Suppliers / Purisys

Purisys

United States 32 employees Updated 9 July 2026

Purisys is an API manufacturer based in United States. It holds 7 active US drug master files across a filed portfolio of 6 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 13 March 2024 as VAI.

7
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 13 March 2024 VAI US FDA
  • 15 June 2017 NAI US FDA

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

Registered plants

Site FDA FEI
Athens, United States 3012286613

What they file, and where

Molecule Regulators Docs
Dronabinol US FDA 2
Cannabidiol US FDA 1
Dexmethylphenidate US FDA 1
Nabilone US FDA 1
Nalmefene US FDA 1
Psilocybin US FDA 1

Also appears on these molecule pages

Cannabidiol API Dexmethylphenidate API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Purisys

Does Purisys hold a US DMF or a CEP?
Purisys holds 7 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 Purisys FDA-registered?
One site operated by Purisys 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 Purisys's last inspection go?
The most recent inspection on record closed on 13 March 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Purisys manufacture?
1 registered site is on record, in United States (Athens). Every site is listed on this page with the register it came from.
What does Purisys make?
6 molecules are on record against Purisys, including Dronabinol, Cannabidiol, Dexmethylphenidate and Nabilone. Each links through to that molecule's full manufacturer list.
Which regulators recognise Purisys'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 13 March 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