Is Mesoblast, Inc. FDA approved?

Mesoblast, 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 Mesoblast, Inc.'s drugs manufactured?

The FDA register lists New York, NY. Registered operations: finished drug manufacture.

What drugs does Mesoblast, Inc. make?

12 products are listed under Mesoblast, 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.

Mesoblast, Inc.

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

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Registered sites: 1
Active NDC listings: 12
Live patents: 0
Countries: 1
Base: United States

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Mesoblast, Inc.	1114 6TH Ave FL 4, New York, New York (NY) 10036, United States (USA)	Finished drug manufacture	3012677947616697426

Catalogue

Drug listings by form and route

12 active NDC listings: 12 human prescription drug. By marketing category: BLA 12.

Dosage form	NDCs
kit	12

Route	NDCs

Labeller name on the listing	NDCs
mesoblast	12

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
RYONCIL	remestemcel-l-rknd	kit	73648-111BLA
RYONCIL	remestemcel-l-rknd	kit	73648-112BLA
RYONCIL	remestemcel-l-rknd	kit	73648-113BLA
RYONCIL	remestemcel-l-rknd	kit	73648-114BLA
RYONCIL	remestemcel-l-rknd	kit	73648-115BLA
RYONCIL	remestemcel-l-rknd	kit	73648-116BLA
RYONCIL	remestemcel-l-rknd	kit	73648-117BLA
RYONCIL	remestemcel-l-rknd	kit	73648-118BLA
RYONCIL	remestemcel-l-rknd	kit	73648-119BLA
RYONCIL	remestemcel-l-rknd	kit	73648-120BLA
RYONCIL	remestemcel-l-rknd	kit	73648-121BLA
RYONCIL	remestemcel-l-rknd	kit	73648-122BLA

Neighbours

Registered in the same town

PETNET Solutions, Inc.New York, NY
Brand Buzz LLCNew York, NY
Kreitchman PET CenterNew York, NY
Valorum Biologics, LLCNew York, NY
Zgtl LLCNew York, NY

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Enquiry

Common questions

Is Mesoblast, Inc. FDA approved?: Mesoblast, 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 Mesoblast, Inc.'s drugs manufactured?: The FDA register lists New York, NY. Registered operations: finished drug manufacture.
What drugs does Mesoblast, Inc. make?: 12 products are listed under Mesoblast, 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.