Suppliers / Théa PHARMA

Théa PHARMA

France 3 duplicate records merged Updated 9 July 2026

Théa PHARMA is a finished-dose manufacturer based in France. It appears in 50 regulatory filings across 4 regulators, without an active US DMF or CEP on file. Its filings concentrate with SWISSMEDIC (CH), US FDA and TITCK (TR). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 18 October 2024 as NAI.

0
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
50
filings across 4 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 18 October 2024 NAI US FDA
  • 6 June 2024 NAI US FDA

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

Registered plants

Site FDA FEI
Schaffhausen, Switzerland Not on file
Waltham, United States 3022351866

Filings and GMP by regulator

Regulator Filings GMP certificates
SWISSMEDIC (CH) 36 None
US FDA 7 1
TITCK (TR) 5 None
ISP (CL) 2 None

Questions about Théa PHARMA

Does Théa PHARMA hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Théa PHARMA. It does have 50 filings with 4 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Théa PHARMA FDA-registered?
One site operated by Théa PHARMA carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Théa PHARMA's last inspection go?
The most recent inspection on record closed on 18 October 2024 as NAI (No Action Indicated: nothing objectionable was found). 2 inspections are on file.
Where does Théa PHARMA manufacture?
2 registered sites are on record, in Switzerland and United States (Schaffhausen and Waltham). Every site is listed on this page with the register it came from.
Which regulators recognise Théa PHARMA's GMP?
Current GMP certificates are on record from US FDA. 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 NAI, on 18 October 2024.

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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