Is Benuvia Operations, LLC FDA approved?

Benuvia Operations, LLC holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Benuvia Operations, LLC's drugs manufactured?

The FDA register lists Round Rock, TX. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, repackaging.

What drugs does Benuvia Operations, LLC make?

1 product is listed under Benuvia Operations, LLC in the openFDA NDC Directory, most often as solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Benuvia Operations, LLC

Data as of 24 Sept 2026 · How to read this entry

Request a quote Claim this profile

Registered sites: 1
Active NDC listings: 1
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Labelling1Finished drug manufacture1Packaging1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Benuvia Operations, LLC	3950 N Mays St, Round Rock, Texas (TX) 78665, United States (USA)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, Repackaging	3011419064118793457

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
SYNDROS	Dronabinol	solution, oral	78613-201NDA

Neighbours

Registered in the same town

Microchem LaboratoryRound Rock, TX
FluoroMed Products, L.P.Round Rock, TX

Compare

Comparable companies in United States

Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals1 site · 4,853 NDC
NuCare Pharmaceuticals,Inc.1 site · 1,393 NDC
Greer Laboratories, Inc.1 site · 1,328 NDC
ASCLEMED USA INC. DBA ENOVACHEM1 site · 789 NDC
Golden State Medical Supply Inc.1 site · 670 NDC
Rising Pharma Holdings, Inc.1 site · 532 NDC
HF Acquisition Co LLC1 site · 363 NDC
ANI Pharmaceuticals, Inc.1 site · 299 NDC
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 site · 273 NDC
Newton Laboratories, Inc.1 site · 271 NDC

Enquiry

Common questions

Is Benuvia Operations, LLC FDA approved?: Benuvia Operations, LLC holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Benuvia Operations, LLC's drugs manufactured?: The FDA register lists Round Rock, TX. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, repackaging.
What drugs does Benuvia Operations, LLC make?: 1 product is listed under Benuvia Operations, LLC in the openFDA NDC Directory, most often as solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.