Suppliers / Shire Human Genetic Therapies

Shire Human Genetic Therapies

United States Updated 9 July 2026

Shire Human Genetic Therapies is a finished-dose manufacturer based in United States. It appears in 23 regulatory filings across 6 regulators, without an active US DMF or CEP on file. Its filings concentrate with Health Canada, ANMAT (AR) and ANPP (DZ). Its GMP standing is certified by US FDA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 18 December 2025 as VAI. Customs aggregates show $3.2M of exports covering 1 molecule to 1 destination in 2024.

0
active US DMFs
0
valid CEPs
5
registered plants 4 with an FDA FEI number
23
filings across 6 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
4 of 4 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 18 December 2025 VAI US FDA
  • 12 September 2025 VAI US FDA
  • 22 April 2022 VAI US FDA
  • 15 January 2020 NAI US FDA
  • 25 July 2018 VAI US FDA
  • 1 February 2018 VAI US FDA
  • 20 January 2017 VAI US FDA
  • 5 January 2017 NAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
LEXINGTON, United States Not on file
Cambridge, United States 3005955297
Belmont, United States 3016455338
North Reading, United States 3008424653
Lexington, United States 3009340644

Filings and GMP by regulator

Regulator Filings GMP certificates
Health Canada 13 None
ANMAT (AR) 3 None
ANPP (DZ) 3 None
EMA 2 None
AEMPS (ES) 1 None
INVIMA (CO) 1 None
US FDA None 2
ANVISA (Brazil) None 1

Scale

Year Revenue Exports Destinations
2024 Not reported $3.2M 1

Export figures are customs aggregates. We do not publish the identity of any buyer.

Questions about Shire Human Genetic Therapies

Does Shire Human Genetic Therapies hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Shire Human Genetic Therapies. It does have 23 filings with 6 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Shire Human Genetic Therapies FDA-registered?
4 sites operated by Shire Human Genetic Therapies carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Shire Human Genetic Therapies's last inspection go?
The most recent inspection on record closed on 18 December 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Shire Human Genetic Therapies manufacture?
5 registered sites are on record, in United States (Lexington, Cambridge and Belmont among others). Every site is listed on this page with the register it came from.
Which regulators recognise Shire Human Genetic Therapies's GMP?
Current GMP certificates are on record from US FDA and ANVISA (Brazil). GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was VAI, on 18 December 2025.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates
Customs aggregates
Export values, molecule and destination counts