Suppliers / Zentiva, k.s

Zentiva, k.s

Czech Republic Updated 9 July 2026

Zentiva, k.s is an API and finished-dose manufacturer based in Czech Republic. It appears in 6,928 regulatory filings across 17 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), EMA and MHRA (UK). Its GMP standing is certified by MHRA (UK), CDSCO (India) and EAEU_EEC, among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 13 February 2025 as NAI.

0
active US DMFs
0
valid CEPs
6
registered plants 1 with an FDA FEI number
6,928
filings across 17 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 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

  • 13 February 2025 NAI US FDA
  • 7 February 2019 NAI US FDA
  • 1 July 2016 VAI US FDA
  • 19 May 2012 NAI US FDA
  • 4 September 2009 VAI US FDA

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

Registered plants

Site FDA FEI
SUTTON-IN-ASHFIELD, United Kingdom Not on file
SUTTON-IN-ASHFIELD, United Kingdom Not on file
GUILDFORD, United Kingdom Not on file
Ankleshwar, India Not on file
Ankleshwar, India 3004086396
ankleshwar 393 002bharuch, India Not on file

What they file, and where

Molecule Regulators Docs
Tetryzoline SFDA (Saudi Arabia) 1

Also appears on these molecule pages

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Alprazolam finished dose Ambrisentan finished dose Ambroxol finished dose Amiodarone finished dose Amisulpride finished dose Amlodipine finished dose Amoxicillin finished dose 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 Atropine finished dose Azacitidine finished dose Azelastine finished dose Azithromycin finished dose Baclofen finished dose Beclomethasone finished dose Bendamustine finished dose Benzoyl Peroxide finished dose Betahistine finished dose Betamethasone finished dose Bicalutamide finished dose Bilastine finished dose Bimatoprost finished dose Bisacodyl finished dose Bisoprolol finished dose Bortezomib finished dose Bosentan finished dose Bosutinib finished dose Brimonidine finished dose Brinzolamide finished dose Brivaracetam finished dose Budesonide finished dose Buprenorphine finished dose Bupropion finished dose Busulfan finished dose Cabazitaxel finished dose Caffeine 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 Carglumic Acid finished dose Carmustine finished dose Carvedilol finished dose Caspofungin finished dose Cefpodoxime finished dose Ceftriaxone finished dose Cefuroxime finished dose Cefuroxime Axetil finished dose Celecoxib finished dose Cetirizine finished dose Chlorphenamine finished dose Chlorpheniramine finished dose Ciclesonide finished dose Ciclopirox finished dose Ciclopirox Olamine finished dose Cinacalcet finished dose Ciprofibrate finished dose Ciprofloxacin finished dose Citalopram finished dose Clarithromycin finished dose Clavulanic Acid finished dose Clofarabine finished dose Clopidogrel finished dose Cloxacillin finished dose Clozapine finished dose Cobicistat finished dose Codeine finished dose Colchicine finished dose Colesevelam finished dose Dabigatran Etexilate finished dose Dabigatran Etexilate Mesilate finished dose Dalbavancin finished dose Dalfampridine finished dose Dapsone finished dose Daptomycin finished dose Darunavir finished dose Dasatinib finished dose Daunorubicin finished dose Deferasirox finished dose Desloratadine finished dose Desmopressin finished dose Desogestrel finished dose Dexpanthenol finished dose Diacerein finished dose Diazepam finished dose Dienogest finished dose Diltiazem finished dose Dimethyl finished dose Diosmin finished dose Docetaxel finished dose Dolutegravir finished dose Domperidone finished dose Donepezil finished dose Dorzolamide finished dose Doxazosin finished dose Doxazosin Mesilate finished dose Doxepin finished dose Doxylamine finished dose Drospirenone finished dose Duloxetine finished dose Dutasteride finished dose Ebastine finished dose Econazole finished dose Edoxaban finished dose Efavirenz finished dose Eletriptan finished dose Eltrombopag finished dose Elvitegravir finished dose Empagliflozin finished dose Emtricitabine finished dose Enalapril finished dose Enoxaparin finished dose Entecavir finished dose Enzalutamide finished dose Eplerenone finished dose Eribulin finished dose Erlotinib finished dose Escitalopram finished dose Eslicarbazepine finished dose Esomeprazole finished dose Ethinylestradiol finished dose Etonogestrel finished dose Etoricoxib finished dose Everolimus finished dose Exemestane finished dose Ezetimibe finished dose Febuxostat finished dose Felodipine finished dose Fenofibrate finished dose Fentanyl finished dose Fesoterodine finished dose Fexofenadine finished dose Finasteride finished dose Fingolimod finished dose Flecainide finished dose Fluconazole finished dose Fluoxetine finished dose Flurbiprofen finished dose Fluticasone finished dose Fluvastatin finished dose Formoterol finished dose Fosaprepitant finished dose Fosfomycin finished dose Fulvestrant finished dose Furosemide finished dose Fusidic Acid finished dose Gabapentin finished dose Galantamine finished dose Gefitinib finished dose Gentamicin finished dose Glatiramer finished dose Gliclazide finished dose Glimepiride finished dose Glycopyrronium finished dose Hesperidin finished dose Hydrochlorothiazide finished dose Hydrocortisone finished dose Hydroxychloroquine finished dose Hydroxyzine finished dose Ibandronate finished dose Ibandronic Acid finished dose Ibuprofen finished dose Icatibant finished dose Iloprost finished dose Imatinib finished dose Imatinib Mesilate finished dose Indapamide finished dose Iohexol finished dose Ipratropium finished dose Irbesartan finished dose Ivabradine finished dose Ivacaftor finished dose Ivermectin finished dose Ketoconazole finished dose Ketoprofen finished dose Lacosamide finished dose Lactulose finished dose Lamivudine finished dose Lamotrigine finished dose Lanreotide finished dose Lansoprazole finished dose Latanoprost finished dose Leflunomide finished dose Lenalidomide finished dose Lercanidipine finished dose Letrozole finished dose Leucovorin finished dose Leuprolide finished dose Levetiracetam finished dose Levocetirizine finished dose Levodopa finished dose Levodropropizine finished dose Levofloxacin finished dose Levonorgestrel finished dose Levothyroxine finished dose Lidocaine finished dose Linagliptin finished dose Linezolid finished dose Lipoic Acid finished dose Liraglutide finished dose Lisinopril finished dose Loperamide finished dose Loratadine finished dose Lorazepam finished dose Losartan finished dose Macitentan finished dose Megestrol finished dose Meloxicam finished dose Melphalan finished dose Memantine finished dose Metformin finished dose Methenamine finished dose Methylphenidate finished dose Metoprolol finished dose Metronidazole finished dose Midodrine finished dose Mirabegron finished dose Mirtazapine finished dose Modafinil finished dose Mometasone finished dose Montelukast finished dose Naloxone finished dose Nebivolol finished dose Nilotinib finished dose Nintedanib finished dose Nitroglycerin finished dose Norepinephrine finished dose Ofloxacin finished dose Olanzapine finished dose Olmesartan Medoxomil finished dose Olopatadine finished dose Omeprazole finished dose Ondansetron finished dose Oseltamivir finished dose Oxycodone finished dose Paclitaxel finished dose Paliperidone finished dose Pantoprazole finished dose Paracetamol finished dose Paroxetine finished dose Pazopanib finished dose Pemetrexed finished dose Pemetrexed Disodium Hemipentahydrate finished dose Pentoxifylline finished dose Perindopril finished dose Perindopril Tert-Butylamine finished dose Phloroglucinol finished dose Pioglitazone finished dose Pirfenidone finished dose Plerixafor finished dose Pomalidomide finished dose Posaconazole finished dose Pramipexole finished dose Prasugrel finished dose Pravastatin finished dose Prednisolone finished dose Prednisone finished dose Pregabalin finished dose Prilocaine finished dose Progesterone finished dose Prucalopride finished dose Pseudoephedrine finished dose Quetiapine finished dose Quinapril finished dose Rabeprazole finished dose Racecadotril finished dose Raloxifene finished dose Raltegravir finished dose Ramipril finished dose Ranitidine finished dose Ranolazine finished dose Rasagiline finished dose Repaglinide finished dose Riluzole finished dose Risedronic Acid finished dose Risperidone finished dose Rivaroxaban finished dose Rivastigmine finished dose Rizatriptan finished dose Ropinirole finished dose Rosuvastatin finished dose Roxithromycin finished dose Rupatadine finished dose Sacubitril finished dose Salmeterol finished dose Saxagliptin finished dose Sertraline 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 Spiramycin finished dose Spironolactone finished dose Sugammadex finished dose Sulpiride finished dose Sumatriptan finished dose Sunitinib finished dose Tadalafil finished dose Tamsulosin finished dose Tapentadol finished dose Telmisartan finished dose Temozolomide finished dose Tenofovir Alafenamide finished dose Tenofovir Disoproxil finished dose Terazosin finished dose Terbinafine finished dose Teriflunomide finished dose Terlipressin finished dose Tetrabenazine finished dose Tetryzoline API Thiocolchicoside finished dose Ticagrelor finished dose Tigecycline finished dose Timolol finished dose Tiotropium finished dose Tobramycin finished dose Tolterodine finished dose Tolvaptan finished dose Torasemide finished dose Tranexamic Acid finished dose Travoprost finished dose Trazodone finished dose Treprostinil finished dose Trimebutine finished dose Ulipristal finished dose Valganciclovir finished dose Valsartan finished dose Vancomycin finished dose Vardenafil finished dose Varenicline finished dose Venlafaxine finished dose Vildagliptin finished dose Voriconazole finished dose Warfarin finished dose Xylometazoline finished dose Zoledronic Acid finished dose Zolmitriptan finished dose Zolpidem finished dose Zopiclone finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 3,490 None
EMA 1,060 2
MHRA (UK) 743 6
ANSM (FR) 580 None
MPA (SE) 313 None
FAMHP (BE) 210 None
CDSCO (India) None 2
EAEU_EEC None 2
MINPROMTORG (RU) None 1
US FDA None 1

Questions about Zentiva, k.s

Does Zentiva, k.s hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Zentiva, k.s. It does have 6,928 filings with 17 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Zentiva, k.s FDA-registered?
One site operated by Zentiva, k.s carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Zentiva, k.s's last inspection go?
The most recent inspection on record closed on 13 February 2025 as NAI (No Action Indicated: nothing objectionable was found). 5 inspections are on file.
Where does Zentiva, k.s manufacture?
6 registered sites are on record, in United Kingdom and India (Sutton-in-ashfield, Guildford and Ankleshwar among others). Every site is listed on this page with the register it came from.
What does Zentiva, k.s make?
1 molecule is on record against Zentiva, k.s, including Tetryzoline. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zentiva, k.s's GMP?
Current GMP certificates are on record from MHRA (UK), CDSCO (India), EEC (Eurasian Economic Union), EMA, MINPROMTORG (RU) and 1 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 NAI, on 13 February 2025.

Comparable suppliers

Societa Italiana Medicinali Scandicci Sims shares 1 molecule S.I.M.S. Italy - Società Italiana Medicinali Scandicci shares 1 molecule Glenmark Pharmaceuticals s.r.o also in Czech Republic Oncomed Manufacturing also in Czech Republic "PRO.MED.CS Praha also in Czech Republic

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