Suppliers / Benuvia Operations

Benuvia Operations

United States Updated 9 July 2026

Benuvia Operations is an API manufacturer based in United States. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its GMP standing is certified by ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 20 September 2021 as NAI.

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

  • 20 September 2021 NAI US FDA
  • 12 September 2017 VAI US FDA

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

Registered plants

Site FDA FEI
ROUND ROCK, United States Not on file
Round Rock, United States 3011419064

What they file, and where

Molecule Regulators Docs
Cannabidiol US FDA 1
Dronabinol US FDA 1

Also appears on these molecule pages

Cannabidiol API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 1 None
ANVISA (Brazil) None 2

Questions about Benuvia Operations

Does Benuvia Operations hold a US DMF or a CEP?
Benuvia Operations holds 2 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 Benuvia Operations FDA-registered?
One site operated by Benuvia Operations 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 Benuvia Operations's last inspection go?
The most recent inspection on record closed on 20 September 2021 as NAI (No Action Indicated: nothing objectionable was found). 2 inspections are on file.
Where does Benuvia Operations manufacture?
2 registered sites are on record, in United States (Round Rock and Round Rock). Every site is listed on this page with the register it came from.
What does Benuvia Operations make?
2 molecules are on record against Benuvia Operations, including Cannabidiol and Dronabinol. Each links through to that molecule's full manufacturer list.
Which regulators recognise Benuvia Operations's GMP?
Current GMP certificates are on record from ANVISA (Brazil). 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 20 September 2021.

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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