Is Precigen, Inc FDA approved?

Precigen, 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 Precigen, Inc's drugs manufactured?

The FDA register lists Germantown, MD. Registered operations: analytical testing, active ingredient (API) manufacture.

What drugs does Precigen, Inc make?

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

Precigen, 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 testing1Active ingredient (API) manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Precigen, Inc.Registrant: Precigen, Inc	20358 Seneca Meadows Pkwy, Germantown, Maryland (MD) 20876, United States (USA)	Analytical testing, Active ingredient (API) manufacture	3014429654054652865

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
PAPZIMEOS	zopapogene imadenovec	injection, suspension, subcutaneous	84768-511BLA

Neighbours

Registered in the same town

Novavax, Inc.Germantown, MD

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Enquiry

Common questions

Is Precigen, Inc FDA approved?: Precigen, 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 Precigen, Inc's drugs manufactured?: The FDA register lists Germantown, MD. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does Precigen, Inc make?: 1 product is listed under Precigen, Inc in the openFDA NDC Directory, most often as injection, suspension. 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.