Suppliers / ScieGen Pharmaceuticals

ScieGen Pharmaceuticals

United States 175 employees Updated 9 July 2026

ScieGen Pharmaceuticals is a finished-dose manufacturer based in United States. It appears in 39 regulatory filings across 3 regulators, without an active US DMF or CEP on file. 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 19 December 2025 as NAI.

0
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
39
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 19 December 2025 NAI US FDA
  • 20 February 2024 NAI US FDA
  • 21 April 2023 OAI US FDA
  • 2 September 2022 VAI US FDA
  • 20 December 2021 VAI US FDA
  • 21 June 2019 VAI US FDA
  • 20 April 2018 NAI US FDA
  • 16 March 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
Hauppauge, United States 3008298016

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 31 1
DMP (NO) 6 None
SFDA (Saudi Arabia) 2 None

Questions about ScieGen Pharmaceuticals

Does ScieGen Pharmaceuticals hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for ScieGen Pharmaceuticals. It does have 39 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is ScieGen Pharmaceuticals FDA-registered?
One site operated by ScieGen Pharmaceuticals 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 ScieGen Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 19 December 2025 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file, of which 1 closed as OAI.
Where does ScieGen Pharmaceuticals manufacture?
1 registered site is on record, in United States (Hauppauge). Every site is listed on this page with the register it came from.
Which regulators recognise ScieGen Pharmaceuticals'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

  • The most recent inspection outcome was NAI, on 19 December 2025.

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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