Suppliers / Sandoz

Sandoz

Switzerland 26 employees reconciled across 275 public records · 40 entities Updated 9 July 2026

Sandoz is an API and finished-dose manufacturer based in Switzerland. It holds 40 active US drug master files and 20 valid CEPs. Its filings concentrate with AIFA (IT), Health Canada and EMA. Its GMP standing is certified by EMA, COFEPRIS (MX) and ANSM (FR), among 15 authorities. Its most recent recorded inspection, by US FDA, closed on 2 July 2024 as VAI. Customs aggregates show $188.6M of exports covering 2,928 molecules to 48 destinations in 2025.

40
active US DMFs
20
valid CEPs
37
registered plants 4 with an FDA FEI number
23,070
filings across 49 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
4 of 8 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 2 July 2024 VAI US FDA
  • 17 November 2023 VAI US FDA
  • 11 July 2022 VAI US FDA
  • 27 February 2020 VAI US FDA
  • 12 April 2019 VAI US FDA
  • 18 September 2018 VAI US FDA
  • 3 March 2017 VAI US FDA
  • 17 November 2016 VAI US FDA
  • 5 July 2016 VAI US FDA
  • 29 January 2016 VAI US FDA
  • 30 April 2015 VAI US FDA
  • 16 September 2014 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Targu Mures, United Arab Emirates Not on file
Kundl, United Arab Emirates Not on file
Kundl, United Arab Emirates Not on file
Kundl, United Arab Emirates Not on file
Targu Mures, United Arab Emirates Not on file
KUNDL, Austria Not on file

31 further sites are on record.

What they file, and where

Molecule Regulators Docs
Ampicillin US FDA 6
Amoxicillin SFDA (Saudi Arabia), US FDA 5
Cefpodoxime Proxetil EDQM, SFDA (Saudi Arabia) 5
Ceftriaxone EDQM, US FDA 4
Benzylpenicillin EDQM, US FDA 3
Cefazolin EDQM, US FDA 3
Cefixime EDQM, US FDA 3
Ceftazidime EDQM, US FDA 3
Potassium Clavulanate SFDA (Saudi Arabia) 3
Amoxicillin Sodium EDQM 2
Show all 33 molecules on file
Ampicillin Sodium EDQM 2
Aripiprazole SFDA (Saudi Arabia) 2
Benzylpenicillin (Procaine) Monohydrate EDQM 2
Cefdinir US FDA 2
Cefotaxime US FDA 2
Cefpodoxime US FDA 2
Cephalosporin C US FDA 2
Clarithromycin SFDA (Saudi Arabia) 2
Heparin Sodium US FDA 2
Levothyroxine US FDA 2
Phenoxymethylpenicillin US FDA 2
Piperacillin US FDA 2
Quetiapine SFDA (Saudi Arabia) 2
Temsirolimus US FDA 2
Amoxicillin Trihydrate EDQM 1
Benzylpenicillin (Benzathine) Tetrahydrate EDQM 1
Benzylpenicillin Sodium EDQM 1
Ceftazidime Pentahydrate With Sodium Carbonate For Injection EDQM 1
Clofazimine US FDA 1
Cloxacillin US FDA 1
Levothyroxine Sodium EDQM 1
Phenoxymethylpenicillin (Benzathine) Tetrahydrate EDQM 1
Phenoxymethylpenicillin Potassium EDQM 1

Also appears on these molecule pages

Abacavir finished dose Abiraterone finished dose Acarbose finished dose Acetylcysteine finished dose Acyclovir finished dose Alendronic Acid finished dose Alfuzosin finished dose Allopurinol finished dose Alprazolam finished dose Amantadine finished dose Ambrisentan finished dose Amiodarone finished dose
Show 378 more molecule pages
Amisulpride finished dose Amitriptyline finished dose Amoxicillin API Ampicillin API Anagrelide finished dose Anastrozole finished dose Apixaban finished dose Apremilast finished dose Aprepitant finished dose Aripiprazole finished dose Atazanavir finished dose Atenolol finished dose Atomoxetine finished dose Atorvastatin finished dose Axitinib finished dose Azacitidine finished dose Azathioprine finished dose Azelaic Acid finished dose Azelastine finished dose Azithromycin finished dose Benzylpenicillin API Betahistine finished dose Betamethasone finished dose Bicalutamide finished dose Bimatoprost finished dose Bisacodyl finished dose Bisoprolol finished dose Bosentan finished dose Bosutinib finished dose Brexpiprazole finished dose Brimonidine finished dose Brinzolamide finished dose Budesonide finished dose Bupivacaine finished dose Buprenorphine finished dose Bupropion finished dose Buspirone finished dose Cabazitaxel finished dose Calcipotriol finished dose Calcium Carbonate finished dose Calcium Folinate finished dose Candesartan finished dose Candesartan Cilexetil finished dose Capecitabine finished dose Captopril finished dose Carbamazepine finished dose Carbidopa finished dose Carbocisteine finished dose Carisoprodol finished dose Carmustine finished dose Carvedilol finished dose Caspofungin finished dose Cefadroxil finished dose Cefazolin API Cefdinir API Cefixime API Cefotaxime API Cefpodoxime API Cefprozil finished dose Ceftazidime API Ceftriaxone API Cefuroxime finished dose Cefuroxime Axetil finished dose Celecoxib finished dose Cephalexin finished dose Cetirizine finished dose Chlorothiazide finished dose Chlorpromazine finished dose Chlorthalidone finished dose Ciclesonide finished dose Ciclopirox finished dose Ciclopirox Olamine finished dose Ciclosporin finished dose Cimetidine finished dose Cinacalcet finished dose Ciprofloxacin finished dose Cisatracurium finished dose Cisplatin finished dose Citalopram finished dose Clarithromycin finished dose Clavulanic Acid finished dose Clomipramine finished dose Clonazepam finished dose Clopidogrel finished dose Cloxacillin finished dose Clozapine finished dose Cobicistat finished dose Colchicine finished dose Cyclobenzaprine finished dose Cyclophosphamide finished dose Cyclosporine finished dose Cytarabine finished dose Dabigatran Etexilate finished dose Dabigatran Etexilate Mesilate finished dose Dalfampridine finished dose Dapagliflozin finished dose Darunavir finished dose Dasatinib finished dose Decitabine finished dose Deferasirox finished dose Desloratadine finished dose Desmopressin finished dose Desogestrel finished dose Dexamethasone finished dose Dexpanthenol finished dose Dextroamphetamine finished dose Diclofenac finished dose Dimethyl finished dose Diosmin finished dose Dipyridamole finished dose Docetaxel finished dose Dolutegravir finished dose Donepezil finished dose Dorzolamide finished dose Doxazosin finished dose Doxepin finished dose Doxercalciferol finished dose Doxycycline finished dose Doxylamine finished dose Duloxetine finished dose Dutasteride finished dose Ebastine finished dose Econazole finished dose Edaravone finished dose Edoxaban finished dose Efavirenz finished dose Eltrombopag finished dose Elvitegravir finished dose Emtricitabine finished dose Enalapril finished dose Enoxaparin finished dose Entacapone finished dose Entecavir finished dose Enzalutamide finished dose Eplerenone finished dose Eribulin finished dose Erlotinib finished dose Escitalopram finished dose Esomeprazole finished dose Estradiol finished dose Ethinylestradiol finished dose Etodolac finished dose Etoricoxib finished dose Everolimus finished dose Exemestane finished dose Ezetimibe finished dose Febuxostat finished dose Felodipine finished dose Fentanyl finished dose Ferric Carboxymaltose finished dose Finasteride finished dose Fingolimod finished dose Flecainide finished dose Fluconazole finished dose Flumazenil finished dose Fluorometholone finished dose Fluorouracil finished dose Fluoxetine finished dose Fluphenazine finished dose Fluticasone finished dose Fluvastatin finished dose Fluvoxamine finished dose Fondaparinux finished dose Formoterol finished dose Fosfomycin finished dose Fulvestrant finished dose Furosemide finished dose Fusidic Acid finished dose Gabapentin finished dose Galantamine finished dose Ganciclovir finished dose Gatifloxacin finished dose Gefitinib finished dose Gemcitabine finished dose Gliclazide finished dose Glimepiride finished dose Granisetron finished dose Guanfacine finished dose Heparin API Hesperidin finished dose Hydralazine finished dose Hydrocortisone finished dose Hydroxychloroquine finished dose Hydroxyzine finished dose Ibandronate finished dose Ibandronic Acid finished dose Icatibant finished dose Imatinib finished dose Imatinib Mesilate finished dose Indapamide finished dose Irbesartan finished dose Isoniazid finished dose Itraconazole finished dose Ivabradine finished dose Ivermectin finished dose Ketoconazole finished dose Ketoprofen finished dose Lactulose finished dose Lamivudine finished dose Lansoprazole finished dose Latanoprost finished dose Leflunomide finished dose Lenalidomide finished dose Lenvatinib finished dose Lercanidipine finished dose Letrozole finished dose Leucovorin finished dose Leuprolide finished dose Levetiracetam finished dose Levocetirizine finished dose Levofloxacin finished dose Levonorgestrel finished dose Levothyroxine API Linagliptin finished dose Linezolid finished dose Lisinopril finished dose Loperamide finished dose Loratadine finished dose Losartan finished dose Macitentan finished dose Meclizine finished dose Memantine finished dose Mepivacaine finished dose Meprobamate finished dose Meropenem finished dose Metaxalone finished dose Metformin finished dose Methadone finished dose Methimazole finished dose Methocarbamol finished dose Methylphenidate finished dose Methylprednisolone finished dose Metoclopramide finished dose Metoprolol finished dose Micafungin finished dose Minocycline finished dose Minoxidil finished dose Mirtazapine finished dose Mometasone finished dose Montelukast finished dose Moxifloxacin finished dose Mycophenolate Mofetil finished dose Mycophenolic Acid finished dose Nadolol finished dose Naftifine finished dose Naproxen finished dose Nebivolol finished dose Nelarabine finished dose Neomycin finished dose Nevirapine finished dose Nifedipine finished dose Nintedanib finished dose Nitroglycerin finished dose Octreotide finished dose Ofloxacin finished dose Olanzapine finished dose Olmesartan Medoxomil finished dose Omeprazole finished dose Ondansetron finished dose Orlistat finished dose Oxacillin finished dose Oxandrolone finished dose Oxcarbazepine finished dose Oxycodone finished dose Oxytocin finished dose Paclitaxel finished dose Palonosetron finished dose Pantoprazole finished dose Paricalcitol finished dose Paroxetine finished dose Pemetrexed finished dose Pemetrexed Disodium finished dose Pemetrexed Disodium Hemipentahydrate finished dose Perindopril finished dose Perindopril Tert-Butylamine finished dose Phentermine finished dose Phenylephrine finished dose Phylloquinone finished dose Piperacillin finished dose Pirfenidone finished dose Pomalidomide finished dose Posaconazole finished dose Potassium Clavulanate finished dose Pramipexole finished dose Pravastatin finished dose Prednisone finished dose Pregabalin finished dose Promethazine finished dose Propranolol finished dose Prucalopride finished dose Pseudoephedrine finished dose Pyrazinamide finished dose Pyridostigmine finished dose Quinapril finished dose Rabeprazole finished dose Raloxifene finished dose Ramipril finished dose Rasagiline finished dose Repaglinide finished dose Ribavirin finished dose Ribociclib finished dose Rifampicin finished dose Rifampin finished dose Riluzole finished dose Risedronic Acid finished dose Risperidone finished dose Rivaroxaban finished dose Rivastigmine finished dose Rizatriptan finished dose Rocuronium finished dose Ropinirole finished dose Ropivacaine finished dose Rosuvastatin finished dose Roxithromycin finished dose Sacubitril finished dose Salmeterol finished dose Sertraline finished dose Sevelamer finished dose Sevoflurane finished dose Sildenafil finished dose Silodosin finished dose Simvastatin finished dose Sitagliptin finished dose Sodium Alendronate finished dose Solifenacin finished dose Sorafenib finished dose Sotalol finished dose Spironolactone finished dose Sugammadex finished dose Sulbactam finished dose Sulpiride finished dose Sumatriptan finished dose Sunitinib finished dose Tacrolimus finished dose Tafluprost finished dose Tamoxifen finished dose Tamsulosin finished dose Tazobactam finished dose Teicoplanin finished dose Telmisartan finished dose Temozolomide finished dose Tenofovir Disoproxil finished dose Terazosin finished dose Terbinafine finished dose Teriflunomide finished dose Theophylline finished dose Ticagrelor finished dose Tigecycline finished dose Timolol finished dose Tizanidine finished dose Tolterodine finished dose Tolvaptan finished dose Topiramate finished dose Torasemide finished dose Tramadol finished dose Travoprost finished dose Triamcinolone finished dose Trifluridine finished dose Trimebutine finished dose Ulipristal finished dose Valaciclovir finished dose Valacyclovir finished dose Valganciclovir finished dose Valsartan finished dose Vancomycin finished dose Vardenafil finished dose Venlafaxine finished dose Verapamil finished dose Vildagliptin finished dose Vinorelbine finished dose Voriconazole finished dose Ziprasidone finished dose Zoledronic Acid finished dose Zolmitriptan finished dose Zolpidem finished dose Zonisamide finished dose Zopiclone finished dose Quetiapine API

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 9,056 None
Health Canada 4,434 None
EMA 2,747 26
SWISSMEDIC (CH) 2,580 None
FAMHP (BE) 1,789 None
AEMPS (ES) 1,479 1
COFEPRIS (MX) None 8
ANSM (FR) None 6
HSA (SG) None 6
MHRA (UK) None 6
NCELS (KZ) None 5
EAEU_EEC None 5
ANVISA (Brazil) None 4
MFDS (Korea) None 4
NSW_HEALTH None 4
NAFDAC (NG) None 4
US FDA None 3
TMDA (TZ) None 2
FDA (GH) None 2

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $16.5M 30
2025 Not reported $188.6M 48
2024 Not reported $159.7M 52
2023 Not reported $179.2M 54

Export figures are customs aggregates. We do not publish the identity of any buyer.

Questions about Sandoz

Does Sandoz hold a US DMF or a CEP?
Sandoz holds 40 active US drug master files and 20 valid CEPs. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Sandoz FDA-registered?
4 sites operated by Sandoz carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Sandoz's last inspection go?
The most recent inspection on record closed on 2 July 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 20 inspections are on file, of which 1 closed as OAI.
Where does Sandoz manufacture?
37 registered sites are on record, in United Arab Emirates, Austria, Brazil and Canada (Targu Mures, Kundl and Kundl among others). Every site is listed on this page with the register it came from.
What does Sandoz make?
33 molecules are on record against Sandoz, including Ampicillin, Amoxicillin, Cefpodoxime Proxetil and Ceftriaxone. Each links through to that molecule's full manufacturer list.
Which regulators recognise Sandoz's GMP?
Current GMP certificates are on record from EMA, COFEPRIS (MX), ANSM (FR), HSA (SG), MHRA (UK) and 10 more. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was VAI, on 2 July 2024.

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates
Customs aggregates
Export values, molecule and destination counts