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    01 1Abaloparatide Acetate

    02 1Abemaciclib

    03 1Abiraterone Acetate

    04 1Abrocitinib

    05 1Acetic Acid

    06 1Aciclovir

    07 1Adagrasib

    08 1Afatinib

    09 1Alclometasone Dipropionate

    10 1Alendronate Sodium

    11 1Alfacalcidol

    12 2Allopurinol

    13 1Alpelisib

    14 1Amcinonide

    15 2Amitriptyline Hydrochloride

    16 1Anastrozole

    17 1Apalutamide

    18 1Apixaban

    19 1Aripiprazole

    20 1Asciminib

    21 2Atenolol

    22 1Atomoxetin Hydrochloride

    23 3Atorvastatin

    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 284461-73-0

    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 1Clopidogrel

    90 1Cloxacillin Sodium

    91 3Conjugated Estrogens

    92 1Crisaborole

    93 1Cyclacillin

    94 4Cyclosporine

    95 1Cyproterone Acetate

    96 1Dabigatran 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 2Doxepin 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 1Ergotamine Tartrate

    147 1Erlotinib Hydrochloride

    148 2Eszopiclone

    149 1Etilevodopa

    150 1Etodolac

    151 1Etoposide

    152 1Etrasimod

    153 1Exenatide

    154 2Ezetimibe

    155 1Famciclovir

    156 1Febuxostat

    157 1Fedratinib

    158 1Ferric Carboxymaltose

    159 1Ferric Citrate

    160 2Fexofenadine Hydrochloride

    161 1Fidaxomicin

    162 1Filgrastim

    163 1Finerenone

    164 1Fingolimod Hydrochloride

    165 1Fludarabine Phosphate

    166 1Fludrocortisone Acetate

    167 2Flunisolide

    168 2Fluocinolone Acetonide

    169 2Fluocinonide

    170 1Fluorometholone

    171 1Fluorometholone Acetate

    172 1Fluorouracil

    173 1Fluoxetine Hydrochloride

    174 1Fluticasone Furoate

    175 1Fluticasone Propionate

    176 1Fluvastatin Sodium

    177 1Fluvoxamine

    178 1Formoterol Fumarate

    179 1Fosamprenavir

    180 2Fulvestrant

    181 1Furosemide

    182 2Gabapentin

    183 1Galantamine Hydrobromide

    184 1Gatifloxacin

    185 2Gemcitabine

    186 1Gemfibrozil

    187 1Glasdegib

    188 1Glatiramer Acetate

    189 1Glycerol Phenylbutyrate

    190 1Halobetasol

    191 1Haloperidol

    192 1Haloperidol Decanoate

    193 2Hydrochlorothiazide

    194 1Hydrocortisone Butyrate

    195 1Ibandronate Sodium

    196 1Ibrutinib

    197 1Icatibant Acetate

    198 1Idarubicin Hydrochloride

    199 2Imatinib Mesylate

    200 1Imipramine

    201 1Imipramine Hydrochloride

    202 1Imiquimod

    203 3Irbesartan

    204 1Iron Sucrose

    205 1Ivosidenib

    206 1Ixazomib Citrate

    207 2Labetalol Hydrochloride

    208 1Lacosamide

    209 1Lamotrigine

    210 1Lansoprazole

    211 1Larotrectinib

    212 1Latanoprost

    213 1Lemborexant

    214 1Lenalidomide

    215 1Letermovir

    216 1Letrozole

    217 1Leuprolide Acetate

    218 1Levalbuterol Hydrochloride

    219 1Levetiracetam

    220 1Levofloxacin

    221 1Linaclotide

    222 1Linagliptin

    223 1Linezolid

    224 1Lisinopril

    225 1Lisuride

    226 1Lisuride Maleate

    227 1Loperamide Hydrochloride

    228 1Lorazepam

    229 1Lorlatinib

    230 3Losartan Potassium

    231 1Lotilaner

    232 1Lovastatin

    233 1Lr-103

    234 1Lubiprostone

    235 1Lumateperone Tosylate

    236 1Lurasidone Hydrochloride

    237 1Macitentan

    238 1Mavacamten

    239 1Maxacalcitol

    240 1Medroxyprogesterone Acetate

    241 1Megestrol Acetate

    242 1Memantine Hydrochloride

    243 1Mesalazine

    244 1Metformin

    245 2Methyldopa

    246 1Methylergonovine

    247 1Methylergonovine Maleate

    248 1Metopimazine

    249 1Metoprolol Succinate

    250 2Metoprolol Tartrate

    251 1Micafungin

    252 1Midostaurin

    253 1Migalastat

    254 1Mirtazapine

    255 2Misoprostol

    256 1Mitomycin

    257 1Mitoxantrone

    258 2Modafinil

    259 1Momelotinib

    260 1Mometasone Furoate

    261 2Montelukast Sodium

    262 2Mupirocin

    263 2Mupirocin Calcium

    264 1Mycophenolate Mofetil

    265 1Mycophenolate Sodium

    266 1Nabumetone

    267 2Naproxen

    268 1Naproxen Sodium

    269 1Nateglinide

    270 1Nefazodone Hydrochloride

    271 1Neratinib

    272 1Nicergoline

    273 1Nifedipine

    274 2Nilotinib

    275 1Nintedanib Esylate

    276 1Niraparib Tosylate

    277 1Nirogacestat Hydrobromide

    278 1Nitisinone

    279 1Nitrofurantoin

    280 1Nomegestrol Acetate

    281 1Norgestimate

    282 1Nusinersen Sodium

    283 1Octreotide Acetate

    284 1Olanzapine

    285 1Olmesartan Medoxomil

    286 1Olodaterol Hydrochloride

    287 1Omeprazole

    288 1Ondansetron

    289 2Ondansetron Hydrochloride

    290 1Osimertinib Mesylate

    291 1Oxacillin Sodium

    292 1Oxaliplatin

    293 1Oxazepam

    294 4Paclitaxel

    295 1Pacritinib

    296 1Palbociclib

    297 1Paliperidone

    298 1Paliperidone Palmitate

    299 2Palonosetron

    300 1Pancuronium Bromide

    301 2Pantoprazole Sodium

    302 1Paricalcitol

    303 1Paroxetine Hydrochloride

    304 1Pemetrexed

    305 1Pemetrexed Disodium

    306 1Penicillin G Sulfoxide

    307 1Penicillin V Potassium

    308 1Pentoxifylline

    309 1Perampanel

    310 1Pergolide Mesylate

    311 1Pioglitazone Hydrochloride

    312 1Pirtobrutinib

    313 1Ponesimod

    314 2Potassium Citrate

    315 1Pralatrexate

    316 1Prasterone

    317 1Prasugrel Hydrobromide

    318 1Prasugrel Hydrochloride

    319 1Pravastatin

    320 1Prednicarbate

    321 1Prednisolone

    322 2Pregabalin

    323 1Probenecid

    324 2Quetiapine Hemifumarate

    325 2Raloxifene Hydrochloride

    326 1Ramelteon

    327 1Rasagiline Mesylate

    328 1Relugolix

    329 1Ribociclib

    330 1Rimegepant Sulfate

    331 1Ripretinib

    332 1Risdiplam

    333 1Risedronate Sodium

    334 1Risperidone

    335 1Ritlecitinib

    336 1Rivaroxaban

    337 1Rocuronium Bromide

    338 1Romidepsin

    339 1Rosiglitazone Maleate

    340 3Rosuvastatin Calcium

    341 1Rotigotine

    342 1Roxadustat

    343 1Rusfertide

    344 1Sacubitril-Valsartan

    345 1Salbutamol Sulphate

    346 1Samidorphan L-Malate

    347 1Saxagliptin

    348 1Selegiline Hydrochloride

    349 1Semaglutide

    350 1Sertraline Hydrochloride

    351 1Sildenafil Citrate

    352 1Silver Sulfadiazine

    353 1Silybum Marianum L.

    354 1Silymarin

    355 2Simvastatin

    356 1Sitagliptin Malate

    357 3Sitagliptin Phosphate

    358 1Sodium Dicloxacillin

    359 2Sofosbuvir

    360 2Solifenacin Succinate

    361 1Sorafenib

    362 1Sotagliflozin

    363 1Sotorasib

    364 1Sparsentan

    365 1Sugammadex Sodium

    366 2Sulfamethoxazole

    367 1Sunitinib

    368 1Tacrolimus

    369 1Tadalafil

    370 1Tafamidis

    371 1Tafamidis Meglumine

    372 1Tamoxifen Citrate

    373 1Tapinarof

    374 1Telmisartan

    375 1Telotristat Etiprate

    376 3Terazosin HCl

    377 1Terbinafine Hydrochloride

    378 1Terfenadine

    379 1Terguride hydrogen maleate

    380 1Teriparatide Acetate

    381 1Thiotepa

    382 1Ticagrelor

    383 1Ticlopidine

    384 1Tigecycline

    385 1Timolol Maleate

    386 1Tiotropium Bromide

    387 1Tirzepatide

    388 1Tivozanib

    389 1Tobramycin

    390 1Tolterodine Tartrate

    391 2Torsemide

    392 2Trazodone Hydrochloride

    393 1Triamcinolone

    394 2Triamcinolone Acetonide

    395 1Triheptanoin

    396 1Trilaciclib

    397 1Trimethoprim

    398 1Trimipramine

    399 1Tucatinib

    400 1Ulipristal Acetate

    401 1Umeclidinium Bromide

    402 1Upadacitinib

    403 1Valacyclovir Hydrochloride

    404 1Valbenazine Tosylate

    405 1Valrubicin

    406 2Valsartan

    407 1Vamorolone

    408 1Vecuronium Bromide

    409 1Venetoclax

    410 2Venlafaxine Hydrochloride

    411 1Verapamil Hydrochloride

    412 1Vericiguat

    413 1Vilanterol Trifenatate

    414 1Vilazodone Hydrochloride

    415 1Voclosporin

    416 1Warfarin Sodium

    417 1Zaleplon

    418 1Zanubrutinib

    419 1Zavegepant HCl

    420 1Zoledronate Disodium

    421 1Zoledronic Acid

    422 1Zolmitriptan

    423 2Zolpidem Tartrate

    424 1Zonisamide

    425 1Zuranolone

    426 4Blank

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    01

    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 : R0-CEP 2023-006 - Rev 00

    Issue Date : 2023-07-06

    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 : 2022-06-22

    Valid Till : 2025-05-20

    Written Confirmation Number : WC-0001

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    NDC Package Code : 15894-0028

    Start Marketing Date : 2015-12-14

    End Marketing Date : 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 : 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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    02

    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

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    Certificate Number : CEP 2020-375 - Rev 02

    Issue Date : 2024-02-08

    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 : 2019-06-17

    Valid Till : 2022-05-26

    Written Confirmation Number : WC-0002

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    NDC Package Code : 15894-0016

    Start Marketing Date : 2019-03-26

    End Marketing Date : 2025-12-31

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    Marketing Category : BULK INGREDIENT

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    Registrant Name : Samoh Pharmaceutical Co., Ltd.

    Registration Date : 2015-12-02

    Registration Number : 2991-23-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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    03

    Amitriptyline Hydrochloride

    Israel

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    Certificate Number : CEP 2001-432 - Rev 05

    Issue Date : 2024-05-07

    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 : 2022-06-22

    Valid Till : 2025-05-20

    Written Confirmation Number : WC-0001

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    NDC Package Code : 15894-0033

    Start Marketing Date : 2019-01-23

    End Marketing Date : 2025-12-31

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    Marketing Category : BULK INGREDIENT

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    04

    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 03

    Issue Date : 2024-02-05

    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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    05

    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 : R1-CEP 2017-260 - Rev 00

    Issue Date : 2023-03-30

    Type : Chemical

    Substance Number : 2531

    Status : Valid

     JDMF EU-WCarrow-down
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    Date of Issue : 2022-06-22

    Valid Till : 2025-05-20

    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@[Intermediate 'Clopidogrel Camsylate' Manufacturing Plant] Plot Nos, A-2, A-2/1, A-2/2, UPSIDC Industrial Area, Gajraula Distt. Amroha(Uttar Pradesh), India

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    06

    Cyclosporine

    Israel

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-29

    Pay. Date : 2012-11-07

    DMF Number : 12932

    Submission : 1998-04-02

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2002-152 - Rev 06

    Issue Date : 2023-06-21

    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

    Initial Date of Registration : 2023-09-20

    Latest Date of Registration :

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    Imipramine Hydrochloride

    Israel

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 1906

    Submission : 1972-03-08

    Status : Active

    Type : II

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    Certificate Number : CEP 2002-051 - Rev 04

    Issue Date : 2024-01-30

    Type : Chemical

    Substance Number : 29

    Status : Valid

     JDMF EU-WCarrow-down
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    Date of Issue : 2022-06-22

    Valid Till : 2025-05-20

    Written Confirmation Number : WC-0001

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    NDC Package Code : 15894-0034

    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 : Samoh Pharmaceutical Co., Ltd.

    Registration Date : 2021-05-04

    Registration Number : 20210504-209-J-976

    Manufacturer Name : Teva API (India) Private Limited

    Manufacturer Address : Q1 to Q4 Industrial Area, Ghirongi Malanpur Bhind, Madhya Pradesh State, India

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    Irbesartan

    Israel

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    DMF Review : N/A

    Rev. Date :

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    DMF Number : 17394

    Submission : 2004-05-18

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2010-322 - Rev 02

    Issue Date : 2022-03-07

    Type : Chemical

    Substance Number : 2465

    Status : Valid

     JDMF EU-WCarrow-down
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    Date of Issue : 2022-06-22

    Valid Till : 2025-05-20

    Written Confirmation Number : WC-0001

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    NDC Package Code : 15894-0008

    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 : Samchundang Pharmaceutical Co., Ltd.

    Registration Date : 2014-04-24

    Registration Number : 20120806-133-H-212-22(1)

    Manufacturer Name : Teva API India Ltd.

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

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    Methyldopa

    Israel

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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 arrow-down
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    Certificate Number : CEP 2010-182 - Rev 04

    Issue Date : 2024-06-06

    Type : Chemical

    Substance Number : 45

    Status : Valid

     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

    Initial Date of Registration : 2015-05-14

    Latest Date of Registration :

    EU-WC NDC arrow-down
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    NDC Package Code : 15894-0038

    Start Marketing Date : 2022-01-24

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    10

    Mupirocin Calcium

    Israel

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-23

    Pay. Date : 2012-11-09

    DMF Number : 20041

    Submission : 2006-12-14

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2008-158 - Rev 03

    Issue Date : 2022-04-01

    Type : Chemical

    Substance Number : 1451

    Status : Valid

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    Registration Number : 229MF10219

    Registrant's Address : 13 Pallagi u(´)t, Debrecen, 4042-Hungary

    Initial Date of Registration : 2017-12-12

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