Is Orca Biosystems Inc. FDA approved?

Orca Biosystems Inc. 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 Orca Biosystems Inc.'s drugs manufactured?

The FDA register lists Sacramento, CA. Registered operations: analytical testing, finished drug manufacture.

What drugs does Orca Biosystems Inc. make?

1 product is listed under Orca Biosystems Inc. in the openFDA NDC Directory, most often as kit. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Orca Biosystems Inc.

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

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

Authorisation

Registered operations

Analytical testing1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Orca Biosystems Inc.	7910 Metro Air Parkway, Sacramento, California (CA) 95837, United States (USA)	Analytical testing, Finished drug manufacture	3035546696119463419

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
TREGZI	allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq	kit	85866-223BLA

Neighbours

Registered in the same town

PETNET Solutions, Inc.SACRAMENTO, CA
Cardinal Health 418, Inc.Sacramento, CA
Analgesic Services IncSacramento, CA
Nivagen Pharmaceuticals LLCSacramento, CA

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Enquiry

Common questions

Is Orca Biosystems Inc. FDA approved?: Orca Biosystems Inc. 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 Orca Biosystems Inc.'s drugs manufactured?: The FDA register lists Sacramento, CA. Registered operations: analytical testing, finished drug manufacture.
What drugs does Orca Biosystems Inc. make?: 1 product is listed under Orca Biosystems Inc. in the openFDA NDC Directory, most often as kit. 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.