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    01 1Abaloparatide

    02 1Abemaciclib

    03 1Abiraterone Acetate

    04 1Abrocitinib

    05 1Acetic Acid

    06 1Acyclovir

    07 1Adagrasib

    08 1Afatinib

    09 1Alclometasone Dipropionate

    10 1Alendronate Sodium

    11 1Alfacalcidol

    12 3Allopurinol

    13 1Alpelisib

    14 1Amcinonide

    15 1Amitriptyline Hydrochloride

    16 1Anastrozole

    17 1Apalutamide

    18 1Apixaban

    19 1Aripiprazole

    20 1Asciminib

    21 2Atenolol

    22 1Atomoxetin Hydrochloride

    23 4Atorvastatin

    24 1Atosiban

    25 1Atracurium Besylate

    26 1Avacopan

    27 1Avapritinib

    28 1Azacitidine

    29 3Azithromycin

    30 1Azithromycin Dihydrate

    31 2Aztreonam

    32 1Baloxavir Marboxil

    33 1Baricitinib

    34 3Beclomethasone Dipropionate

    35 1Belumosudil

    36 1Belzutifan

    37 1Bempedoic Acid

    38 1Betamethasone

    39 1Betamethasone Acetate

    40 1Betamethasone Dipropionate

    41 1Betamethasone Valerate

    42 1Bicalutamide

    43 1Bivalirudin

    44 1Bleomycin Sulphate

    45 1Bortezomib

    46 1Brexanolone

    47 1Brexpiprazole

    48 1Bromocriptine Mesylate

    49 3Budesonide

    50 1Buprenorphine

    51 1Buprenorphine Hydrochloride

    52 1Butorphanol Tartrate

    53 1CAS 137281-39-1

    54 1Cabazitaxel

    55 1Cabergoline

    56 2Calcipotriol

    57 1Calcitriol

    58 1Candesartan Cilexetil

    59 1Cantharidin

    60 1Capecitabine

    61 1Capivasertib

    62 1Capmatinib

    63 2Carbamazepine

    64 2Carbidopa

    65 1Carboplatin

    66 1Carfilzomib

    67 1Carvedilol

    68 1Carvedilol Phosphate

    69 2Caspofungin

    70 1Cefaclor

    71 1Cefadroxil

    72 1Cefazolin Sodium

    73 1Cefdinir

    74 1Cefprozil

    75 1Cephalexin

    76 1Cephalexin Monohydrate

    77 1Cephalosporin

    78 1Cephradine

    79 1Chlorthalidone

    80 1Choline Fenofibrate

    81 1Cilostazol

    82 1Cinacalcet Hydrochloride

    83 1Cisatracurium Besylate

    84 1Cisplatin

    85 1Clarithromycin

    86 1Clascoterone

    87 2Clobetasol Propionate

    88 1Clomiphene Citrate

    89 2Clopidogrel

    90 1Cloxacillin Sodium

    91 3Conjugated Estrogens

    92 1Crisaborole

    93 1Cyclacillin

    94 4Cyclosporine

    95 1Cyproterone Acetate

    96 2Dabigatran Etexilate Mesylate

    97 1Dabrafenib Mesylate

    98 1Daprodustat

    99 1Darifenacin Hydrobromide

    100 1Darolutamide

    101 2Dasatinib

    102 1Daunorubicin HCl

    103 1Deferasirox

    104 1Deferoxamine Mesylate

    105 1Desfesoterodine

    106 1Desloratadine

    107 1Desmopressin Acetate

    108 1Desonide

    109 1Desvenlafaxine Fumarate

    110 3Desvenlafaxine Succinate

    111 1Deutetrabenazine

    112 1Dexamethasone

    113 1Dexrazoxane

    114 1Diazoxide

    115 1Diflorasone

    116 1Difluprednate

    117 1Dihydroergocristine

    118 1Dihydroergotamine Mesylate

    119 1Dihydroergotoxine Mesylate

    120 1Diltiazem Hydrochloride

    121 2Dimethyl Fumarate

    122 1Diroximel fumarate

    123 1Disodium Pamidronate Pentahydrate

    124 1Docetaxel

    125 1Docosanol

    126 1Donepezil

    127 1Dorzolamide Hydrochloride

    128 1Doxcercalciferol

    129 1Doxepin Hydrochloride

    130 1Doxorubicin Hydrochloride

    131 1Drospirenone

    132 1Duloxetine Hydrochloride

    133 1Edoxaban Tosylate

    134 1Elacestrant

    135 1Elagolix Sodium

    136 1Eletriptan Hydrobromide

    137 1Eltrombopag

    138 1Empagliflozin

    139 1Entrectinib

    140 1Enzalutamide

    141 2Epirubicin Hydrochloride

    142 1Eptifibatide

    143 1Erdafitinib

    144 1Ergometrine

    145 1Ergonovine Maleate

    146 2Ergotamine Tartrate

    147 1Erlotinib Hydrochloride

    148 2Eszopiclone

    149 1Etodolac

    150 2Etoposide

    151 1Etrasimod

    152 1Exenatide

    153 2Ezetimibe

    154 1Famciclovir

    155 1Febuxostat

    156 1Fedratinib

    157 1Ferric Carboxymaltose

    158 1Ferric Citrate

    159 2Fexofenadine Hydrochloride

    160 1Fidaxomicin

    161 1Filgrastim

    162 1Finerenone

    163 1Fingolimod Hydrochloride

    164 1Fludarabine Phosphate

    165 1Fludrocortisone Acetate

    166 2Flunisolide

    167 2Fluocinolone Acetonide

    168 2Fluocinonide

    169 1Fluorometholone

    170 1Fluorometholone Acetate

    171 1Fluorouracil

    172 1Fluoxetine Hydrochloride

    173 1Fluticasone Furoate

    174 1Fluticasone Propionate

    175 1Fluvastatin Sodium

    176 1Fluvoxamine

    177 1Formoterol Fumarate

    178 1Fosamprenavir

    179 2Fulvestrant

    180 1Furosemide

    181 2Gabapentin

    182 1Galantamine Hydrobromide

    183 1Gatifloxacin

    184 2Gemcitabine

    185 1Gemfibrozil

    186 1Glasdegib

    187 1Glatiramer Acetate

    188 1Glycerol Phenylbutyrate

    189 1Halobetasol

    190 1Haloperidol

    191 1Haloperidol Decanoate

    192 2Hydrochlorothiazide

    193 1Hydrocortisone Butyrate

    194 1Ibandronate Sodium

    195 1Ibrutinib

    196 1Icatibant Acetate

    197 1Idarubicin Hydrochloride

    198 2Imatinib Mesylate

    199 1Imipramine Hydrochloride

    200 1Imiquimod

    201 4Irbesartan

    202 1Iron Sucrose

    203 1Ivosidenib

    204 1Ixazomib Citrate

    205 2Labetalol Hydrochloride

    206 1Lacosamide

    207 1Lamotrigine

    208 1Lansoprazole

    209 1Larotrectinib

    210 1Latanoprost

    211 1Lemborexant

    212 1Lenalidomide

    213 1Letermovir

    214 1Letrozole

    215 1Leuprolide Acetate

    216 1Levalbuterol Hydrochloride

    217 1Levetiracetam

    218 1Levodopa

    219 1Levofloxacin

    220 1Linaclotide

    221 1Linagliptin

    222 1Linezolid

    223 1Lisinopril

    224 1Lisuride

    225 1Lisuride Maleate

    226 1Loperamide Hydrochloride

    227 1Lorazepam

    228 1Lorlatinib

    229 4Losartan Potassium

    230 1Lotilaner

    231 2Lovastatin

    232 1Lr-103

    233 1Lubiprostone

    234 1Lumateperone Tosylate

    235 1Lurasidone Hydrochloride

    236 1Macitentan

    237 1Mavacamten

    238 1Maxacalcitol

    239 2Medroxyprogesterone Acetate

    240 1Megestrol Acetate

    241 1Memantine Hydrochloride

    242 1Mesalazine

    243 1Metformin

    244 2Methyldopa

    245 2Methylergonovine

    246 1Methylergonovine Maleate

    247 1Metopimazine

    248 1Metoprolol Succinate

    249 2Metoprolol Tartrate

    250 1Micafungin

    251 1Midostaurin

    252 1Migalastat

    253 1Milk Thistle Extract

    254 1Mirtazapine

    255 2Misoprostol

    256 1Mitomycin

    257 1Mitoxantrone

    258 2Modafinil

    259 1Momelotinib

    260 2Mometasone Furoate

    261 2Montelukast Sodium

    262 2Mupirocin

    263 2Mupirocin Calcium

    264 1Mycophenolate Mofetil

    265 1Mycophenolate Sodium

    266 1Nabumetone

    267 2Naproxen

    268 1Nateglinide

    269 1Nefazodone Hydrochloride

    270 1Neratinib

    271 2Nicergoline

    272 1Nifedipine

    273 2Nilotinib

    274 1Nintedanib Esylate

    275 1Niraparib Tosylate

    276 1Nirogacestat Hydrobromide

    277 1Nitrofurantoin

    278 2Nomegestrol Acetate

    279 1Norgestimate

    280 1Nusinersen

    281 1Octreotide Acetate

    282 2Olanzapine

    283 2Olmesartan Medoxomil

    284 1Olodaterol Hydrochloride

    285 2Omeprazole

    286 1Ondansetron

    287 2Ondansetron Hydrochloride

    288 1Osimertinib Mesylate

    289 1Oxacillin Sodium

    290 1Oxaliplatin

    291 1Oxazepam

    292 4Paclitaxel

    293 1Pacritinib

    294 1Palbociclib

    295 1Paliperidone

    296 1Paliperidone Palmitate

    297 2Palonosetron

    298 1Pancuronium Bromide

    299 2Pantoprazole Sodium

    300 1Paricalcitol

    301 1Paroxetine Hydrochloride

    302 1Pemetrexed

    303 2Pemetrexed Disodium

    304 1Penicillin G Sulfoxide

    305 1Penicillin V Potassium

    306 1Pentoxifylline

    307 1Perampanel

    308 1Pergolide Mesylate

    309 1Pioglitazone Hydrochloride

    310 1Pirtobrutinib

    311 1Ponesimod

    312 1Potassium Citrate

    313 1Pralatrexate

    314 1Prasterone

    315 1Prasugrel Hydrobromide

    316 1Prasugrel Hydrochloride

    317 2Pravastatin

    318 1Prednicarbate

    319 1Prednisolone

    320 2Pregabalin

    321 1Probenecid

    322 2Quetiapine Hemifumarate

    323 2Raloxifene Hydrochloride

    324 1Ramelteon

    325 1Rasagiline Mesylate

    326 1Relugolix

    327 1Ribociclib

    328 1Rilpivirine Hydrochloride

    329 1Rimegepant Sulfate

    330 1Ripretinib

    331 1Risdiplam

    332 1Risedronate Sodium

    333 1Risperidone

    334 1Ritlecitinib

    335 1Rivaroxaban

    336 1Rocuronium Bromide

    337 1Romidepsin

    338 1Rosiglitazone Maleate

    339 3Rosuvastatin Calcium

    340 1Rotigotine

    341 1Roxadustat

    342 1Rusfertide

    343 1Sacubitril-Valsartan

    344 1Salbutamol Sulphate

    345 1Samidorphan

    346 1Saxagliptin

    347 1Selegiline Hydrochloride

    348 1Semaglutide

    349 1Sertraline Hydrochloride

    350 1Sildenafil Citrate

    351 1Silver Sulfadiazine

    352 1Silymarin

    353 4Simvastatin

    354 2Sitagliptin Malate

    355 3Sitagliptin Phosphate

    356 1Sodium Dicloxacillin

    357 2Sofosbuvir

    358 2Solifenacin Succinate

    359 1Sorafenib

    360 1Sotagliflozin

    361 1Sotorasib

    362 1Sparsentan

    363 1Sugammadex Sodium

    364 2Sulfamethoxazole

    365 1Sunitinib

    366 2Tacrolimus

    367 1Tadalafil

    368 1Tafamidis

    369 1Tafamidis Meglumine

    370 1Tamoxifen Citrate

    371 1Tapinarof

    372 1Telmisartan

    373 1Telotristat Etiprate

    374 3Terazosin HCl

    375 1Terbinafine Hydrochloride

    376 1Terfenadine

    377 1Terguride hydrogen maleate

    378 1Teriparatide Acetate

    379 1Thiotepa

    380 2Ticagrelor

    381 1Ticlopidine

    382 1Tigecycline

    383 1Timolol Maleate

    384 1Tiotropium Bromide

    385 1Tirzepatide

    386 1Tivozanib

    387 2Tobramycin

    388 1Tolterodine Tartrate

    389 2Torsemide

    390 2Trazodone Hydrochloride

    391 1Triamcinolone

    392 2Triamcinolone Acetonide

    393 1Triheptanoin

    394 1Trilaciclib

    395 1Trimethoprim

    396 1Trimipramine

    397 1Tucatinib

    398 1Ulipristal Acetate

    399 1Umeclidinium Bromide

    400 1Upadacitinib

    401 1Valacyclovir Hydrochloride

    402 1Valbenazine Tosylate

    403 1Valrubicin

    404 1Vamorolone

    405 1Varenicline Tartrate

    406 1Vecuronium Bromide

    407 1Venetoclax

    408 2Venlafaxine Hydrochloride

    409 1Verapamil Hydrochloride

    410 1Vericiguat

    411 1Vilanterol Trifenatate

    412 1Vilazodone Hydrochloride

    413 1Voclosporin

    414 1Warfarin Sodium

    415 1Zaleplon

    416 1Zavegepant HCl

    417 1Zoledronate Disodium

    418 1Zoledronic Acid

    419 1Zolmitriptan

    420 2Zolpidem Tartrate

    421 1Zonisamide

    422 1Zuranolone

    423 4Blank

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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

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    Certificate Number : CEP 1997-077 - Rev 16

    Issue Date : 2025-07-09

    Type : Chemical

    Substance Number : 1004

    Status : Valid

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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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    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

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    Certificate Number : CEP 2021-227 - Rev 02

    Issue Date : 2025-03-12

    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

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    Date of Issue : 2025-06-04

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    NDC Package Code : 15894-0028

    Start Marketing Date : 2015-12-14

    End Marketing Date : 2026-12-31

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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

    Methyldopa

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    DMF Review : Reviewed

    Rev. Date : 2014-05-07

    Pay. Date : 2012-12-20

    DMF Number : 26726

    Submission : 2013-01-24

    Status : Active

    Type : II

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    Certificate Number : CEP 2010-326 - Rev 06

    Issue Date : 2025-03-14

    Type : Chemical

    Substance Number : 45

    Status : Valid

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    Registration Number : 227MF10141

    Registrant's Address : No. 1889, Jingliu Road, Linjiang Industrial Zone, Qiantang New District, Hangzhou, China

    Initial Date of Registration : 2015-05-14

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    Date of Issue : 2025-04-24

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    NDC Package Code : 15894-0038

    Start Marketing Date : 2022-01-24

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    04

    Montelukast Sodium

    Israel

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    DMF Review : N/A

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    DMF Number : 19829

    Submission : 2006-10-04

    Status : Active

    Type : II

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    Certificate Number : CEP 2017-131 - Rev 06

    Issue Date : 2025-03-12

    Type : Chemical

    Substance Number : 2583

    Status : Valid

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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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    Date of Issue : 2025-04-24

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    NDC Package Code : 15894-0004

    Start Marketing Date : 2019-08-19

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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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    05

    Pregabalin

    Israel

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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 2017-165 - Rev 02

    Issue Date : 2025-05-28

    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

    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

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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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    06

    Amitriptyline Hydrochloride

    Israel

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    Certificate Number : CEP 2001-432 - Rev 06

    Issue Date : 2025-03-11

    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

    Latest Date of Registration :

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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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    NDC Package Code : 15894-0033

    Start Marketing Date : 2019-01-23

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    07

    Bromocriptine Mesylate

    Israel

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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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

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

    Marketing Category : BULK INGREDIENT

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    Available Reg. Filing : BR, CA
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    Cabergoline

    Israel

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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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

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

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    Carbidopa

    Israel

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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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

     CEP/COS arrow-down
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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)

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    Clopidogrel

    Israel

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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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

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    NDC KDMF arrow-down
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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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