Suppliers / Yung Shin Pharmaceutical

Yung Shin Pharmaceutical

Taiwan reconciled across 9 public records · 4 entities Updated 9 July 2026

Yung Shin Pharmaceutical is an API and finished-dose manufacturer based in Taiwan. It holds 12 active US drug master files across a filed portfolio of 12 molecules. Its filings concentrate with NPRA (MY) and US FDA. Its GMP standing is certified by MFDS (Korea) and EMA. Its most recent recorded inspection, by US FDA, closed on 22 October 2019 as VAI.

12
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
21
filings across 2 regulators

Inspection history

  • 22 October 2019 VAI US FDA
  • 27 July 2018 VAI US FDA
  • 8 May 2014 NAI US FDA
  • 16 August 2013 NAI US FDA
  • 30 April 2012 VAI US FDA
  • 5 February 2010 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 3002808536
Tachia, Taiwan Not on file

What they file, and where

Molecule Regulators Docs
Cabazitaxel US FDA 2
Cinacalcet US FDA 2
Docetaxel US FDA 2
Eletriptan US FDA 2
Entecavir US FDA 2
Famotidine US FDA 2
Meclofenamic Acid US FDA 2
Micafungin US FDA 2
Omeprazole US FDA 2
Paclitaxel US FDA 2
Show all 12 molecules on file
Voriconazole US FDA 2
Zoledronic Acid US FDA 2

Also appears on these molecule pages

Cabazitaxel API Cinacalcet API Clavulanic Acid finished dose Docetaxel API Eletriptan API Entecavir API Famotidine API Micafungin API Paclitaxel API Zoledronic Acid API Zolpidem finished dose Omeprazole API
Show 1 more molecule pages
Voriconazole API

Filings and GMP by regulator

Regulator Filings GMP certificates
NPRA (MY) 16 None
US FDA 5 None
MFDS (Korea) None 2
EMA None 1

Questions about Yung Shin Pharmaceutical

Does Yung Shin Pharmaceutical hold a US DMF or a CEP?
Yung Shin Pharmaceutical holds 12 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 Yung Shin Pharmaceutical FDA-registered?
One site operated by Yung Shin Pharmaceutical 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 Yung Shin Pharmaceutical's last inspection go?
The most recent inspection on record closed on 22 October 2019 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Yung Shin Pharmaceutical manufacture?
2 registered sites are on record, in Taiwan (Taiwan and Tachia). Every site is listed on this page with the register it came from.
What does Yung Shin Pharmaceutical make?
12 molecules are on record against Yung Shin Pharmaceutical, including Cabazitaxel, Cinacalcet, Docetaxel and Eletriptan. Each links through to that molecule's full manufacturer list.
Which regulators recognise Yung Shin Pharmaceutical's GMP?
Current GMP certificates are on record from MFDS (Korea) 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 VAI, on 22 October 2019.

Comparable suppliers

Hetero shares 9 molecules Apitoria Pharma shares 5 molecules Dr Reddy's Laboratories shares 5 molecules ScinoPharm Taiwan shares 4 molecules MSN Laboratories shares 3 molecules

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