Suppliers / Genus Lifesciences

Genus Lifesciences

United States 67 employees Updated 9 July 2026

Genus Lifesciences is a finished-dose manufacturer based in United States. It appears in 38 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 31 July 2024 as NAI.

0
active US DMFs
0
valid CEPs
2
registered plants 2 with an FDA FEI number
38
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 31 July 2024 NAI US FDA
  • 23 July 2021 NAI US FDA
  • 20 September 2019 VAI US FDA
  • 28 November 2018 NAI US FDA
  • 20 July 2018 VAI US FDA
  • 29 September 2017 VAI US FDA
  • 11 August 2016 NAI US FDA
  • 17 October 2014 VAI US FDA

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

Registered plants

Site FDA FEI
Allentown, United States 3014677161
Allentown, United States 3003851100

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 38 1

Questions about Genus Lifesciences

Does Genus Lifesciences hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Genus Lifesciences. It does have 38 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Genus Lifesciences FDA-registered?
2 sites operated by Genus Lifesciences 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 Genus Lifesciences's last inspection go?
The most recent inspection on record closed on 31 July 2024 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Genus Lifesciences manufacture?
2 registered sites are on record, in United States (Allentown among others). Every site is listed on this page with the register it came from.
Which regulators recognise Genus Lifesciences'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

  • 37 active litigation matters are on record.
  • The most recent inspection outcome was NAI, on 31 July 2024.

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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