Suppliers / Formosa Laboratories

Formosa Laboratories

Taiwan 4746.TW 199 employees 2 duplicate records merged Updated 9 July 2026

Formosa Laboratories is an API manufacturer based in Taiwan. It holds 51 active US drug master files and 8 valid CEPs. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 25 July 2024 as VAI.

51
active US DMFs
8
valid CEPs
2
registered plants 1 with an FDA FEI number
2
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 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

  • 25 July 2024 VAI US FDA
  • 11 November 2022 NAI US FDA
  • 9 November 2018 VAI US FDA
  • 22 January 2015 NAI US FDA
  • 10 May 2012 NAI US FDA
  • 18 June 2009 VAI US FDA

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

Registered plants

Site FDA FEI
Taoyuan, Taiwan Not on file
Taiwan, Taiwan 3003420376

What they file, and where

Molecule Regulators Docs
Calcipotriol EDQM, SFDA (Saudi Arabia), US FDA 6
Calcitriol EDQM, US FDA 3
Sevelamer US FDA 3
Sevelamer Carbonate SFDA (Saudi Arabia) 3
Temozolomide EDQM, SFDA (Saudi Arabia), US FDA 3
Calcifediol EDQM, US FDA 2
Capsaicin SFDA (Saudi Arabia), US FDA 2
Colesevelam US FDA 2
Leflunomide EDQM, US FDA 2
Linezolid SFDA (Saudi Arabia), US FDA 2
Show all 30 molecules on file
Montelukast EDQM, US FDA 2
Mycophenolic Acid US FDA 2
Nintedanib US FDA 2
Paricalcitol SFDA (Saudi Arabia), US FDA 2
Teriflunomide SFDA (Saudi Arabia), US FDA 2
Abemaciclib US FDA 1
Anastrozole US FDA 1
Apraclonidine US FDA 1
Balsalazide US FDA 1
Benzonatate US FDA 1
Capivasertib US FDA 1
Colestipol US FDA 1
Dinalbuphine Sebacate US FDA 1
Doxercalciferol US FDA 1
Elagolix US FDA 1
Ergocalciferol US FDA 1
Eribulin US FDA 1
Ferric Carboxymaltose US FDA 1
Fondaparinux US FDA 1
Gadobutrol US FDA 1

Also appears on these molecule pages

Abemaciclib API Anastrozole API Calcipotriol API Calcitriol API Capsaicin API Colesevelam API Colestipol API Doxercalciferol API Elagolix API Eribulin API Ferric Carboxymaltose API Fondaparinux API
Show 23 more molecule pages
Gadobutrol API Gadoteric Acid API Iloperidone API Imatinib API Lapatinib API Leflunomide API Levonorgestrel API Linezolid API Meprobamate API Mifepristone API Montelukast API Mycophenolate Mofetil API Mycophenolic Acid API Nintedanib API Orlistat API Paricalcitol API Pazopanib API Pitavastatin API Sevelamer API Temozolomide API Teriflunomide API Ulipristal API Zavegepant API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 2 None
EMA None 2
US FDA None 1

Questions about Formosa Laboratories

Does Formosa Laboratories hold a US DMF or a CEP?
Formosa Laboratories holds 51 active US drug master files and 8 valid CEPs. 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 Formosa Laboratories FDA-registered?
One site operated by Formosa Laboratories 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 Formosa Laboratories's last inspection go?
The most recent inspection on record closed on 25 July 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Formosa Laboratories manufacture?
2 registered sites are on record, in Taiwan (Taoyuan and Taiwan). Every site is listed on this page with the register it came from.
What does Formosa Laboratories make?
30 molecules are on record against Formosa Laboratories, including Calcipotriol, Calcitriol, Sevelamer and Sevelamer Carbonate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Formosa Laboratories's GMP?
Current GMP certificates are on record from EMA and 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

  • 2 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 25 July 2024.

Comparable suppliers

Hetero shares 11 molecules Cipla shares 10 molecules Dr Reddy's Laboratories shares 10 molecules MSN Laboratories shares 7 molecules Apitoria Pharma shares 7 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