Suppliers / Novitium Pharma

Novitium Pharma

United States 114 employees Updated 9 July 2026

Novitium Pharma is an API and finished-dose manufacturer based in United States. It holds 24 active US drug master files across a filed portfolio of 12 molecules. Its filings concentrate with US FDA, DMP (NO) and SFDA (Saudi Arabia). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 16 February 2024 as NAI.

24
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
76
filings across 4 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 16 February 2024 NAI US FDA
  • 31 March 2023 NAI US FDA
  • 8 July 2021 NAI US FDA
  • 4 February 2019 VAI US FDA
  • 9 May 2018 NAI US FDA

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

Registered plants

Site FDA FEI
New Jersey, United Arab Emirates Not on file
East Windsor, United States 3012541241

What they file, and where

Molecule Regulators Docs
Betaine US FDA 2
Carglumic Acid US FDA 2
Dapsone US FDA 2
Diazoxide US FDA 2
Diclofenamide US FDA 2
Fludrocortisone US FDA 2
Levorphanol US FDA 2
Methyltestosterone US FDA 2
Nitisinone US FDA 2
Oxandrolone US FDA 2
Show all 12 molecules on file
Prazosin US FDA 2
Thiothixene US FDA 2

Also appears on these molecule pages

Carglumic Acid API Chlorzoxazone finished dose Cimetidine finished dose Clobazam finished dose Clotrimazole finished dose Dapsone API Diazoxide API Felbamate finished dose Glipizide finished dose Mirtazapine finished dose Naltrexone finished dose Oxandrolone API
Show 6 more molecule pages
Prazosin API Pyridostigmine finished dose Selegiline finished dose Sotalol finished dose Tapentadol finished dose Tetracycline finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 70 1
DMP (NO) 4 None
SFDA (Saudi Arabia) 1 None
EDE (AE) 1 None

Questions about Novitium Pharma

Does Novitium Pharma hold a US DMF or a CEP?
Novitium Pharma holds 24 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.
Is Novitium Pharma FDA-registered?
One site operated by Novitium Pharma 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 Novitium Pharma's last inspection go?
The most recent inspection on record closed on 16 February 2024 as NAI (No Action Indicated: nothing objectionable was found). 5 inspections are on file.
Where does Novitium Pharma manufacture?
2 registered sites are on record, in United Arab Emirates and United States (New Jersey and East Windsor). Every site is listed on this page with the register it came from.
What does Novitium Pharma make?
12 molecules are on record against Novitium Pharma, including Betaine, Carglumic Acid, Dapsone and Diazoxide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Novitium Pharma's GMP?
Current GMP certificates are on record from US FDA. 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

  • 20 active litigation matters are on record.
  • The most recent inspection outcome was NAI, on 16 February 2024.

Comparable suppliers

Nuray Chemicals shares 2 molecules Lundbeck Pharmaceuticals Italy shares 2 molecules MSN Laboratories shares 1 molecule Macleods Pharmaceuticals shares 1 molecule Biophore India Pharmaceuticals shares 1 molecule

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