagiline Tartrate

    140 1Relugolix

    141 1Resmetirom

    142 1Ripretinib

    143 1Risperidone

    144 1Ritlecitinib

    145 1Rivaroxaban

    146 2Rivastigmine Tartrate

    147 1Ropinirole

    148 2Roxadustat

    149 1Sacubitril-Valsartan

    150 1Salcaprozate Sodium

    151 1Sertraline Hydrochloride

    152 1Sildenafil Citrate

    153 1Siponimod fumarate

    154 2Sitagliptin Hydrochloride

    155 1Sitagliptin Malate

    156 2Sitagliptin Phosphate

    157 1Solifenacin Succinate

    158 1Sugammadex Sodium

    159 2Sumatriptan

    160 1Tafamidis Meglumine

    161 1Terbinafine Hydrochloride

    162 1Testosterone

    163 1Ticagrelor

    164 1Tizanidine HCl

    165 1Tofacitinib Citrate

    166 1Tolterodine Tartrate

    167 1Travoprost

    168 1Treprostinil Diolamine

    169 1Treprostinil Sodium

    170 1Tucatinib

    171 1Valganciclovir Hydrochloride

    172 2Valsartan

    173 1Varenicline Tartrate

    174 1Venetoclax

    175 1Vilazodone Hydrochloride

    176 1Voclosporin

    177 1Vonoprazan Fumarate

    178 1Voriconazole

    179 1Zafirlukast

    180 2Ziprasidone Hydrochloride

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    01

    Atorvastatin

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-02-27

    Pay. Date : 2013-02-05

    DMF Number : 18468

    Submission : 2005-06-29

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R0-CEP 2020-092 - Rev 02

    Issue Date : 2023-06-02

    Type : Chemical

    Substance Number : 2191

    Status : Valid

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    Registration Number : 304MF10140

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2022-10-05

    Latest Date of Registration :

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    Date of Issue : 2022-06-15

    Valid Till : 2025-06-16

    Written Confirmation Number : WC-0034

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    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2024-05-01

    Registration Number : 20230331-132-H-410-49(1)

    Manufacturer Name : Dr.Reddy's Laboratories Limited

    Manufacturer Address : CTO-SEZ Process Unit-01 Sector No’s. 28 to 34, 36 to 37, 40, 50 to 53 & 03, Survey No's. 57 to 58, 60, 72 to 73, 76 to 77 & 80, Devunipalavalasa Village, Ranasthalam Mandal, Srikakulam District-532409, Andhra Pradesh, India

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    02

    Capecitabine

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 22479

    Submission : 2009-01-30

    Status : Active

    Type : II

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    Certificate Number : R1-CEP 2014-203 - Rev 00

    Issue Date : 2020-05-07

    Type : Chemical

    Substance Number : 2762

    Status : Valid

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    Registration Number : 304MF10153

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2022-12-07

    Latest Date of Registration :

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    Date of Issue : 2022-06-17

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0067

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    NDC Package Code : 55111-893

    Start Marketing Date : 2012-07-30

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Pami Future Co., Ltd.

    Registration Date : 2024-04-09

    Registration Number : 20240409-209-J-1615

    Manufacturer Name : Dr. Reddy's Laboratories Limited

    Manufacturer Address : CTO Unit-VI, APIIC Industrial Estate, Pydibhimavaram Village, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh - 532 409, India

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    03

    Cetirizine Dihydrochloride

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-06-16

    Pay. Date : 2014-06-06

    DMF Number : 18395

    Submission : 2005-05-27

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2009-206 - Rev 03

    Issue Date : 2020-01-08

    Type : Chemical

    Substance Number : 1084

    Status : Valid

     JDMF arrow-down
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    Registration Number : 218MF10306

    Registrant's Address : 8-2-337, Road No. 3,Banjara Hills,Hyderabad 500 034,TELANGANA,INDIA

    Initial Date of Registration : 2006-04-20

    Latest Date of Registration :

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    Date of Issue : 2022-06-06

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0039

    Address of the Firm :

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    NDC Package Code : 71796-013

    Start Marketing Date : 2005-05-27

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Pami Future Co., Ltd.

    Registration Date : 2022-09-16

    Registration Number : 20050831-40-C-145-06(4)

    Manufacturer Name : Dr. Reddy's Laboratories Limited

    Manufacturer Address : Plot No. 137 & 138, 145 & 146, Sri Venkateswara Co-operative industrial estate,Bollaram, Jinnaram Mandal, Sangareddy District, Telangana state, INDIA

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    04

    Clopidogrel

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-30

    Pay. Date : 2013-01-04

    DMF Number : 16090

    Submission : 2002-08-07

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2012-059 - Rev 02

    Issue Date : 2022-09-27

    Type : Chemical

    Substance Number : 2531

    Status : Valid

     JDMF arrow-down
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    Registration Number : 304MF10059

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2022-03-30

    Latest Date of Registration :

    EU-WCarrow-down
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    Date of Issue : 2022-06-06

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0039

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 55111-946

    Start Marketing Date : 2011-10-03

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Huseeed Co., Ltd.

    Registration Date : 2023-02-13

    Registration Number : 20110225-129-H-88-15(15)

    Manufacturer Name : Dr. Reddy's Laboratories Limited

    Manufacturer Address : CTO - Unit-I, Plot Nos. 137,138,145 & 146, SV Co-Op, Industrial Estate, Bollaram Village, Jinnaram Mandal, Sangareddy District, Telangana - 502 325, INDIA

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    05

    Clopidogrel

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2022-02-15

    Pay. Date : 2022-01-11

    DMF Number : 35506

    Submission : 2020-12-30

    Status : Active

    Type : II

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    Certificate Number : R0-CEP 2021-052 - Rev 01

    Issue Date : 2023-02-20

    Type : Chemical

    Substance Number : 2531

    Status : Valid

     JDMF arrow-down
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    Registration Number : 303MF10053

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2021-03-26

    Latest Date of Registration :

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    Date of Issue : 2022-06-08

    Valid Till : 2025-06-04

    Written Confirmation Number : WC-0043Amended

    Address of the Firm :

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    NDC Package Code : 55111-946

    Start Marketing Date : 2011-10-03

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Huseeed Co., Ltd.

    Registration Date : 2023-02-13

    Registration Number : 20110225-129-H-88-15(15)

    Manufacturer Name : Dr. Reddy's Laboratories Limited

    Manufacturer Address : CTO - Unit-I, Plot Nos. 137,138,145 & 146, SV Co-Op, Industrial Estate, Bollaram Village, Jinnaram Mandal, Sangareddy District, Telangana - 502 325, INDIA

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    06

    Fexofenadine Hydrochloride

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2020-12-12

    Pay. Date : 2020-12-04

    DMF Number : 15757

    Submission : 2001-12-05

    Status : Active

    Type : II

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    Certificate Number : R0-CEP 2021-067 - Rev 00

    Issue Date : 2023-07-06

    Type : Chemical

    Substance Number : 2280

    Status : Valid

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    Registration Number : 302MF10124

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2020-10-05

    Latest Date of Registration :

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    Date of Issue : 2022-06-08

    Valid Till : 2025-06-04

    Written Confirmation Number : WC-0043Amended

    Address of the Firm :

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    Registrant Name : Sangjin Corporation

    Registration Date : 2022-10-06

    Registration Number : 20221006-209-J-1373

    Manufacturer Name : Dr. Reddy's Laboratories Ltd.

    Manufacturer Address : Peddadevulapalli Village, Tripuraram Mandal, Nalgonda District, Telangana State, India - 508207

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    07

    Finasteride

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16010

    Submission : 2002-06-11

    Status : Active

    Type : II

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    Certificate Number : R1-CEP 2009-195 - Rev 03

    Issue Date : 2023-07-12

    Type : Chemical

    Substance Number : 1615

    Status : Valid

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    Registration Number : 226MF10054

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2014-03-06

    Latest Date of Registration :

    EU-WCarrow-down
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    Date of Issue : 2022-06-15

    Valid Till : 2025-06-16

    Written Confirmation Number : WC-0034

    Address of the Firm :

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    Registrant Name : Sangjin Corporation

    Registration Date : 2008-11-28

    Registration Number : 20081128-94-E-29-06

    Manufacturer Name : Dr. Reddy's Laboratories Ltd.,

    Manufacturer Address : Plot No. 110 & 111, SVCo.operative Industrial Estate, Bollaram Village, _x000D_ Jinnaram Mandal, Medak District, Telangana State

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    08

    Gemcitabine

    India

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-06-27

    Pay. Date : 2016-06-06

    DMF Number : 18857

    Submission : 2005-10-11

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2007-075 - Rev 06

    Issue Date : 2021-06-18

    Type : Chemical

    Substance Number : 2306

    Status : Valid

     JDMF arrow-down
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    Registration Number : 220MF10243

    Registrant's Address : 8-2-337, Road No. 3,Banjara Hills,Hyderabad 500 034,TELANGANA,INDIA

    Initial Date of Registration : 2008-12-04

    Latest Date of Registration :

    EU-WCarrow-down
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    Date of Issue : 2022-06-06

    Valid Till : 2025-07-07

    Written Confirmation Number : WC-0039

    Address of the Firm :

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    Registrant Name : Korea United Pharmaceutical Co., Ltd.

    Registration Date : 2012-05-18

    Registration Number : 20070928-86-D-51-03(3)

    Manufacturer Name : Dr. Reddy's Laboratories Limited

    Manufacturer Address : CTO - Unit-I, Plot Nos. 137,138,145 & 146, SV Co-Op, Industrial Estate, Bollaram Village, Jinnaram Mandal, Sangareddy District, Telangana - 502 325, INDIA

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    09

    Levetiracetam

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-30

    Pay. Date : 2013-01-02

    DMF Number : 16966

    Submission : 2003-11-17

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2011-084 - Rev 01

    Issue Date : 2018-05-16

    Type : Chemical

    Substance Number : 2535

    Status : Valid

     JDMF arrow-down
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    Registration Number : 302MF10034

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

    Initial Date of Registration : 2020-03-09

    Latest Date of Registration :

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    Date of Issue : 2022-06-17

    Valid Till : 2025-07-07

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    NDC Package Code : 55111-870

    Start Marketing Date : 2003-11-17

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Sangjin Corporation

    Registration Date : 2021-02-17

    Registration Number : 20210217-183-I-616-29

    Manufacturer Name : Dr. Reddy's Laboratories Limited

    Manufacturer Address : CTO Unit-VI, APIIC Industrial Estate, Pydibhimavaram Village, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh - 532 409, India

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-09-04

    Pay. Date : 2013-08-23

    DMF Number : 14036

    Submission : 1999-03-16

    Status : Active

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    Certificate Number : R1-CEP 2002-027 - Rev 06

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    Substance Number : 1453

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    Registration Number : 218MF10215

    Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

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    Date of Issue : 2022-06-17

    Valid Till : 2025-07-07

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    NDC Package Code : 55111-011

    Start Marketing Date : 2012-07-13

    End Marketing Date : 2024-12-31

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    Registrant Name : Bansen Co., Ltd.

    Registration Date : 2021-05-28

    Registration Number : 20121220-144-I-186-02(14)

    Manufacturer Name : Dr. Reddy's Laboratories Limited

    Manufacturer Address : APIIC Industrial Estate, Pydibhimavaram, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh, India

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