Product Name Tapi · PDF fileMethylergonovine maleate Methylprednisolone sodium succinate...

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Transcript of Product Name Tapi · PDF fileMethylergonovine maleate Methylprednisolone sodium succinate...

Page 1: Product Name Tapi · PDF fileMethylergonovine maleate Methylprednisolone sodium succinate Micafungin sodium Mitomycin Mycophenolate mofetil Octreotide acetate
Page 2: Product Name Tapi · PDF fileMethylergonovine maleate Methylprednisolone sodium succinate Micafungin sodium Mitomycin Mycophenolate mofetil Octreotide acetate

Product Name TapiIP

Tech File** USDMF

CEP EUDMF

JapanDMF

KoreaDMF

Abaloparatide

Abiraterone Acetate

Acyclovir CEP

Afatinib *

Alclometasone dipropionate

Alendronate sodium *

Allopurinol CEP

Amcinonide

Amitriptyline HCl CEP

Amlodipine besylate * CEP

Anastrozole CEP

Anidulafungin

Apixaban

Apremilast *

Aripiprazole

Atenolol CEP

Atomoxetine HCl

Atorvastatin calcium * CEP

Atosiban Acetate

Atracurium besylate CEP

Azacitidine

Azithromycin dihydrate CEP

Aztreonam

Beclomethasone dipropionate * CEP

Betamethasone acetate

Betamethasone base CEP

Betamethasone dipropionate CEP

Betamethasone valerate CEP

Bicalutamide CEP

Bimatoprost

Bivalirudin

* TAPI can provide several different polymorphs or processes of this product.To obtain complete DMF files of a specific product's polymorph or process, please contact your account manager.

Additional DMFs or Tech Files are available upon request** Tech File relevant only for products prior to 1st DMF All subject to the disclaimer on the last page

Page 3: Product Name Tapi · PDF fileMethylergonovine maleate Methylprednisolone sodium succinate Micafungin sodium Mitomycin Mycophenolate mofetil Octreotide acetate

Product Name TapiIP

Tech File** USDMF

CEP EUDMF

JapanDMF

KoreaDMF

Bleomycin sulfate

Bortezomib

Brexpiprazole

Bromocriptine mesylate CEP

Budesonide * CEP

Buprenorphine base CEP

Buprenorphine HCl CEP

Butorphanol tartrate

Cabazitaxel

Cabergoline CEP

Calcipotriene * CEP

Calcitriol CEP

Capecitabine CEP

Carbidopa CEP

Carboplatin CEP

Carfilzomib

Carvedilol base CEP

Carvedilol phosphate

Caspofungin acetate

Chlormadinone acetate

Ciclosporin CEP

Cilostazol

Cinacalcet HCl

Cisatracurium besylate CEP

Cisplatin CEP

Clarithromycin CEP

Clobetasol propionate CEP

Clopidogrel bisulfate * CEP

Cobicistat

Crisaborole

Cyproterone acetate CEP

* TAPI can provide several different polymorphs or processes of this product.To obtain complete DMF files of a specific product's polymorph or process, please contact your account manager.

Additional DMFs or Tech Files are available upon request** Tech File relevant only for products prior to 1st DMF All subject to the disclaimer on the last page

Page 4: Product Name Tapi · PDF fileMethylergonovine maleate Methylprednisolone sodium succinate Micafungin sodium Mitomycin Mycophenolate mofetil Octreotide acetate

Product Name TapiIP

Tech File** USDMF

CEP EUDMF

JapanDMF

KoreaDMF

Dabigatran etexilate

Darifenacin HBr

Dasatinib anhydrous *

Dasatinib monohydrate *

Daunorubicin HCl CEP

Deferasirox

Deferoxamine mesylate CEP

Deprodone propionate

Desloratadine

Desmopressin acetate CEP

Desonide

Desoxycorticosterone(Desoxycortone) PivalateDesvenlafaxine base

Desvenlafaxine fumarate

Desvenlafaxine succinate

Dexamethasone -17 valerate

Dexrazoxane (icrf)

Diazoxide

Diflorasone diacetate

Difluprednate

Dihydroergotamine mesylate CEP

Dihydroergotoxine mesylate CEP

Diltiazem HCl CEP

Dimethyl fumarate

Disodium Zoledronate

Docetaxel

Donepezil HCl *

Dorzolamide HCl CEP

Doxepin HCl CEP

Doxercalciferol

Doxorubicin HCl CEP

* TAPI can provide several different polymorphs or processes of this product.To obtain complete DMF files of a specific product's polymorph or process, please contact your account manager.

Additional DMFs or Tech Files are available upon request** Tech File relevant only for products prior to 1st DMF All subject to the disclaimer on the last page

Page 5: Product Name Tapi · PDF fileMethylergonovine maleate Methylprednisolone sodium succinate Micafungin sodium Mitomycin Mycophenolate mofetil Octreotide acetate

Product Name TapiIP

Tech File** USDMF

CEP EUDMF

JapanDMF

KoreaDMF

Drospirenone CEP

Duloxetine hydrochloride CEP

Edoxaban tosylate

Eldecalcitol

Eletriptan HBr

Eltrombopag olamine

Eluxadoline

Empagliflozin

Epirubicin HCl * CEP

Eptifibatide

Ergometrine (ergonovine) maleate CEP

Ergotamine tartrate CEP

Erlotinib HCl *

Eszopiclone

Etodolac CEP

Etoposide CEP

Exenatide

Ezetimibe

Famciclovir

Febuxostat

Fingolimod

Fludarabine phosphate CEP

Fludrocortisone acetate

Flunisolide

Fluocinolone acetonide *

Fluocinonide *

Fluorometholone acetate

Fluorometholone base

Fluorouracil - (5FU) CEP

Fluoxetine HCl CEP

Fluticasone furoate

* TAPI can provide several different polymorphs or processes of this product.To obtain complete DMF files of a specific product's polymorph or process, please contact your account manager.

Additional DMFs or Tech Files are available upon request** Tech File relevant only for products prior to 1st DMF All subject to the disclaimer on the last page

Page 6: Product Name Tapi · PDF fileMethylergonovine maleate Methylprednisolone sodium succinate Micafungin sodium Mitomycin Mycophenolate mofetil Octreotide acetate

Product Name TapiIP

Tech File** USDMF

CEP EUDMF

JapanDMF

KoreaDMF

Fluticasone propionate CEP

Fluvastatin sodium CEP

Fluvoxamine maleate

Formoterol fumarate CEP

Fulvestrant CEP

Furosemide CEP

Galantamine HBr CEP

Gemcitabine HCl CEP

Haloperidol

Haloperidol decanoate

Hydrochlorothiazide CEP

Ibrutinib *

Icatibant

Idarubicin HCl

Imatinib mesylate * CEP

Imipramine HCl CEP

Imiquimod

Irbesartan azide CEP

Ixazomib Citrate

Labetalol HCl CEP

Lamotrigine CEP

Lanreotide acetate

Lansoprazole CEP

Latanoprost

Latanoprostene bunod

Ledipasvir

Letrozole

Levodopa * CEP

Levofloxacin

Levosalbutamol HCl (levalbuterol)

Lifitegrast

* TAPI can provide several different polymorphs or processes of this product.To obtain complete DMF files of a specific product's polymorph or process, please contact your account manager.

Additional DMFs or Tech Files are available upon request** Tech File relevant only for products prior to 1st DMF All subject to the disclaimer on the last page

Page 7: Product Name Tapi · PDF fileMethylergonovine maleate Methylprednisolone sodium succinate Micafungin sodium Mitomycin Mycophenolate mofetil Octreotide acetate

Product Name TapiIP

Tech File** USDMF

CEP EUDMF

JapanDMF

KoreaDMF

Linaclotide

Linagliptin

Linezolid

Loperamide HCl CEP

Losartan potassium azide CEP

Lovastatin CEP

Lurasidone HCl

Macitentan

Medroxyprogesterone acetate CEP

Megestrol acetate CEP

Memantine HCl

Methyldopa CEP

Methylergonovine maleate CEP

Methylprednisolone hemisuccinate

Methylprednisolone sodiumsuccinate *Metoprolol succinate CEP

Metoprolol tartrate CEP

Micafungin sodium

Midostaurin

Mirtazapine CEP

Mitomycin CEP

Mometasone furoate *

Montelukast sodium CEP

Mupirocin CEP

Mupirocin calcium CEP

Mycophenolate mofetil CEP

Mycophenolate sodium

Nabumetone CEP

Naproxen CEP

Naproxen sodium CEP

Nateglinide

* TAPI can provide several different polymorphs or processes of this product.To obtain complete DMF files of a specific product's polymorph or process, please contact your account manager.

Additional DMFs or Tech Files are available upon request** Tech File relevant only for products prior to 1st DMF All subject to the disclaimer on the last page

Page 8: Product Name Tapi · PDF fileMethylergonovine maleate Methylprednisolone sodium succinate Micafungin sodium Mitomycin Mycophenolate mofetil Octreotide acetate

Product Name TapiIP

Tech File** USDMF

CEP EUDMF

JapanDMF

KoreaDMF

Nefazodone HCl

Nicergoline CEP

Nifedipine CEP

Nilotinib *

Nintedanib

Norgestimate

Obeticholic Acid

Octreotide acetate

Olanzapine CEP

Olmesartan medoxomil CEP

Olodaterol HCl

Omeprazole CEP

Ondansetron base

Ondansetron HCl CEP

Osimertinib mesylate

Oxaliplatin CEP

Paclitaxel CEP

Palbociclib

Paliperidone

Paliperidone palmitate

Palonosetron HCl *

Pamidronic acid

Pancuronium bromide CEP

Pantoprazole magnesium

Pantoprazole sodium CEP

Paricalcitol

Paroxetine HCl

Pemetrexed *

Perampanel

Pergolide mesylate CEP

Pioglitazone HCl

* TAPI can provide several different polymorphs or processes of this product.To obtain complete DMF files of a specific product's polymorph or process, please contact your account manager.

Additional DMFs or Tech Files are available upon request** Tech File relevant only for products prior to 1st DMF All subject to the disclaimer on the last page

Page 9: Product Name Tapi · PDF fileMethylergonovine maleate Methylprednisolone sodium succinate Micafungin sodium Mitomycin Mycophenolate mofetil Octreotide acetate

Product Name TapiIP

Tech File** USDMF

CEP EUDMF

JapanDMF

KoreaDMF

Plecanatide

Pralatrexate

Prasugrel base

Prasugrel HBr

Prasugrel HCl

Pravastatin sodium CEP

Prednisolone hemisuccinate

Pregabalin

Probenecid CEP

Quetiapine fumarate

Risedronate sodium

Risperidone CEP

Rivaroxaban

Rocuronium bromide CEP

Rolapitant

Romidepsin

Rosuvastatin calcium CEP

Rotigotine

Salbutamol (albuterol) base

Salbutamol (albuterol) sulfate CEP

Saxagliptin

Selexipag *

Sildenafil citrate CEP

Silver sulfadiazine

Silymarin * CEP

Simvastatin CEP

Sitagliptin malate

Sitagliptin phosphate *

Sofosbuvir *

Solifenacin succinate

Sorafenib

* TAPI can provide several different polymorphs or processes of this product.To obtain complete DMF files of a specific product's polymorph or process, please contact your account manager.

Additional DMFs or Tech Files are available upon request** Tech File relevant only for products prior to 1st DMF All subject to the disclaimer on the last page

Page 10: Product Name Tapi · PDF fileMethylergonovine maleate Methylprednisolone sodium succinate Micafungin sodium Mitomycin Mycophenolate mofetil Octreotide acetate

Product Name TapiIP

Tech File** USDMF

CEP EUDMF

JapanDMF

KoreaDMF

Sugammadex

Sunitinib *

Sunitinib malate *

Tacrolimus

Telmisartan CEP

Telotristat etiprate

Terazosin HCl * CEP

Terguride *

Ticagrelor

Tigecycline

Timolol maleate CEP

Tiotropium bromide *

Tobramycin CEP

Tolterodine tartrate

Torasemide CEP

Travoprost

Trazodone HCl

Triamcinolone

Triamcinolone acetonide CEP

Ulipristal acetate

Umeclidinum bromide

Valaciclovir HCl

Valbenazine tosylate

Valsartan Sacubitril

Vecuronium bromide

Venetoclax *

Venlafaxine HCl CEP

Vilanterol trifenatate

Vilazodone HCl

* TAPI can provide several different polymorphs or processes of this product.To obtain complete DMF files of a specific product's polymorph or process, please contact your account manager.

Additional DMFs or Tech Files are available upon request** Tech File relevant only for products prior to 1st DMF All subject to the disclaimer on the last page

Page 11: Product Name Tapi · PDF fileMethylergonovine maleate Methylprednisolone sodium succinate Micafungin sodium Mitomycin Mycophenolate mofetil Octreotide acetate

Product Name TapiIP

Tech File** USDMF

CEP EUDMF

JapanDMF

KoreaDMF

Warfarin sodium clathrate

Zaleplon

Zoledronic acid

Zolmitriptan

Zolpidem tartrate CEP

* TAPI can provide several different polymorphs or processes of this product.To obtain complete DMF files of a specific product's polymorph or process, please contact your account manager.

Additional DMFs or Tech Files are available upon request** Tech File relevant only for products prior to 1st DMF All subject to the disclaimer on the last page

Page 12: Product Name Tapi · PDF fileMethylergonovine maleate Methylprednisolone sodium succinate Micafungin sodium Mitomycin Mycophenolate mofetil Octreotide acetate

Portfolio for:

InhalationAztreonamBeclomethasone dipropionateBudesonideFlunisolideFluticasone furoateFluticasone propionateFormoterol fumarateLevosalbutamol HCl (levalbuterol)Mometasone furoateOlodaterol HClSalbutamol (albuterol) sulfateTiotropium bromideTobramycinTriamcinolone acetonideUmeclidinum bromideVilanterol trifenatate

InjectablesAbaloparatideAnidulafunginAtracurium besylateAzacitidineAzithromycin dihydrateAztreonamBetamethasone acetateBivalirudinBleomycin sulfateBortezomibBuprenorphine HClButorphanol tartrateCabazitaxelCalcitriolCarboplatinCarfilzomibCaspofungin acetateCiclosporinCisatracurium besylateCisplatin

Daunorubicin HClDeferoxamine mesylateDesmopressin acetateDexrazoxane (icrf)Dihydroergotamine mesylateDocetaxelDoxercalciferolDoxorubicin HClEpirubicin HClEptifibatideErgometrine (ergonovine) maleateEtoposideExenatideFludarabine phosphateFluorouracil - (5FU)FulvestrantGemcitabine HClHaloperidol decanoateIcatibantIdarubicin HClLabetalol HClLanreotide acetateLevofloxacinLinezolidMedroxyprogesterone acetateMethylergonovine maleateMethylprednisolone sodium succinateMicafungin sodiumMitomycinMycophenolate mofetilOctreotide acetateOndansetron HClOxaliplatinPaclitaxelPalonosetron HClPamidronic acidPancuronium bromidePantoprazole sodiumParicalcitolPemetrexed

Page 13: Product Name Tapi · PDF fileMethylergonovine maleate Methylprednisolone sodium succinate Micafungin sodium Mitomycin Mycophenolate mofetil Octreotide acetate

Portfolio for:

PralatrexateRisperidoneRocuronium bromideRolapitantRomidepsinSugammadexTacrolimusTigecyclineTobramycinVecuronium bromideWarfarin sodium clathrateZoledronic acid

NasalBeclomethasone dipropionateBudesonideButorphanol tartrateDesmopressin acetateDihydroergotamine mesylateFlunisolideFluticasone propionateMometasone furoateMupirocin calciumTriamcinolone acetonideZolmitriptan

OphtalmicAzithromycin dihydrateBimatoprostCiclosporinDifluprednateDorzolamide HClFluocinolone acetonideFluorometholone acetateFluorometholone baseLatanoprostLevofloxacinLifitegrastTacrolimusTimolol maleate

TobramycinTravoprost

OticBeclomethasone dipropionateBetamethasone acetateBetamethasone baseBetamethasone dipropionateBetamethasone valerateFluocinolone acetonideFluorometholone acetateFluorometholone baseTobramycinTriamcinolone acetonide

PeptidesAbaloparatideAtosiban AcetateBivalirudinDesmopressin acetateEptifibatideExenatideIcatibantLanreotide acetateLinaclotideOctreotide acetatePlecanatide

TopicalAcyclovirAlclometasone dipropionateAmcinonideBetamethasone dipropionateBetamethasone valerateCalcipotrieneCalcitriolCiclosporinClobetasol propionateCrisaboroleDesonide

Page 14: Product Name Tapi · PDF fileMethylergonovine maleate Methylprednisolone sodium succinate Micafungin sodium Mitomycin Mycophenolate mofetil Octreotide acetate

Portfolio for:

Dexamethasone -17 valerateDiflorasone diacetateDifluprednateDoxepin HClFluocinolone acetonideFluocinonideFluorouracil - (5FU)Fluticasone propionateImiquimodMitomycinMometasone furoateMupirocinMupirocin calciumSilver sulfadiazineSilymarinTacrolimusTriamcinolone acetonide

VeterinaryBeclomethasone dipropionateBetamethasone acetateBetamethasone dipropionateBetamethasone valerateBromocriptine mesylateBudesonideBuprenorphine baseButorphanol tartrateCabergolineCiclosporinClobetasol propionateErgometrine (ergonovine) maleateEtodolacFluocinolone acetonideFluocinonideFluoxetine HClFurosemideHydrochlorothiazideMegestrol acetateMometasone furoateMupirocin

Mycophenolate mofetilNaproxenNicergolineOmeprazolePaclitaxelPergolide mesylatePrednisolone hemisuccinateSalbutamol (albuterol) sulfateTacrolimusTriamcinoloneTriamcinolone acetonide

Page 15: Product Name Tapi · PDF fileMethylergonovine maleate Methylprednisolone sodium succinate Micafungin sodium Mitomycin Mycophenolate mofetil Octreotide acetate

Regional Sales OfficesChinaTAPI InternationalRoom 1209, North Ring Center18th Yumin RoadXicheng DistrictBeijing 100029, ChinaTel: +86 10 83162606Fax: +86 10 51410728

EuropeTeva API B.V.,Piet Hein Building,Piet Heinkade 107, 1019 GMAmsterdam, The NetherlandsTel: +31 20 2193 222Fax: +31 20 2193 297

Indian SubcontinentTeva Pharmaceutical & ChemicalIndustries India Pvt. Ltd.601, Omega, Hiranandani GardensMain Street Powai,Mumbai 400 076, IndiaTel: +91 22 2570 5681/82Fax: +91 22 2570 5684

IsraelTeva Pharmaceutical Industries Ltd.5 Basel St., PO Box 3190,Petach Tikva 4951033 IsraelTel: +972 3 9267267Fax: +972 3 9234050

JapanTeva API Japan, Ltd.Metro City Kamiyacho Bldg. 7F5-1-5, Toranomon, Minato-kuTokyo 105-0001 JAPANTel: +81-3-5404-8441Fax: +81-3-5404-8442

Latin AmericaTAPI InternationalRua James Joule, 92-15o andarCEP 04576-080 - São Paulo - SP - BrazilTel./Fax. +55 11 5506 8670

North AmericaTeva API Inc.400 Interpace ParkwayMorris Corporate Center IIIParsippany, NJ 07054Tel: 973-265-3600Fax: 973-265-3681

Page 16: Product Name Tapi · PDF fileMethylergonovine maleate Methylprednisolone sodium succinate Micafungin sodium Mitomycin Mycophenolate mofetil Octreotide acetate

Manufacturing & R&D Sites * Formal legal entity

IsraelAssia Chemical Industries Ltd.*Manufacturing site: Teva TechNeot-Hovav Eco-Industrial Park, Emek SaraP.O. Box 2049Beer Sheva, 8412316, Israel

Plantex Ltd.*1 Hakadar st., Industrial ZoneP.O.Box 160Netanya, 4210101, Israel

Abic Ltd.*Kiryat Sapir Industrial ZoneP.O.Box 8077Netanya, 4250483, Israel

North and Central AmericaTAPI Puerto Rico Inc.*Guayama siteState road # 3, km 143.0Guayama, Puerto Rico 00784, USA

Humacao siteIndustrial Park Hwy 3Km. 76.3Humacao, Puerto Rico 00741, USA

Teva Pharmaceuticals USA, Inc.*Missouri site5000 Snyder DriveMexico, Missouri 65265, USA

Sicor de México S.A. de C.V.*Av. San Rafael no. 35Parque Industrial Lerma52000, Lerma Estado de Mexico, Mexico

AsiaTeva API India Limited*Gajraula sitePlot Nos. A-2, A-2/1 & A-2/2

UPSIDC Industrial Area

Bijnor Road, Distt. J.P. Nagar

Gajraula-244 235 (Uttar Pradesh), India

Malanpur siteQ1 to Q4 Industrial Area, GhirongiMalanpur, Distt: Bhind (Madhya Pradesh), India

Teva Pharmaceutical & Chemical(Hangzhou) Co. Ltd.*No.1889, Jingliu Road, Linjiang Industrial Zone, XiaoshanHangzhou, 311228 China

TAPI India Ambernath21-22, Kalpataru Square, Kondivita Lane, Off Andheri KurlaRoad.Andheri (E), Mumbai 400059, India

EuropeTeva Czech Industries s.r.o*Ostravska 29/305,747 70 Opava – KomarovCzech Republic

Sicor - Società Italiana Corticosteroidi S.r.l*Bulciago siteVia Briantea km 36 n. 8323892, Bulciago (LC), ItalyVillanterio siteVia Statale no. 235, km 16,88027019, Villanterio (PV), ItalyCaronno siteVia Enrico. Fermi 52021042 Caronno Pertusella (VA), ItalyRho siteVia Terazzano 7720017, Rho (MI), ItalySanthià siteTenuta S. Alesandro13048, Santhià (VC), Italy

Teva Pharmaceutical Works Ltd.*Debrecen site13 Pallagi St.Debrecen, H-4042, HungarySajobabony siteVegyipari Park (Industrial Area)Sajobabony, H-3792,P.O.Box 6, Hungary

PLIVA Hrvatska d.o.o.*Savski Marof (SM) sitePrudnicka Cesta 5410291 Prigorje Brdovecko, Croatia

PbF sitePrilaz Baruna Filipovica 2510000 Zagreb, Croatia

Coleraine189 Castleroe RoadColeraine BT51 3RP

Page 17: Product Name Tapi · PDF fileMethylergonovine maleate Methylprednisolone sodium succinate Micafungin sodium Mitomycin Mycophenolate mofetil Octreotide acetate

Disclaimer

The information contained herein is the proprietary information of TEVAPHARMACEUTICAL INDUSTRIES LTD.and its affiliates. This information isprovided to you solely for your evaluation, to determine your interest in a potentialbusiness relationship (the “Business Purpose”) with TEVA PHARMACEUTICALINDUSTRIES LTD and/or its affiliates. As a condition of receiving this information,including, but not limited to verbal information, you are obligated to maintainconfidentiality about the information and not use it beyond the Business Purpose.No representations or guarantees whatsoever are intended to be given by TEVAPHARMACEUTICAL INDUSTRIES LTD. Teva makes no warranty as to thecompleteness or accuracy of the information provided herein.

Furthermore, no information in this catalog - including any reference to anyproduct or service - constitutes an offer for sale, or be construed as representingan offer for sale. In particular, nothing in this catalog should be construed as apromotion or advertisement for any product, or for the use of any product, thatinfringes valid patents and/or is not authorized by the laws and regulations ofyour country of residence.

Page 18: Product Name Tapi · PDF fileMethylergonovine maleate Methylprednisolone sodium succinate Micafungin sodium Mitomycin Mycophenolate mofetil Octreotide acetate