Is Spark Therapeutics, Inc. FDA approved?

Spark Therapeutics, 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 Spark Therapeutics, Inc.'s drugs manufactured?

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

What drugs does Spark Therapeutics, Inc. make?

1 product is listed under Spark Therapeutics, 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.

Spark Therapeutics, 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
Spark Therapeutics, Inc.	3737 Market Street, Suite 1300, Philadelphia, Pennsylvania (PA) 19104, United States (USA)	Analytical testing, Active ingredient (API) manufacture	3011194531079498241

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
LUXTURNA	voretigene neparvovec-rzyl	kit	71394-415BLA

Neighbours

Registered in the same town

Catalent Pharma Solutions Inc.Philadelphia, PA
AstraZeneca PLCPhiladelphia, PA
Frontida BioPharm, LLCPhiladelphia, PA
Iovance Biotherapeutics, Inc.Philadelphia, PA
Medical Products Laboratories, Inc.Philadelphia, PA
Premier Dental Products CompanyPhiladelphia, PA
Trustees of the University of PennsylvaniaPhiladelphia, PA
USWM CT, LLCPhiladelphia, PA

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Common questions

Is Spark Therapeutics, Inc. FDA approved?: Spark Therapeutics, 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 Spark Therapeutics, Inc.'s drugs manufactured?: The FDA register lists Philadelphia, PA. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does Spark Therapeutics, Inc. make?: 1 product is listed under Spark Therapeutics, 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.