Suppliers / Glenmark Pharmaceuticals s.r.o

Glenmark Pharmaceuticals s.r.o

Czech Republic 970 employees Updated 9 July 2026

Glenmark Pharmaceuticals s.r.o is an API and finished-dose manufacturer based in Czech Republic. It appears in 2,751 regulatory filings across 40 regulators, without an active US DMF or CEP on file. Its filings concentrate with MHRA (UK), EMA and US FDA. Its GMP standing is certified by EMA, CDSCO (India) and ANVISA (Brazil), among 11 authorities. Its most recent recorded inspection, by US FDA, closed on 20 September 2024 as NAI.

0
active US DMFs
0
valid CEPs
12
registered plants
2,751
filings across 40 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
0 of 8 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 20 September 2024 NAI US FDA
  • 15 December 2023 NAI US FDA
  • 22 June 2022 OAI US FDA
  • 20 May 2022 OAI US FDA
  • 19 May 2022 OAI US FDA
  • 25 February 2020 NAI US FDA
  • 21 February 2020 NAI US FDA
  • 13 September 2019 NAI US FDA

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

Registered plants

Site FDA FEI
Nasik, United Arab Emirates Not on file
Tehsil Baddi, United Arab Emirates Not on file
Goa, United Arab Emirates Not on file
Himachal Pradesh, United Arab Emirates Not on file
Parque industrial De Pilar, United Arab Emirates Not on file
SAO PAULO, Brazil Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Lornoxicam SFDA (Saudi Arabia) 4
Desloratadine SFDA (Saudi Arabia) 3
Adapalene SFDA (Saudi Arabia) 2
Apremilast SFDA (Saudi Arabia) 2
Deferasirox SFDA (Saudi Arabia) 2
Glimepiride SFDA (Saudi Arabia) 2
Perindopril SFDA (Saudi Arabia) 2
Sitagliptin SFDA (Saudi Arabia) 2
Apixaban SFDA (Saudi Arabia) 1
Atovaquone SFDA (Saudi Arabia) 1
Show all 27 molecules on file
Esomeprazole SFDA (Saudi Arabia) 1
Etoricoxib SFDA (Saudi Arabia) 1
Ezetimibe SFDA (Saudi Arabia) 1
Fluconazole SFDA (Saudi Arabia) 1
Lurasidone SFDA (Saudi Arabia) 1
Nintedanib SFDA (Saudi Arabia) 1
Olmesartan Medoxomil SFDA (Saudi Arabia) 1
Perindopril Erbumine SFDA (Saudi Arabia) 1
Perindopril-Tert-Butylamine SFDA (Saudi Arabia) 1
Rasagiline SFDA (Saudi Arabia) 1
Rosuvastatin SFDA (Saudi Arabia) 1
Tazarotene SFDA (Saudi Arabia) 1
Telmisartan SFDA (Saudi Arabia) 1
Ticagrelor SFDA (Saudi Arabia) 1
Tofacitinib SFDA (Saudi Arabia) 1
Vildagliptin SFDA (Saudi Arabia) 1
Voriconazole SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Abiraterone finished dose Acarbose finished dose Acetaminophen finished dose Acetylcysteine finished dose Acetylsalicylic Acid finished dose Adapalene API Albuterol finished dose Ambroxol finished dose Amlodipine finished dose Amoxicillin finished dose Amphetamine finished dose Anagrelide finished dose
Show 268 more molecule pages
Anastrozole finished dose Apixaban API Apremilast API Arformoterol finished dose Aripiprazole finished dose Atomoxetine finished dose Atovaquone API Axitinib finished dose Azacitidine finished dose Azathioprine finished dose Azelaic Acid finished dose Azelastine finished dose Beclomethasone finished dose Bendamustine finished dose Benzocaine finished dose Benzoyl Peroxide finished dose Betamethasone finished dose Bezafibrate finished dose Bicalutamide finished dose Bilastine finished dose Bortezomib finished dose Brimonidine finished dose Brivaracetam finished dose Bromhexine finished dose Budesonide finished dose Buprenorphine finished dose Cabazitaxel finished dose Caffeine finished dose Calcipotriol finished dose Calcium Carbonate finished dose Capecitabine finished dose Carbocisteine finished dose Carboplatin finished dose Carfilzomib finished dose Carisoprodol finished dose Caspofungin finished dose Cefdinir finished dose Cefuroxime finished dose Cefuroxime Axetil finished dose Cetirizine finished dose Chlorhexidine finished dose Chlorphenamine finished dose Chlorpheniramine finished dose Chlorpromazine finished dose Chlorthalidone finished dose Chlorzoxazone finished dose Ciclesonide finished dose Ciclopirox finished dose Cilostazol finished dose Cinacalcet finished dose Cisplatin finished dose Citalopram finished dose Clarithromycin finished dose Clindamycin finished dose Clobetasol finished dose Clopidogrel finished dose Clotrimazole finished dose Clozapine finished dose Codeine finished dose Colesevelam finished dose Cyproterone finished dose Dabigatran Etexilate finished dose Dabigatran Etexilate Mesilate finished dose Dapagliflozin finished dose Dapagliflozin Propanediol finished dose Darunavir finished dose Deferasirox API Desloratadine API Desmopressin finished dose Desogestrel finished dose Dextroamphetamine finished dose Dextromethorphan finished dose Diclofenac finished dose Diltiazem finished dose Dimethyl finished dose Dipyridamole finished dose Docetaxel finished dose Donepezil finished dose Dorzolamide finished dose Doxorubicin finished dose Doxycycline finished dose Drospirenone finished dose Dutasteride finished dose Efavirenz finished dose Eltrombopag finished dose Emtricitabine finished dose Enalapril finished dose Enoxaparin finished dose Entecavir finished dose Enzalutamide finished dose Epinephrine finished dose Eribulin finished dose Erlotinib finished dose Escitalopram finished dose Esomeprazole API Estradiol finished dose Ethinylestradiol finished dose Etoposide finished dose Etoricoxib API Exemestane finished dose Ezetimibe API Famotidine finished dose Favipiravir finished dose Fentanyl finished dose Fingolimod finished dose Fluconazole API Fluocinolone Acetonide finished dose Fluphenazine finished dose Fluticasone finished dose Formoterol finished dose Fulvestrant finished dose Gabapentin finished dose Ganciclovir finished dose Gefitinib finished dose Gemcitabine finished dose Gentamicin finished dose Glimepiride API Glycopyrronium finished dose Guaifenesin finished dose Hydralazine finished dose Hydrochlorothiazide finished dose Hydrocortisone finished dose Ibandronate finished dose Ibandronic Acid finished dose Icatibant finished dose Ifosfamide finished dose Imatinib finished dose Imipenem finished dose Imiquimod finished dose Indacaterol finished dose Indapamide finished dose Indomethacin finished dose Ipratropium finished dose Irinotecan finished dose Itraconazole finished dose Ketoconazole finished dose Lacosamide finished dose Lamotrigine finished dose Lansoprazole finished dose Latanoprost finished dose Leflunomide finished dose Lenalidomide finished dose Lercanidipine finished dose Letrozole finished dose Leucovorin finished dose Levocetirizine finished dose Levofloxacin finished dose Levonorgestrel finished dose Levosalbutamol finished dose Levothyroxine finished dose Lidocaine finished dose Linezolid finished dose Loratadine finished dose Lornoxicam API Lovastatin finished dose Lurasidone API Meloxicam finished dose Memantine finished dose Meropenem finished dose Metformin finished dose Micafungin finished dose Miconazole finished dose Minocycline finished dose Minoxidil finished dose Mirabegron finished dose Mometasone finished dose Montelukast finished dose Mupirocin finished dose Naphazoline finished dose Nebivolol finished dose Nefopam finished dose Neomycin finished dose Nicardipine finished dose Nintedanib API Nitrofurantoin finished dose Nizatidine finished dose Norethisterone finished dose Norgestimate finished dose Nortriptyline finished dose Nystatin finished dose Octreotide finished dose Olanzapine finished dose Olmesartan Medoxomil API Olopatadine finished dose Omeprazole finished dose Ondansetron finished dose Orlistat finished dose Oxaliplatin finished dose Oxytocin finished dose Paclitaxel finished dose Pantoprazole finished dose Paracetamol finished dose Paricalcitol finished dose Pazopanib finished dose Pemetrexed finished dose Perindopril API Perindopril Tert-Butylamine finished dose Phenylephrine finished dose Phylloquinone finished dose Pimecrolimus finished dose Pirfenidone finished dose Polymyxin B finished dose Pomalidomide finished dose Posaconazole finished dose Pramipexole finished dose Pregabalin finished dose Prilocaine finished dose Progesterone finished dose Proguanil finished dose Promethazine finished dose Propafenone finished dose Quetiapine finished dose Raloxifene finished dose Ranitidine finished dose Ranolazine finished dose Rasagiline API Repaglinide finished dose Riluzole finished dose Risperidone finished dose Rivaroxaban finished dose Rizatriptan finished dose Ropinirole finished dose Rosuvastatin API Rufinamide finished dose Salbutamol finished dose Salmeterol finished dose Saxagliptin finished dose Silver Sulfadiazine finished dose Simvastatin finished dose Sirolimus finished dose Sitagliptin API Solifenacin finished dose Sucralfate finished dose Sugammadex finished dose Sulfamethoxazole finished dose Sunitinib finished dose Tacrolimus finished dose Tamsulosin finished dose Tazarotene API Telmisartan API Temozolomide finished dose Tenofovir Disoproxil finished dose Terbinafine finished dose Teriflunomide finished dose Theophylline finished dose Ticagrelor API Tigecycline finished dose Timolol finished dose Tinidazole finished dose Tiotropium finished dose Tofacitinib API Topiramate finished dose Travoprost finished dose Trazodone finished dose Tretinoin finished dose Trimethoprim finished dose Trospium finished dose Ursodeoxycholic Acid finished dose Valganciclovir finished dose Vancomycin finished dose Varenicline finished dose Vilanterol finished dose Vildagliptin API Vinorelbine finished dose Voriconazole API Zoledronic Acid finished dose Zolmitriptan finished dose Zonisamide finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
MHRA (UK) 457 6
EMA 304 38
US FDA 278 1
ANVISA (Brazil) 229 8
SAHPRA (ZA) 140 None
DAV (Vietnam) 115 None
CDSCO (India) None 13
NAFDAC (NG) None 3
UZPHARM (UZ) None 3
INVIMA (CO) None 2
MFDS (Korea) None 2
FDA (GH) None 1
TMDA (TZ) None 1

Questions about Glenmark Pharmaceuticals s.r.o

Does Glenmark Pharmaceuticals s.r.o hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Glenmark Pharmaceuticals s.r.o. It does have 2,751 filings with 40 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
How did Glenmark Pharmaceuticals s.r.o's last inspection go?
The most recent inspection on record closed on 20 September 2024 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file, of which 3 closed as OAI.
Where does Glenmark Pharmaceuticals s.r.o manufacture?
12 registered sites are on record, in United Arab Emirates, Brazil, Colombia and Czech Republic (Nasik, Tehsil Baddi and Goa among others). Every site is listed on this page with the register it came from.
What does Glenmark Pharmaceuticals s.r.o make?
27 molecules are on record against Glenmark Pharmaceuticals s.r.o, including Lornoxicam, Desloratadine, Adapalene and Apremilast. Each links through to that molecule's full manufacturer list.
Which regulators recognise Glenmark Pharmaceuticals s.r.o's GMP?
Current GMP certificates are on record from EMA, CDSCO (India), ANVISA (Brazil), MHRA (UK), NAFDAC (NG) and 6 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

  • 58 active litigation matters are on record.
  • The most recent inspection outcome was NAI, on 20 September 2024.

Comparable suppliers

Alivus Life Sciences shares 20 molecules Hetero shares 14 molecules Dr Reddy's Laboratories shares 14 molecules Macleods Pharmaceuticals shares 13 molecules Zydus Lifesciences shares 12 molecules

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