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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 2Dabigatran Etexilate Mesylate

    41 1Dapagliflozin

    42 3Dapagliflozin Propanediol Monohydrate

    43 1Darolutamide

    44 2Dasatinib

    45 2Decitabine

    46 1Desloratadine

    47 1Deucravacitinib

    48 2Dexlansoprazole

    49 1Dimethyl Fumarate

    50 1Diroximel fumarate

    51 1Divalproex Sodium

    52 1Donepezil

    53 1Doxazosin Mesylate

    54 1Duloxetine Hydrochloride

    55 4Dutasteride

    56 1Edaravone

    57 1Edoxaban Tosylate

    58 1Elagolix Sodium

    59 1Elinzanetant

    60 6Empagliflozin

    61 1Enalapril Maleate

    62 3Enzalutamide

    63 2Eribulin

    64 1Escitalopram Oxalate

    65 1Eslicarbazepine Acetate

    66 4Esomeprazole Magnesium

    67 1Eszopiclone

    68 1Everolimus

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    70 1Famotidine

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    73 2Fexofenadine Hydrochloride

    74 1Finasteride

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    78 1Fosaprepitant

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    80 1Galantamine Hydrobromide

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    82 3Gemcitabine

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    84 1Glimepiride

    85 1Granisetron

    86 1Hydroxychloroquine Sulphate

    87 2Ibandronate Sodium

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    89 1Imatinib Mesylate

    90 1Iptacopan Hydrochloride

    91 1Irbesartan

    92 1Iron Sucrose

    93 9Ketorolac Trometamol

    94 1Lacidipine

    95 3Lenalidomide

    96 2Lenvatinib Mesylate

    97 1Letrozole

    98 1Levetiracetam

    99 1Levocetirizine Dihydrochloride

    100 1Levofloxacin Hemihydrate

    101 1Lifitegrast

    102 1Linagliptin

    103 1Linezolid

    104 1Liraglutide

    105 1Lomustine

    106 2Losartan Potassium

    107 1Lubiprostone

    108 1Lumateperone Tosylate

    109 1Lurasidone Hydrochloride

    110 1Memantine Hydrochloride

    111 2Metoprolol Succinate

    112 2Midostaurin

    113 1Milnacipran Hydrochloride

    114 2Mirabegron

    115 1Montelukast Sodium

    116 3Moxifloxacin Hydrochloride

    117 3Naproxen

    118 3Naproxen Sodium

    119 1Naratriptan Hydrochloride

    120 1Nateglinide

    121 1Nicotinamide Riboside Chloride

    122 3Nilotinib

    123 10Nizatidine

    124 1Olanzapine

    125 1Olaparib

    126 4Omeprazole

    127 2Omeprazole Magnesium

    128 1Ondansetron

    129 2Ondansetron Hydrochloride

    130 1Orforglipron Calcium Hydrate

    131 1Oxaprozin

    132 1Palbociclib

    133 1Paliperidone

    134 1Paliperidone Palmitate

    135 1Palonosetron

    136 4Pantoprazole Sodium

    137 1Pazopanib Hydrochloride

    138 2Pemetrexed Disodium

    139 1Pemetrexed Ditromethamine

    140 1Perfluorohexyloctane

    141 1Permethrin

    142 1Pioglitazone

    143 1Pioglitazone Hydrochloride

    144 1Pirtobrutinib

    145 1Plerixafor

    146 1Pomalidomide

    147 1Posaconazole

    148 1Prasugrel Hydrochloride

    149 5Pregabalin

    150 1Primidone

    151 1Quetiapine Hemifumarate

    152 3Rabeprazole Sodium

    153 1Raloxifene Hydrochloride

    154 1Ramipril

    155 1Relugolix

    156 1Resmetirom

    157 1Ripretinib

    158 2Risperidone

    159 2Rivaroxaban

    160 2Rivastigmine Tartrate

    161 1Ropinirole

    162 1Ropinirole Hydrochloride

    163 2Roxadustat

    164 2Sacubitril-Valsartan

    165 1Saxagliptin Hydrochloride

    166 1Seladelpar Lysine

    167 1Semaglutide

    168 1Siponimod

    169 1Siponimod fumarate

    170 2Sitagliptin Hydrochloride

    171 1Sitagliptin Malate

    172 3Sitagliptin Phosphate

    173 2Sugammadex Sodium

    174 2Sumatriptan

    175 1Tafamidis

    176 3Terbinafine Hydrochloride

    177 1Testosterone

    178 1Ticagrelor

    179 2Tizanidine Hydrochloride

    180 1Tofacitinib Citrate

    181 1Tolterodine Tartrate

    182 1Topiramate

    183 1Travoprost

    184 1Treprostinil Sodium

    185 3Tucatinib

    186 1Udenafil

    187 1Upadacitinib

    188 2Valganciclovir Hydrochloride

    189 3Valsartan

    190 1Varenicline Tartrate

    191 1Venetoclax

    192 1Venlafaxine Hydrochloride

    193 1Vilazodone Hydrochloride

    194 1Voclosporin

    195 1Vonoprazan Fumarate

    196 1Voriconazole

    197 1Xanomeline

    198 1Zafirlukast

    199 2Ziprasidone Hydrochloride

    200 1Zoledronic Acid

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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

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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

     CEP/COS arrow-down
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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

    Address of the Firm :

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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

     CEP/COS arrow-down
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    Certificate Number : R0-CEP 2021-067 - Rev 00

    Issue Date : 2023-07-06

    Type : Chemical

    Substance Number : 2280

    Status : Valid

     JDMF arrow-down
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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 :

    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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    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

     CEP/COS arrow-down
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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

     JDMF arrow-down
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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

    Address of the Firm :

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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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    DMF Review : N/A

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    DMF Number : 16747

    Submission : 2003-08-04

    Status : Active

    Type : II

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    Certificate Number : R1-CEP 2016-210 - Rev 00

    Issue Date : 2023-04-25

    Type : Chemical

    Substance Number : 2331

    Status : Valid

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    Registration Number : 303MF10057

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

    Initial Date of Registration : 2021-04-02

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    Date of Issue : 2025-05-28

    Valid Till : 2028-06-25

    Written Confirmation Number : WC-0035

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    NDC Package Code : 55111-055

    Start Marketing Date : 2010-01-30

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    Certificate Number : R1-CEP 2009-243 - Rev 03

    Issue Date : 2023-07-17

    Type : Chemical

    Substance Number : 1559

    Status : Valid

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    Registration Number : 218MF10413

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

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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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