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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 1Atomoxetin Hydrochloride

    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 1Cabazitaxel

    51 1Cabergoline

    52 2Calcipotriol

    53 1Calcitriol

    54 1Cantharidin

    55 1Capivasertib

    56 1Capmatinib

    57 2Carbidopa

    58 1Carboplatin

    59 1Carfilzomib

    60 1Carvedilol

    61 1Carvedilol Phosphate

    62 2Caspofungin

    63 1Cilostazol

    64 1Cinacalcet Hydrochloride

    65 1Cisatracurium Besylate

    66 1Cisplatin

    67 1Clascoterone

    68 1Clobetasol Propionate

    69 2Clopidogrel

    70 1Crisaborole

    71 4Cyclosporine

    72 1Cyproterone Acetate

    73 2Dabigatran Etexilate Mesylate

    74 1Dabrafenib Mesylate

    75 1Daprodustat

    76 1Darolutamide

    77 2Dasatinib

    78 1Daunorubicin HCl

    79 1Deferasirox

    80 1Deferoxamine Mesylate

    81 1Desloratadine

    82 1Desmopressin Acetate

    83 1Desonide

    84 1Desvenlafaxine Fumarate

    85 2Desvenlafaxine Succinate

    86 1Deutetrabenazine

    87 1Dexamethasone

    88 1Dexrazoxane

    89 1Diazoxide

    90 1Diflorasone

    91 1Difluprednate

    92 1Dihydroergotamine Mesylate

    93 1Dihydroergotoxine Mesylate

    94 1Diltiazem Hydrochloride

    95 2Dimethyl Fumarate

    96 1Diroximel fumarate

    97 1Docetaxel

    98 1Docosanol

    99 1Donepezil

    100 1Dorzolamide Hydrochloride

    101 1Doxcercalciferol

    102 1Doxepin Hydrochloride

    103 1Doxorubicin Hydrochloride

    104 1Drospirenone

    105 1Edoxaban Tosylate

    106 1Elacestrant

    107 1Elagolix Sodium

    108 1Eletriptan Hydrobromide

    109 1Eltrombopag

    110 1Empagliflozin

    111 1Entrectinib

    112 1Enzalutamide

    113 2Epirubicin Hydrochloride

    114 1Eptifibatide

    115 1Erdafitinib

    116 1Ergometrine

    117 1Ergonovine Maleate

    118 2Ergotamine Tartrate

    119 1Erlotinib Hydrochloride

    120 2Eszopiclone

    121 1Etoposide

    122 1Etrasimod

    123 2Ezetimibe

    124 1Famciclovir

    125 1Febuxostat

    126 1Fedratinib

    127 1Ferric Carboxymaltose

    128 1Ferric Citrate

    129 1Fidaxomicin

    130 1Filgrastim

    131 1Finerenone

    132 1Fingolimod Hydrochloride

    133 1Fludarabine Phosphate

    134 1Fludrocortisone Acetate

    135 2Flunisolide

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    137 2Fluocinonide

    138 1Fluorometholone

    139 1Fluorometholone Acetate

    140 1Fluorouracil

    141 1Fluoxetine Hydrochloride

    142 1Fluticasone Furoate

    143 1Fluticasone Propionate

    144 1Fluvastatin Sodium

    145 1Formoterol Fumarate

    146 1Fulvestrant

    147 2Gemcitabine

    148 1Glasdegib

    149 1Glycerol Phenylbutyrate

    150 1Haloperidol

    151 1Haloperidol Decanoate

    152 2Hydrochlorothiazide

    153 1Ibrutinib

    154 1Icatibant Acetate

    155 1Idarubicin Hydrochloride

    156 2Imatinib Mesylate

    157 1Imipramine Hydrochloride

    158 3Irbesartan

    159 1Iron Sucrose

    160 1Ivosidenib

    161 1Ixazomib Citrate

    162 1Lamotrigine

    163 1Larotrectinib

    164 1Lemborexant

    165 1Lenalidomide

    166 1Letermovir

    167 1Letrozole

    168 1Levalbuterol Hydrochloride

    169 1Levofloxacin

    170 1Linaclotide

    171 1Loperamide Hydrochloride

    172 1Lorlatinib

    173 4Losartan Potassium

    174 1Lotilaner

    175 2Lovastatin

    176 1Lumateperone Tosylate

    177 1Lurasidone Hydrochloride

    178 1Macitentan

    179 1Mavacamten

    180 1Maxacalcitol

    181 2Medroxyprogesterone Acetate

    182 1Megestrol Acetate

    183 1Memantine Hydrochloride

    184 1Methyldopa

    185 2Methylergonovine

    186 1Methylergonovine Maleate

    187 1Metopimazine

    188 1Micafungin

    189 1Midostaurin

    190 1Migalastat

    191 1Mitomycin

    192 1Modafinil

    193 1Momelotinib

    194 2Mometasone Furoate

    195 2Montelukast Sodium

    196 2Mupirocin

    197 2Mupirocin Calcium

    198 1Mycophenolate Mofetil

    199 1Mycophenolate Sodium

    200 1Nabumetone

    201 1Neratinib

    202 2Nicergoline

    203 1Nifedipine

    204 2Nilotinib

    205 1Nintedanib Esylate

    206 1Niraparib Tosylate

    207 1Nirogacestat Hydrobromide

    208 1Nitrofurantoin

    209 2Nomegestrol Acetate

    210 1Nusinersen

    211 1Octreotide Acetate

    212 2Olanzapine

    213 2Olmesartan Medoxomil

    214 1Olodaterol Hydrochloride

    215 2Omeprazole

    216 1Ondansetron

    217 2Ondansetron Hydrochloride

    218 1Osimertinib Mesylate

    219 1Oxaliplatin

    220 4Paclitaxel

    221 1Pacritinib

    222 1Palbociclib

    223 1Paliperidone

    224 1Paliperidone Palmitate

    225 2Palonosetron

    226 1Paricalcitol

    227 1Pemetrexed

    228 2Pemetrexed Disodium

    229 1Perampanel

    230 1Pergolide Mesylate

    231 1Pioglitazone Hydrochloride

    232 1Pirtobrutinib

    233 1Ponesimod

    234 1Potassium Citrate

    235 1Pralatrexate

    236 1Prasterone

    237 1Prasugrel Hydrobromide

    238 1Prasugrel Hydrochloride

    239 2Pravastatin

    240 1Prednicarbate

    241 1Prednisolone

    242 2Pregabalin

    243 1Probenecid

    244 2Quetiapine Hemifumarate

    245 1Raloxifene Hydrochloride

    246 1Ramelteon

    247 1Relugolix

    248 1Ribociclib

    249 1Rilpivirine Hydrochloride

    250 1Rimegepant Sulfate

    251 1Ripretinib

    252 1Risdiplam

    253 1Risedronate Sodium

    254 1Risperidone

    255 1Ritlecitinib

    256 1Rivaroxaban

    257 1Rocuronium Bromide

    258 1Romidepsin

    259 1Rosiglitazone Maleate

    260 2Rosuvastatin Calcium

    261 1Rotigotine

    262 1Roxadustat

    263 1Rusfertide

    264 1Sacubitril-Valsartan

    265 1Salbutamol Sulphate

    266 1Samidorphan

    267 1Saxagliptin

    268 1Semaglutide

    269 1Sildenafil Citrate

    270 1Silver Sulfadiazine

    271 1Silymarin

    272 3Simvastatin

    273 2Sitagliptin Malate

    274 3Sitagliptin Phosphate

    275 2Sofosbuvir

    276 2Solifenacin Succinate

    277 1Sorafenib

    278 1Sotagliflozin

    279 1Sotorasib

    280 1Sparsentan

    281 1Sugammadex Sodium

    282 1Sunitinib

    283 2Tacrolimus

    284 1Tadalafil

    285 1Tafamidis

    286 1Tafamidis Meglumine

    287 1Tamoxifen Citrate

    288 1Tapinarof

    289 1Telotristat Etiprate

    290 2Terazosin HCl

    291 2Ticagrelor

    292 1Tigecycline

    293 1Timolol Maleate

    294 1Tiotropium Bromide

    295 1Tirzepatide

    296 1Tivozanib

    297 2Tobramycin

    298 1Tolterodine Tartrate

    299 1Torsemide

    300 1Trazodone Hydrochloride

    301 1Triamcinolone

    302 1Triamcinolone Acetonide

    303 1Triheptanoin

    304 1Trilaciclib

    305 1Tucatinib

    306 1Ulipristal Acetate

    307 1Umeclidinium Bromide

    308 1Upadacitinib

    309 1Valbenazine Tosylate

    310 1Vamorolone

    311 1Varenicline Tartrate

    312 1Venetoclax

    313 2Venlafaxine Hydrochloride

    314 1Vericiguat

    315 1Vilanterol Trifenatate

    316 1Vilazodone Hydrochloride

    317 1Voclosporin

    318 1Warfarin Sodium

    319 1Zavegepant HCl

    320 1Zoledronic Acid

    321 1Zolpidem Tartrate

    322 1Zuranolone

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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
    ✖

    Certificate Number : CEP 1997-077 - Rev 16

    Issue Date : 2025-07-09

    Type : Chemical

    Substance Number : 1004

    Status : Valid

     JDMF arrow-down
    ✖

    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

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    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 : 15894-0022

    Start Marketing Date : 2011-08-09

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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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

     VMF CA, ASMF arrow-down
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    02

    Losartan Potassium

    Israel

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    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

     JDMF arrow-down
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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 :

    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 : 15894-0028

    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 : Samoh 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

    Latest Date of Registration :

    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 : 15894-0004

    Start Marketing Date : 2019-08-19

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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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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    GDUFA

    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 2017-165 - Rev 02

    Issue Date : 2025-05-28

    Type : Chemical

    Substance Number : 2777

    Status : Valid

     JDMF arrow-down
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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

    Latest Date of Registration :

    EU-WCarrow-down
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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

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

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Samoh 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

     JDMF arrow-down
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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

    Latest Date of Registration :

    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 :

    NDC arrow-down
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    NDC Package Code : 15894-0033

    Start Marketing Date : 2019-01-23

    End Marketing Date : 2026-12-31

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

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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

     JDMF arrow-down
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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 :

    EU-WC NDC arrow-down
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    NDC Package Code : 84644-003

    Start Marketing Date : 2017-12-29

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    Available Reg. Filing : BR, CA
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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

     JDMF arrow-down
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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

    Latest Date of Registration :

    EU-WC NDC arrow-down
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    NDC Package Code : 84644-009

    Start Marketing Date : 2017-12-18

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    Available Reg. Filing : BR
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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 2002-052 - Rev 09

    Issue Date : 2025-02-25

    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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    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

    Israel

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    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

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    Registrant Name : Samoh Pharmaceutical Co., Ltd.

    Registration Date : 2019-08-27

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

    Manufacturer Name : Teva API India Private Limited (Malanpur site) @ [Intermediate 'Clopidogrel Camsylate' manufacturing plant] 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 Distt. Amroha (Uttar Pradesh), India

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