Suppliers / HAS Healthcare Advanced Synthesis

HAS Healthcare Advanced Synthesis

Switzerland 105 employees Updated 9 July 2026

HAS Healthcare Advanced Synthesis is an API manufacturer based in Switzerland. It holds 16 active US drug master files across a filed portfolio of 8 molecules. Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 20 February 2025 as NAI.

16
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
4 of 4 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 20 February 2025 NAI US FDA
  • 4 May 2018 NAI US FDA
  • 11 April 2014 NAI US FDA
  • 4 April 2012 NAI US FDA

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

Registered plants

Site FDA FEI
Biasca, Switzerland Not on file
Switzerland, Switzerland 3002807151

What they file, and where

Molecule Regulators Docs
Adapalene US FDA 2
Dantrolene US FDA 2
Fosnetupitant US FDA 2
Isotretinoin US FDA 2
Mechlorethamine US FDA 2
Netupitant US FDA 2
Palonosetron US FDA 2
Trifarotene US FDA 2

Also appears on these molecule pages

Adapalene API Dantrolene API Isotretinoin API Palonosetron API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1
EMA None 1

Questions about HAS Healthcare Advanced Synthesis

Does HAS Healthcare Advanced Synthesis hold a US DMF or a CEP?
HAS Healthcare Advanced Synthesis holds 16 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 HAS Healthcare Advanced Synthesis FDA-registered?
One site operated by HAS Healthcare Advanced Synthesis 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 HAS Healthcare Advanced Synthesis's last inspection go?
The most recent inspection on record closed on 20 February 2025 as NAI (No Action Indicated: nothing objectionable was found). 4 inspections are on file.
Where does HAS Healthcare Advanced Synthesis manufacture?
2 registered sites are on record, in Switzerland (Biasca and Switzerland). Every site is listed on this page with the register it came from.
What does HAS Healthcare Advanced Synthesis make?
8 molecules are on record against HAS Healthcare Advanced Synthesis, including Adapalene, Dantrolene, Fosnetupitant and Isotretinoin. Each links through to that molecule's full manufacturer list.
Which regulators recognise HAS Healthcare Advanced Synthesis's GMP?
Current GMP certificates are on record from US FDA and EMA. 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 20 February 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