Suppliers / ISP Chemicals

ISP Chemicals

United States Updated 9 July 2026

ISP Chemicals is an API and finished-dose manufacturer based in United States. It holds one valid CEP. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 17 July 2025 as VAI.

0
active US DMFs
1
valid CEPs
2
registered plants 2 with an FDA FEI number
2
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

  • 17 July 2025 VAI US FDA
  • 29 January 2024 VAI US FDA
  • 10 January 2019 NAI US FDA
  • 20 December 2018 NAI US FDA
  • 13 February 2017 NAI US FDA
  • 28 August 2014 NAI US FDA
  • 19 December 2012 NAI US FDA
  • 29 August 2012 NAI US FDA

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

Registered plants

Site FDA FEI
Columbus, United States 1525964
Calvert City, United States 1022245

What they file, and where

Molecule Regulators Docs
Flunixin Meglumine For Veterinary Use EDQM 1

Also appears on these molecule pages

Flunixin Meglumine For Veterinary Use API Triclosan finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
BOMRA (BW) 2 None
US FDA None 2

Questions about ISP Chemicals

Does ISP Chemicals hold a US DMF or a CEP?
ISP Chemicals holds 1 valid CEP. 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 ISP Chemicals FDA-registered?
2 sites operated by ISP Chemicals 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 ISP Chemicals's last inspection go?
The most recent inspection on record closed on 17 July 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does ISP Chemicals manufacture?
2 registered sites are on record, in United States (Columbus and Calvert City). Every site is listed on this page with the register it came from.
What does ISP Chemicals make?
1 molecule is on record against ISP Chemicals, including Flunixin Meglumine For Veterinary Use. Each links through to that molecule's full manufacturer list.
Which regulators recognise ISP Chemicals'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 VAI, on 17 July 2025.

Comparable suppliers

Alivira Animal Health shares 1 molecule Zhejiang Hisoar Pharmaceutical shares 1 molecule Sequent Scientific shares 1 molecule Norbrook Laboratories shares 1 molecule Ngl Fine-Chem 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