Is Aurinia Pharma U.S., Inc. FDA approved?

Aurinia Pharma U.S., 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 Aurinia Pharma U.S., Inc.'s drugs manufactured?

The FDA register lists Rockville, MD. Registered operations: finished drug manufacture.

What drugs does Aurinia Pharma U.S., Inc. make?

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

Aurinia Pharma U.S., 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: 3
Countries: 1
Base: United States

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Aurinia Pharma U.S., Inc.	77 Upper Rock Circle, Rockville, Maryland (MD) 20850-4021, United States (USA)	Finished drug manufacture	3016702679117485579

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
7332472	LUPKYNISvoclosporin	substance, product	Oct 2027
10286036	LUPKYNISvoclosporin	use	Dec 2037
11622991	LUPKYNISvoclosporin	use	Dec 2037

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
LUPKYNIS	Voclosporin	capsule, oral	75626-001NDA

Neighbours

Registered in the same town

Sigma-Aldrich CorporationRockville, MD
Bora Pharmaceutical Laboratories Inc.Rockville, MD
Samsung Biologics Co., Ltd.Rockville, MD
Supernus Pharmaceuticals IncRockville, MD

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Enquiry

Common questions

Is Aurinia Pharma U.S., Inc. FDA approved?: Aurinia Pharma U.S., 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 Aurinia Pharma U.S., Inc.'s drugs manufactured?: The FDA register lists Rockville, MD. Registered operations: finished drug manufacture.
What drugs does Aurinia Pharma U.S., Inc. make?: 1 product is listed under Aurinia Pharma U.S., Inc. in the openFDA NDC Directory, most often as capsule. 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.