Suppliers / Agno Pharma

Agno Pharma

United States 55 employees reconciled across 4 public records · 2 entities Updated 9 July 2026

Agno Pharma is an API manufacturer based in United States. It holds 12 active US drug master files across a filed portfolio of 8 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 7 June 2024 as VAI.

12
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
0
filings across 0 regulators

Inspection history

  • 7 June 2024 VAI US FDA
  • 7 November 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
China, China 3009530424

What they file, and where

Molecule Regulators Docs
Carmustine SFDA (Saudi Arabia), US FDA 3
Cannabidiol US FDA 2
Indomethacin US FDA 2
Isosulfan Blue US FDA 2
Polidocanol US FDA 2
Sodium Tetradecyl Sulfate US FDA 2
Sulindac US FDA 2
Tetrabenazine US FDA 2

Also appears on these molecule pages

Cannabidiol API Carmustine API Indomethacin API Isosulfan Blue API Sulindac API Tetrabenazine API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Agno Pharma

Does Agno Pharma hold a US DMF or a CEP?
Agno Pharma holds 12 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 Agno Pharma FDA-registered?
One site operated by Agno 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 Agno Pharma's last inspection go?
The most recent inspection on record closed on 7 June 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Agno Pharma manufacture?
1 registered site is on record, in China (China). Every site is listed on this page with the register it came from.
What does Agno Pharma make?
8 molecules are on record against Agno Pharma, including Carmustine, Cannabidiol, Indomethacin and Isosulfan Blue. Each links through to that molecule's full manufacturer list.
Which regulators recognise Agno 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

  • The most recent inspection outcome was VAI, on 7 June 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