Suppliers / Novartis

Novartis

Switzerland 11 duplicate records merged Updated 9 July 2026

Novartis is an API and finished-dose manufacturer based in Switzerland. It holds 10 active US drug master files and 3 valid CEPs across a filed portfolio of 12 molecules. Its filings concentrate with Health Canada, MHRA (UK) and US FDA. Its GMP standing is certified by ZLG (DE), ANSM (FR) and EMA, among 11 authorities. Its most recent recorded inspection, by US FDA, closed on 27 January 2026 as NAI.

10
active US DMFs
3
valid CEPs
12
registered plants 2 with an FDA FEI number
241
filings across 15 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 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

  • 27 January 2026 NAI US FDA
  • 8 August 2024 VAI US FDA
  • 26 January 2024 VAI US FDA
  • 14 December 2023 VAI US FDA
  • 22 September 2023 VAI US FDA
  • 9 December 2022 VAI US FDA
  • 30 August 2022 VAI US FDA
  • 19 November 2020 VAI US FDA

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

Registered plants

Site FDA FEI
Torre Annunziata (NA), United Arab Emirates Not on file
Torre Annunziata, United Arab Emirates Not on file
STEIN, United Arab Emirates Not on file
North carolina, United Arab Emirates Not on file
Nuremberg, United Arab Emirates Not on file
Langkampfen, United Arab Emirates Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Amlodipine EDQM, US FDA 2
Sirolimus US FDA 2
Valsartan EDQM, US FDA 2
Ferric Carboxymaltose SFDA (Saudi Arabia) 1
Fluvastatin US FDA 1
Indacaterol SFDA (Saudi Arabia) 1
Letrozole EDQM 1
Mycophenolic Acid US FDA 1
Naftifine US FDA 1
Pentetreotide US FDA 1
Show all 12 molecules on file
Terbinafine US FDA 1
Topotecan US FDA 1

Also appears on these molecule pages

Amlodipine API Atorvastatin finished dose Baclofen finished dose Benazepril finished dose Brinzolamide finished dose Carbamazepine finished dose Chlorthalidone finished dose Ciclosporin finished dose Cyclosporine finished dose Deferasirox finished dose Dexmethylphenidate finished dose Diclofenac finished dose
Show 53 more molecule pages
Eltrombopag finished dose Everolimus finished dose Famciclovir finished dose Ferric Carboxymaltose API Fingolimod finished dose Fluorescein finished dose Fluorometholone finished dose Fluvastatin API Formoterol finished dose Heparin finished dose Hydralazine finished dose Hydrochlorothiazide finished dose Hydroxyurea finished dose Imatinib finished dose Indacaterol API Isoniazid finished dose Lapatinib finished dose Letrozole API Methylphenidate finished dose Midostaurin finished dose Moxifloxacin finished dose Mycophenolic Acid API Naftifine API Naphazoline finished dose Nateglinide finished dose Nelarabine finished dose Nepafenac finished dose Nilotinib finished dose Octreotide finished dose Olopatadine finished dose Oxcarbazepine finished dose Oxytetracycline finished dose Oxytocin finished dose Pazopanib finished dose Phentolamine finished dose Pirfenidone finished dose Polymyxin B finished dose Quinapril finished dose Ribociclib finished dose Rivastigmine finished dose Ruxolitinib finished dose Sacubitril finished dose Siponimod finished dose Sirolimus API Tacrolimus finished dose Tamsulosin finished dose Terbinafine API Terbutaline finished dose Tobramycin finished dose Trametinib finished dose Travoprost finished dose Valsartan API Vildagliptin finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
Health Canada 718 None
MHRA (UK) 432 6
US FDA 396 5
SWISSMEDIC (CH) 290 None
AIFA (IT) 286 None
DH (HK) 206 None
ZLG (DE) None 28
ANSM (FR) None 26
EMA None 23
ANVISA (Brazil) None 12
MFDS (Korea) None 10
EAEU_EEC None 7
NAFDAC (NG) None 6
NCELS (KZ) None 2
EDA (EG) None 1

Questions about Novartis

Does Novartis hold a US DMF or a CEP?
Novartis holds 10 active US drug master files and 3 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 Novartis FDA-registered?
2 sites operated by Novartis 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 Novartis's last inspection go?
The most recent inspection on record closed on 27 January 2026 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Novartis manufacture?
12 registered sites are on record, in United Arab Emirates and Austria (Torre Annunziata (na), Torre Annunziata and Stein among others). Every site is listed on this page with the register it came from.
What does Novartis make?
12 molecules are on record against Novartis, including Amlodipine, Sirolimus, Valsartan and Ferric Carboxymaltose. Each links through to that molecule's full manufacturer list.
Which regulators recognise Novartis's GMP?
Current GMP certificates are on record from ZLG (DE), ANSM (FR), EMA, ANVISA (Brazil), MFDS (Korea) 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

  • The most recent inspection outcome was NAI, on 27 January 2026.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates