Suppliers / Htl

Htl

France Updated 9 July 2026

Htl is an API manufacturer based in France. It holds 2 active US drug master files. Its GMP standing is certified by ANSM (FR). Its most recent recorded inspection, by US FDA, closed on 15 June 2018 as NAI.

2
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 15 June 2018 NAI US FDA
  • 7 March 2013 NAI US FDA
  • 19 June 2009 NAI US FDA

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

Registered plants

Site FDA FEI
JAVENE, France Not on file
France, France 3006408331

What they file, and where

Molecule Regulators Docs
Hyaluronic Acid US FDA 2

Also appears on these molecule pages

Hyaluronic Acid API

Filings and GMP by regulator

Regulator Filings GMP certificates
ANSM (FR) None 12

Questions about Htl

Does Htl hold a US DMF or a CEP?
Htl holds 2 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Htl FDA-registered?
One site operated by Htl 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 Htl's last inspection go?
The most recent inspection on record closed on 15 June 2018 as NAI (No Action Indicated: nothing objectionable was found). 3 inspections are on file.
Where does Htl manufacture?
2 registered sites are on record, in France (Javene and France). Every site is listed on this page with the register it came from.
What does Htl make?
1 molecule is on record against Htl, including Hyaluronic Acid. Each links through to that molecule's full manufacturer list.
Which regulators recognise Htl's GMP?
Current GMP certificates are on record from ANSM (FR). 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 15 June 2018.

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates