2023
- TFDA’s inspection on our new Plant H, with expanded capacity for polymer products.
2022
- Passed GMP inspection by TFDA for the cytotoxic/high potency injectable production line.
- Passed 8th US FDA inspection, PAI for Mycophenolate Mofetil API and PoAI for Sevelamer Carbonate API combined.
2021
- Passed GMP inspection by TFDA for packaging and labeling of medicinal products.
- Passed GDP inspection by TFDA for medicinal products.
2019
- Formosa Pharma files IND with US FDA for APP13007, an ophthalmic treatment for post-ocular surgery pain and inflammation.
2018
- Passed 5th PAI for Taltirelin and TS-1(Gimeracil, Oteracil, Tegafur)) by PMDA of Japan.
- Formosa's customer in mainland China get the 1st Montelukast GQCE approval in Chinese mainland.
- Passed 7th US FDA inspection, a combined surveillance inspection and PAI for Sevelamer Carbonate and Colesevelam Hydrochloride
2017
- Formosa Pharma acquired Activus Pharma, a subsidiary of Sosei Group.
- Passed 6th US FDA inspection, a PAI for Sevelamer Carbonate.
2015
- Passed the 5th US FDA inspection, a general GMP inspection.
- Passed 3rd PAI for Linezolid by PMDA of Japan.
- Commenced Phase I Clinical Trial of MPT0E028 which is co-developed with TMU.
- Passed 4th PAI for Maxacalcitol by PMDA of Japan.
2014
- Obtained ISO14001, OHSAS18001, and CNS15506 certificates.
2013
- Passed joint GMP inspection by EDQM and BGV Hamburg.
- Passed 2nd PAI for TS-1 (Gimeracil, Oteracil, Tegafur ) and Taltirelin by PMDA of Japan.
- Passed 2nd PAI by COFEPRIS of Mexico for 11 APIs.
2012
- Passed the 4th US FDA inspection, the general GMP inspection.
- Filed CN DMF of Temozolomide (Total 15 API's filed, 4 out of 15 is now used in CN formulations)
2011
- Successful IPO launch.
- Currently listed in Taiwan Stock Exchange (stock code: 4746).
2010
- Incorporated brand new RD, QC & QA facilities, including an automated warehouse.
- Passed 1st PAI for Mycophenolate Mofetil by COFEPRIS of Mexico.
- The establishment of subsidiary, Formosa Pharmaceuticals, Inc.
2009
- Commissioning of facilities for high-potent APIs.
- Passed 1st PAI for Gadodiamide by PMDA of Japan.
- Passed 3rd PAI by US FDA for 7 APIs (2 NDAs and 5 ANDAs).
- Obtained COS certificate of Calcipotriol Anhydrous. ( Total 6 CEP certificates)
2008
- Merged with LC United Chemical Corporation.
- Filed Japan DMF (JMF) of Gadodiamide hydrate. (Total 14 API's filed; 14 out of 14 are now used in JP formulations.)
2007
- Passed 1st GMP inspection by BSG of Hamburg, Germany.
2006
- Passed 2nd PAI by US FDA for Avobenzone.
2004
- Passed 1st PAI by US FDA for Leflunomide API.
2002
- Filed US DMF of Leflunomide. (Total 49 API's filed, 26 out of 46 are now used in US formulations.)
- Signed supply agreement with Roche Vitamins for the production and supply of UV filters.
- Inspected by TFDA. (GMP certificates on 46 products have been granted.)
2001
- Filed EU DMF of Alfacalcidol and Calcitriol. (Total 17 API's filed, 11 out of 17 are now used in EU formulations.)
2000
- Started cGMP production of API's.
1995
- Founded by Dr. C. Y. Cheng as a contract research laboratory.