Suppliers / Syn-Tech Chem. & Pharm

Syn-Tech Chem. & Pharm

Taiwan 1777.TWO Updated 9 July 2026

Syn-Tech Chem. & Pharm is an API manufacturer based in Taiwan. It holds 20 active US drug master files across a filed portfolio of 17 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 19 September 2025 as VAI.

20
active US DMFs
0
valid CEPs
1
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
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 19 September 2025 VAI US FDA
  • 15 March 2019 NAI US FDA
  • 29 January 2015 NAI US FDA
  • 12 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
Taiwan, Taiwan 3002808302

What they file, and where

Molecule Regulators Docs
Diclofenac US FDA 3
Granisetron US FDA 2
Timolol US FDA 2
Tolperisone SFDA (Saudi Arabia), US FDA 2
Chlorzoxazone US FDA 1
Crotamiton US FDA 1
Epinephrine SFDA (Saudi Arabia) 1
Lamotrigine US FDA 1
Metaxalone US FDA 1
Mirtazapine US FDA 1
Show all 17 molecules on file
Naftopidil US FDA 1
Phenylephrine US FDA 1
Pramocaine US FDA 1
Rabeprazole US FDA 1
Riluzole US FDA 1
Rizatriptan US FDA 1
Zolmitriptan US FDA 1

Also appears on these molecule pages

Show 3 more molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Syn-Tech Chem. & Pharm

Does Syn-Tech Chem. & Pharm hold a US DMF or a CEP?
Syn-Tech Chem. & Pharm holds 20 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 Syn-Tech Chem. & Pharm FDA-registered?
One site operated by Syn-Tech Chem. & Pharm 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 Syn-Tech Chem. & Pharm's last inspection go?
The most recent inspection on record closed on 19 September 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Syn-Tech Chem. & Pharm manufacture?
1 registered site is on record, in Taiwan (Taiwan). Every site is listed on this page with the register it came from.
What does Syn-Tech Chem. & Pharm make?
17 molecules are on record against Syn-Tech Chem. & Pharm, including Diclofenac, Granisetron, Timolol and Tolperisone. Each links through to that molecule's full manufacturer list.
Which regulators recognise Syn-Tech Chem. & Pharm'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 VAI, on 19 September 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