Is Vericel Corporation FDA approved?

Vericel Corporation holds 2 FDA-registered establishments 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 Vericel Corporation's drugs manufactured?

The FDA register lists Burlington, MA; Cambridge, MA. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

What drugs does Vericel Corporation make?

4 products are listed under Vericel Corporation in the openFDA NDC Directory, most often as kit; implant. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Vericel Corporation

Data as of 28 Sept 2026 · How to read this entry

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Registered sites: 2
Active NDC listings: 4
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing2Active ingredient (API) manufacture2Labelling2Finished drug manufacture2Packaging2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Vericel Corporation	25 Blue Sky Dr, Burlington, Massachusetts (MA) 01803, United States (USA)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3038730492119545111
Vericel Corporation	64 Sidney St, Cambridge, Massachusetts (MA) 02139, United States (USA)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3002836339787406107

Catalogue

Drug listings by form and route

4 active NDC listings: 3 human prescription drug, 1 cellular therapy. By marketing category: BLA 4.

Dosage form	NDCs
kit	3
implant	1

Route	NDCs
topical	3
intra-articular	1

Labeller name on the listing	NDCs
vericel corporation	4

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
MACI	autologous cultured chondrocytes	implant, intra-articular	69866-1030BLA
NEXOBRID	ANACAULASE-BCDB	kit, topical	69866-2002BLA
NEXOBRID	ANACAULASE-BCDB	kit, topical	69866-2005BLA
NEXOBRID	ANACAULASE-BCDB	kit, topical	69866-2015BLA

Neighbours

Registered in the same town

Shire Human Genetic Therapies, Inc.Cambridge, MA
Alnylam Pharmaceuticals, Inc.Cambridge, MA
SQ Innovation, IncBurlington, MA

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Enquiry

Common questions

Is Vericel Corporation FDA approved?: Vericel Corporation holds 2 FDA-registered establishments 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 Vericel Corporation's drugs manufactured?: The FDA register lists Burlington, MA; Cambridge, MA. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
What drugs does Vericel Corporation make?: 4 products are listed under Vericel Corporation in the openFDA NDC Directory, most often as kit; implant. 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.