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    01 1Abaloparatide

    02 1Abemaciclib

    03 1Abiraterone Acetate

    04 1Abrocitinib

    05 1Acetic Acid

    06 1Adagrasib

    07 1Afatinib

    08 1Alclometasone Dipropionate

    09 1Alfacalcidol

    10 3Allopurinol

    11 1Alpelisib

    12 1Amcinonide

    13 1Amitriptyline Hydrochloride

    14 1Anastrozole

    15 1Apalutamide

    16 1Apixaban

    17 1Aripiprazole

    18 1Asciminib

    19 1Atomoxetine

    20 4Atorvastatin

    21 1Atosiban

    22 1Atracurium Besylate

    23 1Avacopan

    24 1Avapritinib

    25 1Azacitidine

    26 2Azithromycin

    27 1Azithromycin Dihydrate

    28 1Aztreonam

    29 1Baloxavir Marboxil

    30 1Baricitinib

    31 2Beclomethasone Dipropionate

    32 1Belumosudil

    33 1Belzutifan

    34 1Bempedoic Acid

    35 1Betamethasone

    36 1Betamethasone Acetate

    37 1Betamethasone Dipropionate

    38 1Betamethasone Valerate

    39 1Bicalutamide

    40 1Bivalirudin

    41 1Bleomycin Sulphate

    42 1Bortezomib

    43 1Brexanolone

    44 1Brexpiprazole

    45 1Bromocriptine Mesylate

    46 3Budesonide

    47 1Buprenorphine

    48 1Buprenorphine Hydrochloride

    49 1Butorphanol Tartrate

    50 1CAS 137281-39-1

    51 1Cabazitaxel

    52 1Cabergoline

    53 2Calcipotriol

    54 1Calcitriol

    55 1Cantharidin

    56 1Capivasertib

    57 1Capmatinib

    58 2Carbidopa

    59 1Carboplatin

    60 1Carfilzomib

    61 1Carvedilol

    62 1Carvedilol Phosphate

    63 2Caspofungin

    64 1Cilostazol

    65 1Cinacalcet Hydrochloride

    66 1Cisatracurium Besylate

    67 1Cisplatin

    68 1Clascoterone

    69 1Clobetasol Propionate

    70 2Clopidogrel

    71 1Crisaborole

    72 4Cyclosporine

    73 1Cyproterone Acetate

    74 2Dabigatran Etexilate Mesylate

    75 1Dabrafenib Mesylate

    76 1Daprodustat

    77 1Darolutamide

    78 2Dasatinib

    79 1Daunorubicin HCl

    80 1Deferasirox

    81 1Deferoxamine Mesylate

    82 1Desloratadine

    83 1Desmopressin Acetate

    84 1Desonide

    85 1Desvenlafaxine Fumarate

    86 2Desvenlafaxine Succinate

    87 1Deutetrabenazine

    88 1Dexamethasone

    89 1Dexrazoxane

    90 1Diazoxide

    91 1Diflorasone

    92 1Difluprednate

    93 1Dihydroergotamine Mesylate

    94 1Dihydroergotoxine Mesylate

    95 1Diltiazem Hydrochloride

    96 2Dimethyl Fumarate

    97 1Diroximel fumarate

    98 1Docetaxel

    99 1Docosanol

    100 1Donepezil

    101 1Dorzolamide Hydrochloride

    102 1Doxcercalciferol

    103 1Doxepin Hydrochloride

    104 1Doxorubicin Hydrochloride

    105 1Drospirenone

    106 1Edoxaban Tosylate

    107 1Elacestrant

    108 1Elagolix Sodium

    109 1Eletriptan Hydrobromide

    110 1Eltrombopag

    111 1Empagliflozin

    112 1Entrectinib

    113 1Enzalutamide

    114 2Epirubicin Hydrochloride

    115 1Eptifibatide

    116 1Erdafitinib

    117 1Ergometrine

    118 1Ergonovine Maleate

    119 2Ergotamine Tartrate

    120 1Erlotinib Hydrochloride

    121 2Eszopiclone

    122 1Etoposide

    123 1Etrasimod

    124 2Ezetimibe

    125 1Famciclovir

    126 1Febuxostat

    127 1Fedratinib

    128 1Ferric Carboxymaltose

    129 1Ferric Citrate

    130 1Fidaxomicin

    131 1Filgrastim

    132 1Finerenone

    133 1Fingolimod Hydrochloride

    134 1Fludarabine Phosphate

    135 1Fludrocortisone Acetate

    136 2Flunisolide

    137 2Fluocinolone Acetonide

    138 2Fluocinonide

    139 1Fluorometholone

    140 1Fluorometholone Acetate

    141 1Fluorouracil

    142 1Fluoxetine Hydrochloride

    143 1Fluticasone Furoate

    144 1Fluticasone Propionate

    145 1Fluvastatin Sodium

    146 1Formoterol Fumarate

    147 1Fulvestrant

    148 2Gemcitabine

    149 1Glasdegib

    150 1Glycerol Phenylbutyrate

    151 1Haloperidol

    152 1Haloperidol Decanoate

    153 2Hydrochlorothiazide

    154 1Ibrutinib

    155 1Icatibant Acetate

    156 1Idarubicin Hydrochloride

    157 2Imatinib Mesylate

    158 1Imipramine Hydrochloride

    159 3Irbesartan

    160 1Iron Sucrose

    161 1Ivosidenib

    162 1Ixazomib Citrate

    163 1Lamotrigine

    164 1Larotrectinib

    165 1Lemborexant

    166 1Lenalidomide

    167 1Letermovir

    168 1Letrozole

    169 1Levalbuterol Hydrochloride

    170 1Levofloxacin

    171 1Linaclotide

    172 1Loperamide Hydrochloride

    173 1Lorlatinib

    174 4Losartan Potassium

    175 1Lotilaner

    176 2Lovastatin

    177 1Lumateperone Tosylate

    178 1Lurasidone Hydrochloride

    179 1Macitentan

    180 1Mavacamten

    181 1Maxacalcitol

    182 2Medroxyprogesterone Acetate

    183 1Megestrol Acetate

    184 1Memantine Hydrochloride

    185 1Methyldopa

    186 2Methylergonovine

    187 1Methylergonovine Maleate

    188 1Metopimazine

    189 1Micafungin

    190 1Midostaurin

    191 1Migalastat

    192 1Mitomycin

    193 1Modafinil

    194 1Momelotinib

    195 2Mometasone Furoate

    196 2Montelukast Sodium

    197 2Mupirocin

    198 2Mupirocin Calcium

    199 1Mycophenolate Mofetil

    200 1Mycophenolate Sodium

    201 1Nabumetone

    202 1Neratinib

    203 2Nicergoline

    204 1Nifedipine

    205 2Nilotinib

    206 1Nintedanib Esylate

    207 1Niraparib Tosylate

    208 1Nirogacestat Hydrobromide

    209 1Nitrofurantoin

    210 2Nomegestrol Acetate

    211 1Nusinersen

    212 1Octreotide Acetate

    213 2Olanzapine

    214 2Olmesartan Medoxomil

    215 1Olodaterol Hydrochloride

    216 2Omeprazole

    217 1Ondansetron

    218 2Ondansetron Hydrochloride

    219 1Osimertinib Mesylate

    220 1Oxaliplatin

    221 4Paclitaxel

    222 1Pacritinib

    223 1Palbociclib

    224 1Paliperidone

    225 1Paliperidone Palmitate

    226 2Palonosetron

    227 1Paricalcitol

    228 1Pemetrexed

    229 2Pemetrexed Disodium

    230 1Perampanel

    231 1Pergolide Mesylate

    232 1Pioglitazone Hydrochloride

    233 1Pirtobrutinib

    234 1Ponesimod

    235 1Potassium Citrate

    236 1Pralatrexate

    237 1Prasterone

    238 1Prasugrel Hydrobromide

    239 1Prasugrel Hydrochloride

    240 2Pravastatin

    241 1Prednicarbate

    242 1Prednisolone

    243 2Pregabalin

    244 1Probenecid

    245 2Quetiapine Hemifumarate

    246 1Raloxifene Hydrochloride

    247 1Ramelteon

    248 1Relugolix

    249 1Ribociclib

    250 1Rilpivirine Hydrochloride

    251 1Rimegepant Sulfate

    252 1Ripretinib

    253 1Risdiplam

    254 1Risedronate Sodium

    255 1Risperidone

    256 1Ritlecitinib

    257 1Rivaroxaban

    258 1Rocuronium Bromide

    259 1Romidepsin

    260 1Rosiglitazone Maleate

    261 2Rosuvastatin Calcium

    262 1Rotigotine

    263 1Roxadustat

    264 1Rusfertide

    265 1Sacubitril-Valsartan

    266 1Salbutamol Sulphate

    267 1Samidorphan

    268 1Saxagliptin

    269 1Semaglutide

    270 1Sildenafil Citrate

    271 1Silver Sulfadiazine

    272 1Silymarin

    273 3Simvastatin

    274 2Sitagliptin Malate

    275 3Sitagliptin Phosphate

    276 2Sofosbuvir

    277 2Solifenacin Succinate

    278 1Sorafenib

    279 1Sotagliflozin

    280 1Sotorasib

    281 1Sparsentan

    282 1Sugammadex Sodium

    283 1Sunitinib

    284 2Tacrolimus

    285 1Tadalafil

    286 1Tafamidis

    287 1Tafamidis Meglumine

    288 1Tamoxifen Citrate

    289 1Tapinarof

    290 1Telotristat Etiprate

    291 2Terazosin HCl

    292 2Ticagrelor

    293 1Tigecycline

    294 1Timolol Maleate

    295 1Tiotropium Bromide

    296 1Tirzepatide

    297 1Tivozanib

    298 2Tobramycin

    299 1Tolterodine Tartrate

    300 1Torsemide

    301 1Trazodone Hydrochloride

    302 1Triamcinolone

    303 1Triamcinolone Acetonide

    304 1Triheptanoin

    305 1Trilaciclib

    306 1Tucatinib

    307 1Ulipristal Acetate

    308 1Umeclidinium Bromide

    309 1Upadacitinib

    310 1Valbenazine Tosylate

    311 1Vamorolone

    312 1Varenicline Tartrate

    313 1Venetoclax

    314 2Venlafaxine Hydrochloride

    315 1Vericiguat

    316 1Vilanterol Trifenatate

    317 1Vilazodone Hydrochloride

    318 1Voclosporin

    319 1Warfarin Sodium

    320 1Zavegepant HCl

    321 1Zoledronic Acid

    322 1Zolpidem Tartrate

    323 1Zuranolone

    324 1Blank

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    01

    Diltiazem Hydrochloride

    Israel

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-29

    Pay. Date : 2012-11-08

    DMF Number : 7239

    Submission : 1987-11-30

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 1997-077 - Rev 16

    Issue Date : 2025-07-09

    Type : Chemical

    Substance Number : 1004

    Status : Valid

     JDMF arrow-down
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    Registration Number : 225MF10001

    Registrant's Address : Plot No. 2G, 2H, 2I, Udyog Vihar, Greater Noida-201 308 (U.P.) India

    Initial Date of Registration : 2013-01-15

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    Date of Issue : 2025-04-24

    Valid Till : 2028-05-25

    Written Confirmation Number : WC-0002

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    NDC Package Code : 15894-0022

    Start Marketing Date : 2011-08-09

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Korea Unipharm Co., Ltd.

    Registration Date : 2020-03-02

    Registration Number : 20200302-209-J-279

    Manufacturer Name : Teva API India Private Limited

    Manufacturer Address : Plot Nos. A-2, A-2/1, A-2/2, UPSIDC Industrial Area, Bijnor Road, Gajraula-244 235, Distt. Amroha (Uttar Pradesh) India

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    02

    Losartan Potassium

    Israel

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    DMF Review : N/A

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    DMF Number : 16996

    Submission : 2003-12-03

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2009-332 - Rev 05

    Issue Date : 2025-07-16

    Type : Chemical

    Substance Number : 2232

    Status : Valid

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    Registration Number : 230MF10060

    Registrant's Address : Plot No. 2G, 2H, 2I, Udyog Vihar, Greater Noida-201 308 (U.P.) India

    Initial Date of Registration : 2018-05-08

    Latest Date of Registration :

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    Date of Issue : 2025-06-04

    Valid Till : 2028-05-20

    Written Confirmation Number : WC-0001

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    NDC Package Code : 15894-0028

    Start Marketing Date : 2015-12-14

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (100kg/100kg)

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Sam-O Pharmaceutical Co., Ltd.

    Registration Date : 2013-03-07

    Registration Number : 20130307-122-G-116-35

    Manufacturer Name : Teva API India Pvt. Ltd

    Manufacturer Address : Plot No. Q1 ~ Q4, Industrial Area, Ghirogi, Malanpur Distt. Bhind (Madhya Pradesh)-477117 India

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    03

    Montelukast Sodium

    Israel

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19829

    Submission : 2006-10-04

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2017-131 - Rev 06

    Issue Date : 2025-03-12

    Type : Chemical

    Substance Number : 2583

    Status : Valid

     JDMF arrow-down
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    Registration Number : 305MF10076

    Registrant's Address : Plot No. 2G, 2H, 2I, Udyog Vihar, Greater Noida - 201 308 (U.P.) India

    Initial Date of Registration : 2023-07-05

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    EU-WCarrow-down
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    Date of Issue : 2025-04-24

    Valid Till : 2028-05-25

    Written Confirmation Number : WC-0002

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    NDC Package Code : 15894-0004

    Start Marketing Date : 2019-08-19

    End Marketing Date : 2026-12-31

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    Registrant Name : Korea Pharmaceutical Co., Ltd.

    Registration Date : 2019-03-06

    Registration Number : 20180208-209-J-62(1)

    Manufacturer Name : Teva API India Private Limited Gajraula site

    Manufacturer Address : Plot No. A-2, A-2/1, A-2/2, UPSIDC Industrial Area, Bijnor Road, Gajraula-244 235, Distt. Amroha (UP) India

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    04

    Pregabalin

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    DMF Review : Reviewed

    Rev. Date : 2012-11-23

    Pay. Date : 2012-11-13

    DMF Number : 22242

    Submission : 2008-12-01

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2020-375 - Rev 03

    Issue Date : 2025-03-14

    Type : Chemical

    Substance Number : 2777

    Status : Valid

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    Registration Number : 230MF10103

    Registrant's Address : Plot No. 2G, 2H, 2I, Udyog Vihar, Greater Noida-201 308 (U.P.) India

    Initial Date of Registration : 2018-08-08

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    Date of Issue : 2025-04-24

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    Written Confirmation Number : WC-0002

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    NDC Package Code : 15894-0016

    Start Marketing Date : 2019-03-26

    End Marketing Date : 2026-12-31

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    Registrant Name : Sam-O Pharmaceutical Co., Ltd.

    Registration Date : 2015-12-02

    Registration Number : Su2991-23-ND

    Manufacturer Name : Teva API India Private Limited

    Manufacturer Address : Plot No. A-2, A-2/1, A-2/2, UPSIDC Industrial Area, Gajraula, Distt. JP Nagar (UP) India

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    05

    Amitriptyline Hydrochloride

    Israel

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    Certificate Number : CEP 2001-432 - Rev 07

    Issue Date : 2026-02-23

    Type : Chemical

    Substance Number : 464

    Status : Valid

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    Registration Number : 302MF10137

    Registrant's Address : Plot No. 2G, 2H, 2I, Udyog Vihar, Greater Noida-201 308 (U.P.) India

    Initial Date of Registration : 2020-11-26

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    EU-WCarrow-down
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    Date of Issue : 2025-06-04

    Valid Till : 2028-05-20

    Written Confirmation Number : WC-0001

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    NDC Package Code : 15894-0033

    Start Marketing Date : 2019-01-23

    End Marketing Date : 2026-12-31

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    06

    Bromocriptine Mesylate

    Israel

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-30

    Pay. Date : 2012-11-13

    DMF Number : 14768

    Submission : 2000-03-03

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2006-281 - Rev 04

    Issue Date : 2025-03-19

    Type : Chemical

    Substance Number : 596

    Status : Valid

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    Registration Number : 218MF10573

    Registrant's Address : Ostravska 305/29, Komarov, 747 70 Opava, Czech Republic

    Initial Date of Registration : 2006-06-15

    Latest Date of Registration :

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    NDC Package Code : 84644-003

    Start Marketing Date : 2017-12-29

    End Marketing Date : 2026-12-31

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    07

    Cabergoline

    Israel

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-02

    Pay. Date : 2012-11-13

    DMF Number : 18113

    Submission : 2005-02-21

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2006-170 - Rev 05

    Issue Date : 2024-12-17

    Type : Chemical

    Substance Number : 1773

    Status : Valid

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    Registration Number : 217MF11279

    Registrant's Address : Ostravska 305/29, Komarov, 747 70 Opava, Czech Republic

    Initial Date of Registration : 2005-12-20

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    NDC Package Code : 84644-009

    Start Marketing Date : 2017-12-18

    End Marketing Date : 2026-12-31

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    08

    Carbidopa

    Israel

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-29

    Pay. Date : 2012-11-13

    DMF Number : 8296

    Submission : 1989-11-14

    Status : Active

    Type : II

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    Certificate Number : CEP 2001-352 - Rev 09

    Issue Date : 2025-07-03

    Type : Chemical

    Substance Number : 755

    Status : Valid

     JDMF EU-WCarrow-down
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    Date of Issue : 2025-04-24

    Valid Till : 2028-05-25

    Written Confirmation Number : WC-0002

    Address of the Firm :

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    NDC Package Code : 15894-0040

    Start Marketing Date : 2023-02-23

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    Available Reg. Filing : CA, ASMF
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    Caspofungin

    Israel

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-04-14

    Pay. Date : 2013-03-20

    DMF Number : 26978

    Submission : 2013-06-21

    Status : Active

    Type : II

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    Registration Number : 305MF10081

    Registrant's Address : Plot No. 2G, 2H, 2I, Udyog Vihar, Greater Noida-201 308 (U.P.) India

    Initial Date of Registration : 2023-07-12

    Latest Date of Registration :

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    Date of Issue : 2025-04-24

    Valid Till : 2028-05-25

    Written Confirmation Number : WC-0002

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    NDC Package Code : 15894-0014

    Start Marketing Date : 2017-11-17

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (100kg/100kg)

    Marketing Category : BULK INGREDIENT

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    Registrant Name : MSD Korea Co., Ltd.

    Registration Date : 2025-07-01

    Registration Number : 20210317-210-J-758(1)

    Manufacturer Name : Teva API India Private Limited

    Manufacturer Address : Plot No.: A-2, A-2/1, A-2/2, UPSIDC Industrial Area, Bijnor Road, Gajraula-244 235, Distt. Amroha (UP), INDIA

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    Clopidogrel

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-29

    Pay. Date : 2012-11-13

    DMF Number : 17009

    Submission : 2003-12-05

    Status : Active

    Type : II

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    Certificate Number : CEP 2017-260 - Rev 01

    Issue Date : 2025-03-11

    Type : Chemical

    Substance Number : 2531

    Status : Valid

     JDMF EU-WCarrow-down
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    Date of Issue : 2025-06-04

    Valid Till : 2028-05-20

    Written Confirmation Number : WC-0001

    Address of the Firm :

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    Registrant Name : Sam-O Pharmaceutical Co., Ltd.

    Registration Date : 2019-08-27

    Registration Number : 20190827-129-H-348-45

    Manufacturer Name : Teva API India Private Limited (Malanpur site)@[Manufacturer of intermediate 'clopidogrel camsylate']Teva API India Private Limited (Gajraula site)

    Manufacturer Address : Plot Nos. Q1 to Q4 Industrial Area, Ghirongi, Malanpur, District-Bhind (Madhya Pradesh), India @ [Manufacturing Plant for Intermediate 'Clopidogrel Camsylate'] Plot Nos. A-2, A-2/1, A-2/2, UPSIDC Industrial Area, Gajraula District, Amroha (Uttar Pradesh), India

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