Suppliers / Hikma

Hikma

Italy reconciled across 162 public records · 40 entities Updated 9 July 2026

Hikma is an API and finished-dose manufacturer based in Italy. It holds 20 active US drug master files and one valid CEP across a filed portfolio of 22 molecules. Its filings concentrate with US FDA, EDA (EG) and EMA. Its GMP standing is certified by EMA, ZLG (DE) and EDA (EG), among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 17 January 2025 as NAI.

20
active US DMFs
1
valid CEPs
20
registered plants 4 with an FDA FEI number
3,264
filings across 17 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 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

  • 17 January 2025 NAI US FDA
  • 12 June 2024 VAI US FDA
  • 3 November 2023 VAI US FDA
  • 15 September 2022 NAI US FDA
  • 7 July 2022 NAI US FDA
  • 22 November 2019 NAI US FDA
  • 10 September 2019 VAI US FDA
  • 5 September 2019 VAI US FDA
  • 16 April 2019 NAI US FDA
  • 14 September 2018 NAI US FDA
  • 18 April 2018 VAI US FDA
  • 19 September 2017 NAI US FDA

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

Registered plants

Site FDA FEI
Amman, United Arab Emirates Not on file
Terrugem, United Arab Emirates Not on file
Pavia, United Arab Emirates Not on file
Amman, United Arab Emirates Not on file
Amman, United Arab Emirates Not on file
Amman, United Arab Emirates Not on file

14 further sites are on record.

What they file, and where

Molecule Regulators Docs
Zoledronic Acid EDQM, SFDA (Saudi Arabia) 4
Dasatinib SFDA (Saudi Arabia), US FDA 3
Erlotinib SFDA (Saudi Arabia), US FDA 3
Glycopyrronium SFDA (Saudi Arabia), US FDA 3
Gilteritinib SFDA (Saudi Arabia) 2
Ibrutinib SFDA (Saudi Arabia) 2
Neratinib SFDA (Saudi Arabia) 2
Ruxolitinib SFDA (Saudi Arabia) 2
Sunitinib L-Malate SFDA (Saudi Arabia) 2
Betamethasone US FDA 1
Show all 22 molecules on file
Enalaprilat US FDA 1
Granisetron US FDA 1
Hydrocortisone US FDA 1
Methylprednisolone US FDA 1
Milrinone US FDA 1
Nicardipine US FDA 1
Nilotinib US FDA 1
Ondansetron US FDA 1
Oxandrolone US FDA 1
Prednisone US FDA 1
Sunitinib US FDA 1
Umeclidinium Bromide US FDA 1

Also appears on these molecule pages

Acarbose finished dose Acetaminophen finished dose Acetazolamide finished dose Acetylcysteine finished dose Acetylsalicylic Acid finished dose Acyclovir finished dose Adenosine finished dose Albuterol finished dose Alendronic Acid finished dose Allopurinol finished dose Alprazolam finished dose Alprostadil finished dose
Show 253 more molecule pages
Amikacin finished dose Aminocaproic Acid finished dose Amoxicillin finished dose Ampicillin finished dose Anastrozole finished dose Atracurium finished dose Atropine finished dose Azacitidine finished dose Azathioprine finished dose Azelastine finished dose Azithromycin finished dose Aztreonam finished dose Benzatropine finished dose Betamethasone API Bexarotene finished dose Bimatoprost finished dose Bortezomib finished dose Bosentan finished dose Bupivacaine finished dose Buprenorphine finished dose Caffeine finished dose Calcipotriol finished dose Calcitriol finished dose Capecitabine finished dose Carboplatin finished dose Carboprost finished dose Carisoprodol finished dose Carvedilol finished dose Cefaclor finished dose Cefazolin finished dose Cefepime finished dose Cefotaxime finished dose Cefoxitin finished dose Ceftriaxone finished dose Cefuroxime finished dose Cephalexin finished dose Chlorothiazide finished dose Chlorpromazine finished dose Ciclopirox finished dose Ciclosporin finished dose Cilostazol finished dose Cimetidine finished dose Cisatracurium finished dose Cisplatin finished dose Citalopram finished dose Cladribine finished dose Clarithromycin finished dose Clavulanic Acid finished dose Clindamycin finished dose Clobazam finished dose Clobetasol finished dose Clotrimazole finished dose Codeine finished dose Cromoglicic Acid finished dose Cyclophosphamide finished dose Cyclosporine finished dose Cytarabine finished dose Dacarbazine finished dose Dalfampridine finished dose Dantrolene finished dose Daptomycin finished dose Dasatinib API Daunorubicin finished dose Decitabine finished dose Deferiprone finished dose Desvenlafaxine finished dose Dexamethasone finished dose Dexmedetomidine finished dose Dexrazoxane finished dose Dextromethorphan finished dose Diazepam finished dose Diclofenac finished dose Diltiazem finished dose Diphenhydramine finished dose Dobutamine finished dose Docetaxel finished dose Donepezil finished dose Dorzolamide finished dose Doxercalciferol finished dose Doxorubicin finished dose Droxidopa finished dose Dutasteride finished dose Edaravone finished dose Ephedrine finished dose Epirubicin finished dose Eribulin finished dose Erlotinib API Ertapenem finished dose Ertugliflozin finished dose Escitalopram finished dose Esmolol finished dose Estradiol finished dose Eszopiclone finished dose Etomidate finished dose Etoposide finished dose Everolimus finished dose Exemestane finished dose Famciclovir finished dose Famotidine finished dose Flecainide finished dose Fluconazole finished dose Flucytosine finished dose Flumazenil finished dose Fluphenazine finished dose Fluticasone finished dose Foscarnet finished dose Fulvestrant finished dose Furosemide finished dose Gabapentin finished dose Galantamine finished dose Ganciclovir finished dose Gatifloxacin finished dose Gemcitabine finished dose Gentamicin finished dose Glibenclamide finished dose Glimepiride finished dose Glyburide finished dose Glycopyrronium API Granisetron API Haloperidol finished dose Heparin finished dose Hydralazine finished dose Hydrocortisone API Hydromorphone finished dose Hydroxychloroquine finished dose Hydroxyzine finished dose Icatibant finished dose Ifosfamide finished dose Imatinib finished dose Indomethacin finished dose Irbesartan finished dose Irinotecan finished dose Isoniazid finished dose Isoprenaline finished dose Ketorolac Tromethamine finished dose Labetalol finished dose Lacosamide finished dose Lactulose finished dose Lamotrigine finished dose Letrozole finished dose Leucovorin finished dose Levetiracetam finished dose Levocarnitine finished dose Levofloxacin finished dose Levomilnacipran finished dose Levosalbutamol finished dose Levothyroxine finished dose Linezolid finished dose Liraglutide finished dose Lisinopril finished dose Lithium Carbonate finished dose Lorazepam finished dose Losartan finished dose Loteprednol Etabonate finished dose Medroxyprogesterone finished dose Megestrol finished dose Melphalan finished dose Memantine finished dose Meropenem finished dose Mesna finished dose Methadone finished dose Methocarbamol finished dose Methotrexate finished dose Methylene Blue finished dose Methylprednisolone API Metoclopramide finished dose Metoprolol finished dose Micafungin finished dose Midazolam finished dose Milrinone API Minoxidil finished dose Modafinil finished dose Montelukast finished dose Morphine finished dose Mycophenolate Mofetil finished dose Naloxone finished dose Naproxen finished dose Nicardipine API Nilotinib API Octreotide finished dose Ofloxacin finished dose Olanzapine finished dose Olopatadine finished dose Ondansetron API Oxandrolone API Oxcarbazepine finished dose Oxycodone finished dose Oxytetracycline finished dose Oxytocin finished dose Paclitaxel finished dose Palonosetron finished dose Paracetamol finished dose Phentolamine finished dose Phenylephrine finished dose Phylloquinone finished dose Piroxicam finished dose Polymyxin B finished dose Posaconazole finished dose Prednisolone finished dose Prednisone API Primidone finished dose Progesterone finished dose Promethazine finished dose Propofol finished dose Propranolol finished dose Protamine finished dose Prucalopride finished dose Pyrazinamide finished dose Ranitidine finished dose Regadenoson finished dose Remifentanil finished dose Rifampicin finished dose Rifampin finished dose Risperidone finished dose Ritonavir finished dose Rocuronium finished dose Ropinirole finished dose Ropivacaine finished dose Rufinamide finished dose Salbutamol finished dose Sertraline finished dose Sodium Oxybate finished dose Somatostatin finished dose Succinylcholine finished dose Sucralfate finished dose Sulbactam finished dose Sulfamethoxazole finished dose Sumatriptan finished dose Sunitinib API Tapentadol finished dose Terazosin finished dose Testosterone Cypionate finished dose Tetrabenazine finished dose Tetracycline finished dose Thiotepa finished dose Timolol finished dose Tinidazole finished dose Tobramycin finished dose Tofacitinib finished dose Topiramate finished dose Torasemide finished dose Trifluridine finished dose Trimethoprim finished dose Umeclidinium API Valaciclovir finished dose Valacyclovir finished dose Valproic Acid finished dose Vancomycin finished dose Vigabatrin finished dose Vinorelbine finished dose Zidovudine finished dose Zoledronic Acid finished dose Zolpidem finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 973 2
EDA (EG) 756 4
EMA 589 9
AIFA (IT) 491 None
INFARMED (PT) 285 2
Health Canada 242 None
ZLG (DE) None 4

Questions about Hikma

Does Hikma hold a US DMF or a CEP?
Hikma holds 20 active US drug master files and 1 valid CEP. 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 Hikma FDA-registered?
4 sites operated by Hikma 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 Hikma's last inspection go?
The most recent inspection on record closed on 17 January 2025 as NAI (No Action Indicated: nothing objectionable was found). 24 inspections are on file.
Where does Hikma manufacture?
20 registered sites are on record, in United Arab Emirates, Croatia, Italy and Jordan (Amman, Terrugem and Pavia among others). Every site is listed on this page with the register it came from.
What does Hikma make?
22 molecules are on record against Hikma, including Zoledronic Acid, Dasatinib, Erlotinib and Glycopyrronium. Each links through to that molecule's full manufacturer list.
Which regulators recognise Hikma's GMP?
Current GMP certificates are on record from EMA, ZLG (DE), EDA (EG), US FDA and INFARMED (PT). 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

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was NAI, on 17 January 2025.

Comparable suppliers

Cipla shares 7 molecules MSN Laboratories shares 5 molecules Shilpa Pharma Lifesciences shares 5 molecules Hetero shares 4 molecules Dr Reddy's Laboratories shares 4 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