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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

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    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

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    34 3Beclomethasone Dipropionate

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    37 1Bempedoic Acid

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    40 1Betamethasone Dipropionate

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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

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    63 2Carbidopa

    64 1Carboplatin

    65 1Carfilzomib

    66 1Carvedilol

    67 1Carvedilol Phosphate

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    146 1Erlotinib Hydrochloride

    147 2Eszopiclone

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    150 1Etoposide

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    155 1Febuxostat

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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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    175 1Fluvastatin Sodium

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    187 1Glatiramer Acetate

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    190 1Haloperidol

    191 1Haloperidol Decanoate

    192 2Hydrochlorothiazide

    193 1Hydrocortisone Butyrate

    194 1Ibandronate Sodium

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    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

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    207 1Lamotrigine

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    210 1Latanoprost

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    216 1Levalbuterol Hydrochloride

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    232 1Lubiprostone

    233 1Lumateperone Tosylate

    234 1Lurasidone Hydrochloride

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    236 1Mavacamten

    237 1Maxacalcitol

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    239 1Megestrol Acetate

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    241 1Mesalazine

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    244 1Methylergonovine

    245 1Methylergonovine Maleate

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    250 1Midostaurin

    251 1Migalastat

    252 1Milk Thistle Extract

    253 1Mirtazapine

    254 2Misoprostol

    255 1Mitomycin

    256 1Mitoxantrone

    257 1Modafinil

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    259 1Mometasone Furoate

    260 2Montelukast Sodium

    261 2Mupirocin

    262 2Mupirocin Calcium

    263 1Mycophenolate Mofetil

    264 1Mycophenolate Sodium

    265 1Nabumetone

    266 2Naproxen

    267 1Nateglinide

    268 1Nefazodone Hydrochloride

    269 1Neratinib

    270 2Nicergoline

    271 1Nifedipine

    272 2Nilotinib

    273 1Nintedanib Esylate

    274 1Niraparib Tosylate

    275 1Nirogacestat Hydrobromide

    276 1Nitrofurantoin

    277 1Nomegestrol Acetate

    278 1Norgestimate

    279 1Nusinersen Sodium

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    281 1Olanzapine

    282 2Olmesartan Medoxomil

    283 1Olodaterol Hydrochloride

    284 1Omeprazole

    285 1Ondansetron

    286 2Ondansetron Hydrochloride

    287 1Osimertinib Mesylate

    288 1Oxacillin Sodium

    289 1Oxaliplatin

    290 1Oxazepam

    291 4Paclitaxel

    292 1Pacritinib

    293 1Palbociclib

    294 1Paliperidone

    295 1Paliperidone Palmitate

    296 2Palonosetron

    297 1Pancuronium Bromide

    298 2Pantoprazole Sodium

    299 1Paricalcitol

    300 1Paroxetine Hydrochloride

    301 1Pemetrexed

    302 1Pemetrexed Disodium

    303 1Penicillin G Sulfoxide

    304 1Penicillin V Potassium

    305 1Pentoxifylline

    306 1Perampanel

    307 1Pergolide Mesylate

    308 1Pioglitazone Hydrochloride

    309 1Pirtobrutinib

    310 1Ponesimod

    311 1Potassium Citrate

    312 1Pralatrexate

    313 1Prasterone

    314 1Prasugrel Hydrobromide

    315 1Prasugrel Hydrochloride

    316 2Pravastatin

    317 1Prednicarbate

    318 1Prednisolone

    319 2Pregabalin

    320 1Probenecid

    321 3Quetiapine Hemifumarate

    322 2Raloxifene Hydrochloride

    323 1Ramelteon

    324 1Rasagiline Mesylate

    325 1Relugolix

    326 1Ribociclib

    327 1Rilpivirine Hydrochloride

    328 1Rimegepant Sulfate

    329 1Ripretinib

    330 1Risdiplam

    331 1Risedronate Sodium

    332 1Risperidone

    333 1Ritlecitinib

    334 1Rivaroxaban

    335 1Rocuronium Bromide

    336 1Romidepsin

    337 1Rosiglitazone Maleate

    338 3Rosuvastatin Calcium

    339 1Rotigotine

    340 1Roxadustat

    341 1Rusfertide

    342 1Sacubitril-Valsartan

    343 1Salbutamol Sulphate

    344 1Samidorphan

    345 1Saxagliptin

    346 1Selegiline Hydrochloride

    347 1Semaglutide

    348 1Sertraline Hydrochloride

    349 1Sildenafil Citrate

    350 1Silver Sulfadiazine

    351 1Silymarin

    352 2Simvastatin

    353 3Sitagliptin Malate

    354 3Sitagliptin Phosphate

    355 1Sodium Dicloxacillin

    356 2Sofosbuvir

    357 2Solifenacin Succinate

    358 1Sorafenib

    359 1Sotagliflozin

    360 1Sotorasib

    361 1Sparsentan

    362 1Sugammadex Sodium

    363 2Sulfamethoxazole

    364 1Sunitinib

    365 2Tacrolimus

    366 1Tadalafil

    367 1Tafamidis

    368 1Tafamidis Meglumine

    369 1Tamoxifen Citrate

    370 1Tapinarof

    371 1Telmisartan

    372 1Telotristat Etiprate

    373 3Terazosin HCl

    374 1Terbinafine Hydrochloride

    375 1Terfenadine

    376 1Terguride hydrogen maleate

    377 1Teriparatide Acetate

    378 1Thiotepa

    379 2Ticagrelor

    380 1Ticlopidine

    381 1Tigecycline

    382 1Timolol Maleate

    383 1Tiotropium Bromide

    384 1Tirzepatide

    385 1Tivozanib

    386 2Tobramycin

    387 1Tolterodine Tartrate

    388 2Torsemide

    389 2Trazodone Hydrochloride

    390 1Triamcinolone

    391 2Triamcinolone Acetonide

    392 1Triheptanoin

    393 1Trilaciclib

    394 1Trimethoprim

    395 1Trimipramine

    396 1Tucatinib

    397 1Ulipristal Acetate

    398 1Umeclidinium Bromide

    399 1Upadacitinib

    400 1Valacyclovir Hydrochloride

    401 1Valbenazine Tosylate

    402 1Valrubicin

    403 1Vamorolone

    404 1Varenicline Tartrate

    405 1Vecuronium Bromide

    406 1Venetoclax

    407 2Venlafaxine Hydrochloride

    408 1Verapamil Hydrochloride

    409 1Vericiguat

    410 1Vilanterol Trifenatate

    411 1Vilazodone Hydrochloride

    412 1Voclosporin

    413 1Warfarin Sodium

    414 1Zaleplon

    415 1Zanubrutinib

    416 1Zavegepant HCl

    417 1Zoledronate Disodium

    418 1Zoledronic Acid

    419 1Zolmitriptan

    420 2Zolpidem Tartrate

    421 1Zonisamide

    422 1Zuranolone

    423 6Blank

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    Bromocriptine Mesylate

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    GDUFA

    DMF Review : Reviewed

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    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

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    Cabergoline

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    DMF Review : Reviewed

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    Submission : 2005-02-21

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    Certificate Number : CEP 2006-170 - Rev 05

    Issue Date : 2024-12-17

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    Substance Number : 1773

    Status : Valid

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    Registration Number : 217MF11279

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

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    Cyclosporine

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    DMF Review : Reviewed

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    DMF Number : 12932

    Submission : 1998-04-02

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    Certificate Number : CEP 2002-152 - Rev 07

    Issue Date : 2025-03-11

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    Substance Number : 994

    Status : Valid

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    Registration Number : 305MF10110

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    Diltiazem Hydrochloride

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    DMF Review : Reviewed

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    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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    Registrant Name : Korea Unipharm Co., Ltd.

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    Ergotamine Tartrate

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    DMF Review : Reviewed

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    DMF Number : 24782

    Submission : 2011-03-23

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    Certificate Number : CEP 2007-328 - Rev 04

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    Registration Number : 307MF10007

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    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

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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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    CPhI WW Frankfurt
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-05-07

    Pay. Date : 2012-12-20

    DMF Number : 26726

    Submission : 2013-01-24

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
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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

    Written Confirmation Number : WC-0002

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    NDC Package Code : 15894-0038

    Start Marketing Date : 2022-01-24

    End Marketing Date : 2025-12-31

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    Montelukast Sodium

    Israel

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    CPhI WW Frankfurt
    Booth #6.1A32
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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

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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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    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

     JDMF arrow-down
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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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