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    01 1Abacavir Sulfate

    02 1Abiraterone Acetate

    03 1Acalabrutinib

    04 1Acoramidis Hydrochloride

    05 1Adagrasib

    06 1Alendronate Sodium

    07 10Amlodipine Besylate

    08 1Anastrozole

    09 2Apalutamide

    10 2Apixaban

    11 2Apremilast

    12 1Aprepitant

    13 1Asenapine Maleate

    14 1Atomoxetine

    15 8Atorvastatin

    16 1Azacitidine

    17 1Bazedoxifene Acetate

    18 1Belumosudil

    19 1Bempedoic Acid

    20 1Bendamustine Hydrochloride

    21 1Benztropine

    22 1Bivalirudin

    23 1Bortezomib

    24 1Brensocatib

    25 1CAS 654671-77-9

    26 1Cabazitaxel

    27 3Cabozantinib

    28 1Canagliflozin

    29 2Capecitabine

    30 1Capivasertib

    31 1Carfilzomib

    32 1Carvedilol

    33 1Cetirizine

    34 4Cetirizine Dihydrochloride

    35 1Cinacalcet Hydrochloride

    36 1Ciprofloxacin Hydrochloride

    37 1Citalopram Hydrobromide

    38 16Clopidogrel

    39 1Clopidogrel Besylate

    40 1Clopidogrel Hydrochloride

    41 2Dabigatran Etexilate Mesylate

    42 1Dapagliflozin

    43 3Dapagliflozin Propanediol Monohydrate

    44 1Darolutamide

    45 2Dasatinib

    46 2Decitabine

    47 1Desloratadine

    48 1Deucravacitinib

    49 2Dexlansoprazole

    50 1Dimethyl Fumarate

    51 1Diroximel fumarate

    52 1Divalproex Sodium

    53 1Donepezil

    54 1Doxazosin Mesylate

    55 1Duloxetine Hydrochloride

    56 4Dutasteride

    57 1Edaravone

    58 1Edoxaban Tosylate

    59 1Elagolix Sodium

    60 1Elinzanetant

    61 6Empagliflozin

    62 1Enalapril Maleate

    63 3Enzalutamide

    64 2Eribulin

    65 1Escitalopram Oxalate

    66 1Eslicarbazepine Acetate

    67 4Esomeprazole Magnesium

    68 1Eszopiclone

    69 1Everolimus

    70 1Ezetimibe

    71 1Famotidine

    72 1Febuxostat

    73 1Ferric Carboxymaltose

    74 2Fexofenadine Hydrochloride

    75 1Finasteride

    76 1Fluconazole

    77 1Fluoxetine Hydrochloride

    78 1Fondaparinux Sodium

    79 1Fosaprepitant

    80 1Fruquintinib

    81 1Galantamine Hydrobromide

    82 1Gatifloxacin

    83 3Gemcitabine

    84 1Glatiramer Acetate

    85 1Glimepiride

    86 1Granisetron

    87 1Hydroxychloroquine Sulphate

    88 2Ibandronate Sodium

    89 1Ibrutinib

    90 1Icatibant Acetate

    91 1Imatinib Mesylate

    92 1Iptacopan Hydrochloride

    93 1Irbesartan

    94 1Iron Sucrose

    95 9Ketorolac Trometamol

    96 1Lacidipine

    97 3Lenalidomide

    98 2Lenvatinib Mesylate

    99 1Letrozole

    100 1Levetiracetam

    101 1Levocetirizine Dihydrochloride

    102 1Levofloxacin Hemihydrate

    103 1Lifitegrast

    104 1Linagliptin

    105 1Linezolid

    106 1Liraglutide

    107 1Lomustine

    108 2Losartan Potassium

    109 1Lubiprostone

    110 1Lumateperone Tosylate

    111 1Lurasidone Hydrochloride

    112 1Memantine Hydrochloride

    113 2Metoprolol Succinate

    114 2Midostaurin

    115 1Milnacipran Hydrochloride

    116 2Mirabegron

    117 1Montelukast Sodium

    118 3Moxifloxacin Hydrochloride

    119 3Naproxen

    120 3Naproxen Sodium

    121 1Naratriptan Hydrochloride

    122 1Nateglinide

    123 1Nicotinamide Riboside Chloride

    124 3Nilotinib

    125 10Nizatidine

    126 1Olanzapine

    127 1Olaparib

    128 4Omeprazole

    129 2Omeprazole Magnesium

    130 1Ondansetron

    131 2Ondansetron Hydrochloride

    132 1Orforglipron Calcium Hydrate

    133 1Oxaprozin

    134 1Palbociclib

    135 1Paliperidone

    136 1Paliperidone Palmitate

    137 1Palonosetron

    138 4Pantoprazole Sodium

    139 1Pazopanib Hydrochloride

    140 2Pemetrexed Disodium

    141 1Pemetrexed Ditromethamine

    142 1Perfluorohexyloctane

    143 1Permethrin

    144 1Pioglitazone

    145 1Pioglitazone Hydrochloride

    146 1Pirtobrutinib

    147 1Plerixafor

    148 1Pomalidomide

    149 1Posaconazole

    150 1Prasugrel Hydrochloride

    151 5Pregabalin

    152 1Primidone

    153 1Quetiapine Hemifumarate

    154 3Rabeprazole Sodium

    155 1Raloxifene Hydrochloride

    156 1Ramipril

    157 2Ranitidine Hydrochloride

    158 1Ranolazine

    159 1Rasagiline Mesylate

    160 1Relugolix

    161 1Resmetirom

    162 1Ripretinib

    163 2Risperidone

    164 1Ritonavir

    165 2Rivaroxaban

    166 2Rivastigmine Tartrate

    167 1Ropinirole

    168 1Ropinirole Hydrochloride

    169 1Rosiglitazone Maleate

    170 2Roxadustat

    171 2Sacubitril-Valsartan

    172 1Saxagliptin Hydrochloride

    173 1Seladelpar Lysine

    174 1Semaglutide

    175 1Siponimod

    176 1Siponimod fumarate

    177 2Sitagliptin Hydrochloride

    178 1Sitagliptin Malate

    179 3Sitagliptin Phosphate

    180 1Solifenacin Succinate

    181 2Sugammadex Sodium

    182 2Sumatriptan

    183 1Tafamidis

    184 3Terbinafine Hydrochloride

    185 1Testosterone

    186 1Ticagrelor

    187 2Tizanidine Hydrochloride

    188 1Tofacitinib Citrate

    189 1Tolterodine Tartrate

    190 1Topiramate

    191 1Travoprost

    192 1Treprostinil Sodium

    193 3Tucatinib

    194 1Udenafil

    195 1Upadacitinib

    196 2Valganciclovir Hydrochloride

    197 3Valsartan

    198 1Varenicline Tartrate

    199 1Venetoclax

    200 1Venlafaxine Hydrochloride

    201 1Vilazodone Hydrochloride

    202 1Voclosporin

    203 1Vonoprazan Fumarate

    204 1Voriconazole

    205 1Xanomeline

    206 1Zafirlukast

    207 2Ziprasidone Hydrochloride

    208 1Zoledronic Acid

    209 1Zolmitriptan

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    01

    Capecitabine

    India

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 22479

    Submission : 2009-01-30

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2014-109 - Rev 02

    Issue Date : 2022-09-13

    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 : 2025-07-15

    Valid Till : 2028-07-07

    Written Confirmation Number : WC-0067

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    NDC Package Code : 55111-893

    Start Marketing Date : 2012-07-30

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Pamire 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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    02

    Clopidogrel

    India

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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

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

    Issue Date : 2023-02-20

    Type : Chemical

    Substance Number : 2531

    Status : Valid

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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 :

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    Date of Issue : 2025-06-20

    Valid Till : 2028-07-07

    Written Confirmation Number : WC-0039

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    NDC Package Code : 71796-027

    Start Marketing Date : 2020-12-30

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Agerson Bio Co., Ltd.

    Registration Date : 2025-02-05

    Registration Number : 20110225-129-H-88-15(17)

    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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    03

    Fexofenadine Hydrochloride

    India

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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 : 2025-07-25

    Valid Till : 2028-06-04

    Written Confirmation Number : WC-0043

    Address of the Firm :

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    Registrant Name : Sangjin Trading Co., Ltd.

    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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    04

    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 : 2025-06-20

    Valid Till : 2028-07-07

    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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    05

    Montelukast Sodium

    India

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-02-18

    Pay. Date : 2012-12-31

    DMF Number : 24516

    Submission : 2010-12-31

    Status : Active

    Type : II

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    Certificate Number : R1-CEP 2012-115 - Rev 03

    Issue Date : 2023-07-12

    Type : Chemical

    Substance Number : 2583

    Status : Valid

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    Registration Number : 307MF10039

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

    Initial Date of Registration : 2025-02-26

    Latest Date of Registration :

    EU-WCarrow-down
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    Date of Issue : 2025-07-25

    Valid Till : 2028-06-04

    Written Confirmation Number : WC-0043

    Address of the Firm :

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    NDC Package Code : 55111-084

    Start Marketing Date : 2010-12-31

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Pamire Co., Ltd.

    Registration Date : 2022-06-29

    Registration Number : 20220629-209-J-1272

    Manufacturer Name : Dr. Reddy's Laboratories Ltd.

    Manufacturer Address : Chemical Technical Operations-Unit-Ⅴ, Peddadevulapally Village, Tripuraram Mandal, Nalgonda District, 508 207, Telangana State, India

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    06

    Nizatidine

    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

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2002-027 - Rev 06

    Issue Date : 2023-04-24

    Type : Chemical

    Substance Number : 1453

    Status : Valid

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    Registration Number : 218MF10215

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

    Initial Date of Registration : 2006-02-16

    Latest Date of Registration :

    EU-WCarrow-down
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    Date of Issue : 2025-07-15

    Valid Till : 2028-07-07

    Written Confirmation Number : WC-0067

    Address of the Firm :

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    NDC Package Code : 55111-011

    Start Marketing Date : 2012-07-13

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Narsha Farm Co., Ltd.

    Registration Date : 2019-03-13

    Registration Number : 20121220-144-I-186-02(13)

    Manufacturer Name : Dr.Reddy's Laboratories Limited

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

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    07

    Ondansetron Hydrochloride

    India

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-09-23

    Pay. Date : 2015-09-09

    DMF Number : 15436

    Submission : 2001-05-15

    Status : Active

    Type : II

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    Certificate Number : R1-CEP 2005-071 - Rev 06

    Issue Date : 2023-05-23

    Type : Chemical

    Substance Number : 2016

    Status : Valid

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    Registration Number : 302MF10019

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

    Initial Date of Registration : 2020-01-31

    Latest Date of Registration :

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    Date of Issue : 2025-07-25

    Valid Till : 2028-06-04

    Written Confirmation Number : WC-0043

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    NDC Package Code : 55111-017

    Start Marketing Date : 2010-01-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Sangjin Trading Co., Ltd.

    Registration Date : 2021-06-22

    Registration Number : 20210426-47-B-440-20(1)

    Manufacturer Name : Dr. Reddy's Laboratories Ltd.

    Manufacturer Address : Peddadevulapally Village, Tripuraram Mandal, Nalgonda District - 508 207, Telangana State, India

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    08

    Quetiapine Hemifumarate

    India

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17122

    Submission : 2004-01-29

    Status : Active

    Type : II

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    Certificate Number : CEP 2014-200 - Rev 01

    Issue Date : 2024-03-15

    Type : Chemical

    Substance Number : 2541

    Status : Valid

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    Registration Number : 306MF10157

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

    Initial Date of Registration : 2024-12-11

    Latest Date of Registration :

    EU-WCarrow-down
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    Date of Issue : 2025-07-15

    Valid Till : 2028-07-07

    Written Confirmation Number : WC-0067

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    NDC Package Code : 55111-053

    Start Marketing Date : 2004-01-29

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Sangjin Trading Co., Ltd.

    Registration Date : 2012-06-28

    Registration Number : 20120628-172-I-86-04

    Manufacturer Name : Dr. Reddy's Laboratories Limited

    Manufacturer Address : Chemical Technical Operations, Unit-VI, APIIC Industrial Estate, Pydibhimavaram, Ranasthalam Mandal, Srikakulam District - 532409, Andhra Pradesh, India.

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    09

    Rabeprazole Sodium

    India

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    NDC Package Code : 55111-055

    Start Marketing Date : 2010-01-30

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    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2013-01-31

    Registration Number : 20121210-10-C-303-19(1)

    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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