Suppliers / Gilead Sciences

Gilead Sciences

United States GILD 7 duplicate records merged Updated 9 July 2026

Gilead Sciences is an API and finished-dose manufacturer based in United States. It holds 3 active US drug master files across a filed portfolio of 3 molecules. Its filings concentrate with AEMPS (ES), URPL (PL) and Health Canada. Its GMP standing is certified by EMA, ZLG (DE) and COFEPRIS (MX), among 13 authorities. Its most recent recorded inspection, by US FDA, closed on 18 February 2026 as VAI.

3
active US DMFs
0
valid CEPs
12
registered plants
3,411
filings across 47 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

  • 18 February 2026 VAI US FDA
  • 16 January 2026 NAI US FDA
  • 30 July 2025 NAI US FDA
  • 27 February 2025 OAI US FDA
  • 29 January 2025 NAI US FDA
  • 22 August 2024 NAI US FDA
  • 22 January 2024 VAI US FDA
  • 25 August 2023 NAI US FDA

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

Registered plants

Site FDA FEI
CAIRO, United Arab Emirates Not on file
Tampa, United Arab Emirates Not on file
Clearwater, United Arab Emirates Not on file
Rochester, United Arab Emirates Not on file
Waterford, United Arab Emirates Not on file
Monza Brianza, United Arab Emirates Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Cobicistat US FDA 1
Elvitegravir US FDA 1
Penicillamine US FDA 1

Also appears on these molecule pages

Acetaminophen finished dose Acyclovir finished dose Ambrisentan finished dose Atazanavir finished dose Atropine finished dose Aztreonam finished dose Benzoyl Peroxide finished dose Bexarotene finished dose Bictegravir finished dose Bimatoprost finished dose Bisacodyl finished dose Brimonidine finished dose
Show 81 more molecule pages
Brinzolamide finished dose Budesonide finished dose Bupropion finished dose Carbidopa finished dose Cefadroxil finished dose Cefuroxime finished dose Chlordiazepoxide finished dose Clindamycin finished dose Clobazam finished dose Clonazepam finished dose Clozapine finished dose Cobicistat API Cromoglicic Acid finished dose Desloratadine finished dose Dexamethasone finished dose Diazepam finished dose Diltiazem finished dose Efavirenz finished dose Elvitegravir API Emtricitabine finished dose Entecavir finished dose Erythromycin finished dose Fexofenadine finished dose Fluocinolone Acetonide finished dose Fluorescein finished dose Fluorometholone finished dose Fluorouracil finished dose Fluvoxamine finished dose Ganciclovir finished dose Halobetasol finished dose Haloperidol finished dose Hydrochlorothiazide finished dose Hydrocortisone finished dose Imiquimod finished dose Indomethacin finished dose Ipratropium finished dose Latanoprost finished dose Latanoprostene Bunod finished dose Lenacapavir finished dose Lifitegrast finished dose Loteprednol Etabonate finished dose Mesalamine finished dose Mesalazine finished dose Metformin finished dose Metronidazole finished dose Milrinone finished dose Minocycline finished dose Mirtazapine finished dose Naphazoline finished dose Neomycin finished dose Ofloxacin finished dose Olopatadine finished dose Paracetamol finished dose Penicillamine API Pentoxifylline finished dose Phenylephrine finished dose Polymyxin B finished dose Povidone-Iodine finished dose Pramocaine finished dose Prednisolone finished dose Primidone finished dose Pyridostigmine finished dose Ribavirin finished dose Rilpivirine finished dose Rivastigmine finished dose Selegiline finished dose Sodium Cromoglicate finished dose Sofosbuvir finished dose Spironolactone finished dose Tazarotene finished dose Tenofovir Alafenamide finished dose Tenofovir Disoproxil finished dose Testosterone finished dose Tetracaine finished dose Timolol finished dose Tobramycin finished dose Travoprost finished dose Tretinoin finished dose Trimethoprim finished dose Zidovudine finished dose Zopiclone finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
AEMPS (ES) 476 None
URPL (PL) 432 None
Health Canada 384 None
EDA (EG) 319 1
EMA 270 12
US FDA 205 5
ZLG (DE) None 10
COFEPRIS (MX) None 8
ANVISA (Brazil) None 5
HSA (SG) None 4
MHRA (UK) None 4
ANSM (FR) None 3
INVIMA (CO) None 2
MFDS (Korea) None 2
UZPHARM (UZ) None 1
NAFDAC (NG) None 1

Scale

Year Revenue Exports Destinations
2020 $7.4B Not reported Not reported
2019 $5.9B Not reported Not reported
2018 $5.8B Not reported Not reported

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

Questions about Gilead Sciences

Does Gilead Sciences hold a US DMF or a CEP?
Gilead Sciences holds 3 active US drug master files. 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.
How did Gilead Sciences's last inspection go?
The most recent inspection on record closed on 18 February 2026 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file, of which 1 closed as OAI.
Where does Gilead Sciences manufacture?
12 registered sites are on record, in United Arab Emirates and Switzerland (Cairo, Tampa and Clearwater among others). Every site is listed on this page with the register it came from.
What does Gilead Sciences make?
3 molecules are on record against Gilead Sciences, including Cobicistat, Elvitegravir and Penicillamine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Gilead Sciences's GMP?
Current GMP certificates are on record from EMA, ZLG (DE), COFEPRIS (MX), US FDA, ANVISA (Brazil) and 8 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

  • 86 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 18 February 2026.

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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
Company filings
Revenue as reported