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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 1Allopurinol

    13 1Alpelisib

    14 1Amcinonide

    15 2Amitriptyline 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

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    43 1Bivalirudin

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    47 1Brexpiprazole

    48 1Bromocriptine Mesylate

    49 2Budesonide

    50 1Buprenorphine

    51 1Buprenorphine Hydrochloride

    52 1Butorphanol Tartrate

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    54 1Cabergoline

    55 1Calcipotriol

    56 1Calcitriol

    57 1Candesartan Cilexetil

    58 1Cantharidin

    59 1Capecitabine

    60 1Capivasertib

    61 1Capmatinib

    62 2Carbamazepine

    63 2Carbidopa

    64 1Carboplatin

    65 1Carfilzomib

    66 1Carvedilol

    67 1Carvedilol Phosphate

    68 2Caspofungin

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    107 1Desonide

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    110 1Deutetrabenazine

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    116 1Dihydroergocristine

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    122 1Disodium Pamidronate Pentahydrate

    123 1Docetaxel

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    140 2Epirubicin Hydrochloride

    141 1Eptifibatide

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    143 1Ergometrine

    144 1Ergonovine Maleate

    145 2Ergotamine Tartrate

    146 1Erlotinib Hydrochloride

    147 2Eszopiclone

    148 1Etilevodopa

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    150 1Etoposide

    151 1Etrasimod

    152 1Exenatide

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    154 1Famciclovir

    155 1Febuxostat

    156 1Fedratinib

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    158 1Ferric Citrate

    159 2Fexofenadine Hydrochloride

    160 1Fidaxomicin

    161 1Filgrastim

    162 1Finerenone

    163 1Fingolimod Hydrochloride

    164 1Fludarabine Phosphate

    165 1Fludrocortisone Acetate

    166 2Flunisolide

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    174 1Fluticasone Propionate

    175 1Fluvastatin Sodium

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    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 2Imipramine Hydrochloride

    200 1Imiquimod

    201 2Irbesartan

    202 1Iron Sucrose

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    204 1Ixazomib Citrate

    205 2Labetalol Hydrochloride

    206 1Lacosamide

    207 1Lamotrigine

    208 1Lansoprazole

    209 1Larotrectinib

    210 1Latanoprost

    211 1Lemborexant

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    213 1Letermovir

    214 1Letrozole

    215 1Leuprolide Acetate

    216 1Levalbuterol Hydrochloride

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    218 1Levofloxacin

    219 1Linaclotide

    220 1Linagliptin

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    227 1Lorlatinib

    228 2Losartan Potassium

    229 1Lotilaner

    230 1Lovastatin

    231 1Lr-103

    232 1Lubiprostone

    233 1Lumateperone Tosylate

    234 1Lurasidone Hydrochloride

    235 1Macitentan

    236 1Mavacamten

    237 1Maxacalcitol

    238 1Medroxyprogesterone Acetate

    239 1Megestrol Acetate

    240 1Memantine Hydrochloride

    241 1Mesalazine

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    243 1Methyldopa

    244 1Methylergonovine

    245 1Methylergonovine Maleate

    246 1Metopimazine

    247 1Metoprolol Succinate

    248 2Metoprolol Tartrate

    249 1Micafungin

    250 1Midostaurin

    251 1Migalastat

    252 1Mirtazapine

    253 2Misoprostol

    254 1Mitomycin

    255 1Mitoxantrone

    256 1Modafinil

    257 1Momelotinib

    258 1Mometasone Furoate

    259 2Montelukast Sodium

    260 2Mupirocin

    261 2Mupirocin Calcium

    262 1Mycophenolate Mofetil

    263 1Mycophenolate Sodium

    264 1Nabumetone

    265 2Naproxen

    266 1Nateglinide

    267 1Nefazodone Hydrochloride

    268 1Neratinib

    269 2Nicergoline

    270 1Nifedipine

    271 2Nilotinib

    272 1Nintedanib Esylate

    273 1Niraparib Tosylate

    274 1Nirogacestat Hydrobromide

    275 1Nitrofurantoin

    276 1Nomegestrol Acetate

    277 1Norgestimate

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    279 1Octreotide Acetate

    280 1Olanzapine

    281 2Olmesartan Medoxomil

    282 1Olodaterol Hydrochloride

    283 1Omeprazole

    284 1Ondansetron

    285 2Ondansetron Hydrochloride

    286 1Osimertinib Mesylate

    287 1Oxacillin Sodium

    288 1Oxaliplatin

    289 1Oxazepam

    290 4Paclitaxel

    291 1Pacritinib

    292 1Palbociclib

    293 1Paliperidone

    294 1Paliperidone Palmitate

    295 2Palonosetron

    296 1Pancuronium Bromide

    297 2Pantoprazole Sodium

    298 1Paricalcitol

    299 1Paroxetine Hydrochloride

    300 1Pemetrexed

    301 1Pemetrexed Disodium

    302 1Penicillin G Sulfoxide

    303 1Penicillin V Potassium

    304 1Pentoxifylline

    305 1Perampanel

    306 1Pergolide Mesylate

    307 1Pioglitazone Hydrochloride

    308 1Pirtobrutinib

    309 1Ponesimod

    310 1Potassium Citrate

    311 1Pralatrexate

    312 1Prasterone

    313 1Prasugrel Hydrobromide

    314 1Prasugrel Hydrochloride

    315 2Pravastatin

    316 1Prednicarbate

    317 1Prednisolone

    318 2Pregabalin

    319 1Probenecid

    320 3Quetiapine Hemifumarate

    321 2Raloxifene Hydrochloride

    322 1Ramelteon

    323 1Rasagiline Mesylate

    324 1Relugolix

    325 1Ribociclib

    326 1Rilpivirine Hydrochloride

    327 1Rimegepant Sulfate

    328 1Ripretinib

    329 1Risdiplam

    330 1Risedronate Sodium

    331 1Risperidone

    332 1Ritlecitinib

    333 1Rivaroxaban

    334 1Rocuronium Bromide

    335 1Romidepsin

    336 1Rosiglitazone Maleate

    337 3Rosuvastatin Calcium

    338 1Rotigotine

    339 1Roxadustat

    340 1Rusfertide

    341 1Sacubitril-Valsartan

    342 1Salbutamol Sulphate

    343 1Samidorphan

    344 1Saxagliptin

    345 1Selegiline Hydrochloride

    346 1Semaglutide

    347 1Sertraline Hydrochloride

    348 1Sildenafil Citrate

    349 1Silver Sulfadiazine

    350 1Silymarin

    351 2Simvastatin

    352 3Sitagliptin Malate

    353 3Sitagliptin Phosphate

    354 1Sodium Dicloxacillin

    355 2Sofosbuvir

    356 2Solifenacin Succinate

    357 1Sorafenib

    358 1Sotagliflozin

    359 1Sotorasib

    360 1Sparsentan

    361 1Sugammadex Sodium

    362 2Sulfamethoxazole

    363 1Sunitinib

    364 2Tacrolimus

    365 1Tadalafil

    366 1Tafamidis

    367 1Tafamidis Meglumine

    368 1Tamoxifen Citrate

    369 1Tapinarof

    370 1Telmisartan

    371 1Telotristat Etiprate

    372 3Terazosin HCl

    373 1Terbinafine Hydrochloride

    374 1Terfenadine

    375 1Terguride hydrogen maleate

    376 1Teriparatide Acetate

    377 1Thiotepa

    378 2Ticagrelor

    379 1Ticlopidine

    380 1Tigecycline

    381 1Timolol Maleate

    382 1Tiotropium Bromide

    383 1Tirzepatide

    384 1Tivozanib

    385 2Tobramycin

    386 1Tolterodine Tartrate

    387 2Torsemide

    388 2Trazodone Hydrochloride

    389 1Triamcinolone

    390 2Triamcinolone Acetonide

    391 1Triheptanoin

    392 1Trilaciclib

    393 1Trimethoprim

    394 1Trimipramine

    395 1Tucatinib

    396 1Ulipristal Acetate

    397 1Umeclidinium Bromide

    398 1Upadacitinib

    399 1Valacyclovir Hydrochloride

    400 1Valbenazine Tosylate

    401 1Valrubicin

    402 1Vamorolone

    403 1Varenicline Tartrate

    404 1Vecuronium Bromide

    405 1Venetoclax

    406 2Venlafaxine Hydrochloride

    407 1Verapamil Hydrochloride

    408 1Vericiguat

    409 1Vilanterol Trifenatate

    410 1Vilazodone Hydrochloride

    411 1Voclosporin

    412 1Warfarin Sodium

    413 1Zaleplon

    414 1Zanubrutinib

    415 1Zavegepant HCl

    416 1Zoledronate Disodium

    417 1Zoledronic Acid

    418 1Zolmitriptan

    419 2Zolpidem Tartrate

    420 1Zonisamide

    421 1Zuranolone

    422 6Blank

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    Bromocriptine Mesylate

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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

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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

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    Cabergoline

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    DMF Review : Reviewed

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    DMF Number : 18113

    Submission : 2005-02-21

    Status : Active

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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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    Cyclosporine

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    DMF Review : Reviewed

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    Pay. Date : 2012-11-07

    DMF Number : 12932

    Submission : 1998-04-02

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    Certificate Number : CEP 2002-152 - Rev 07

    Issue Date : 2025-03-11

    Type : Chemical

    Substance Number : 994

    Status : Valid

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    Registration Number : 305MF10110

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

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    Diltiazem Hydrochloride

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    DMF Review : Reviewed

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    Pay. Date : 2012-11-08

    DMF Number : 7239

    Submission : 1987-11-30

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    Registration Number : 225MF10001

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

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    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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    Ergotamine Tartrate

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    DMF Review : Reviewed

    Rev. Date : 2012-11-23

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    DMF Number : 24782

    Submission : 2011-03-23

    Status : Active

    Type : II

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    Certificate Number : CEP 2007-328 - Rev 04

    Issue Date : 2025-01-13

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    Substance Number : 224

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    Registration Number : 307MF10007

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    06

    Ezetimibe

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    DMF Review : Reviewed

    Rev. Date : 2013-04-17

    Pay. Date : 2013-04-04

    DMF Number : 20039

    Submission : 2006-12-13

    Status : Active

    Type : II

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    Registration Number : 231MF10028

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

    Initial Date of Registration : 2019-02-05

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    Date of Issue : 2025-04-24

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    NDC Package Code : 15894-0011

    Start Marketing Date : 2017-11-17

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Samoh Pharmaceutical Co., Ltd.

    Registration Date : 2010-12-15

    Registration Number : 711-8-ND

    Manufacturer Name : Teva API India Pvt. Ltd

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

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    07

    Fluoxetine Hydrochloride

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    DMF Review : Reviewed

    Rev. Date : 2017-02-22

    Pay. Date : 2017-02-06

    DMF Number : 12146

    Submission : 1996-10-02

    Status : Active

    Type : II

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    Certificate Number : CEP 1997-042 - Rev 12

    Issue Date : 2025-03-12

    Type : Chemical

    Substance Number : 1104

    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 : 15894-0039

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    End Marketing Date : 2025-12-31

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    Methyldopa

    Israel

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    GDUFA

    DMF Review : Reviewed

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    DMF Number : 26726

    Submission : 2013-01-24

    Status : Active

    Type : II

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    Registration Number : 227MF10141

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

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    Date of Issue : 2025-04-24

    Valid Till : 2028-05-25

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    NDC Package Code : 15894-0038

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    End Marketing Date : 2025-12-31

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    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 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 : 2025-12-31

    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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    Mycophenolate Mofetil

    Israel

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-23

    Pay. Date : 2012-11-09

    DMF Number : 20072

    Submission : 2006-12-20

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2005-239 - Rev 06

    Issue Date : 2025-05-28

    Type : Chemical

    Substance Number : 1700

    Status : Valid

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    Registration Number : 224MF10107

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

    Initial Date of Registration : 2012-06-22

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