Is Shire Human Genetic Therapies, Inc. FDA approved?

Shire Human Genetic Therapies, Inc. holds 4 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 Shire Human Genetic Therapies, Inc.'s drugs manufactured?

The FDA register lists Belmont, MA; Cambridge, MA; Lexington, MA; North Reading, MA. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.

Shire Human Genetic Therapies, Inc.

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

Request a quote Claim this profile

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

Authorisation

Registered operations

Analytical testing2Active ingredient (API) manufacture2Finished drug manufacture3

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Shire Human Genetic Therapies, Inc.	33 Brighton Street, Belmont, Massachusetts (MA) 02478, United States (USA)	Finished drug manufacture	3016455338831834655
Shire Human Genetic Therapies, Inc.	205 Alewife Brook Parkway, Cambridge, Massachusetts (MA) 02138, United States (USA)	Active ingredient (API) manufacture	3005955297831750356
Shire Human Genetic Therapies, Inc.	200 Shire Way, Lexington, Massachusetts (MA) 02421, United States (USA)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	3009340644078478354
Shire Human Genetic Therapies, Inc.	200 Riverpark Drive, North Reading, Massachusetts (MA) 01864, United States (USA)	Analytical testing, Finished drug manufacture	3008424653831834762

Neighbours

Registered in the same town

Alnylam Pharmaceuticals, Inc.Cambridge, MA
Vericel CorporationCambridge, MA

Compare

Comparable companies in United States

Hikma Pharmaceuticals USA Inc.4 sites · 763 NDC
Church & Dwight Co., Inc.4 sites · 157 NDC
Sterling Pharmaceutical Services, LLC4 sites · 104 NDC
Bausch & Lomb Ireland Limited4 sites · 92 NDC
Grifols Therapeutics LLC4 sites · 53 NDC
Gilead Sciences, Inc.4 sites · 51 NDC
Nice-Pak Products, LLC4 sites · 48 NDC
HOVIONE FARMACIENCIA, S.A.4 sites · 47 NDC
Pacific Medical Industries Ltd4 sites · 41 NDC
United Therapeutics Corporation4 sites · 40 NDC

Enquiry

Common questions

Is Shire Human Genetic Therapies, Inc. FDA approved?: Shire Human Genetic Therapies, Inc. holds 4 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 Shire Human Genetic Therapies, Inc.'s drugs manufactured?: The FDA register lists Belmont, MA; Cambridge, MA; Lexington, MA; North Reading, MA. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.

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.