History

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Chunghwa Chemical Synthesis & Biotech Co. Ltd.,(CCSB) is the first company which got FDA approval to produce synthesis and biotechology API products in the South-East Asia.

 
2022

CCSB obtains Outstanding Company of the year, 2022 Taiwan BIO awards. CCSB obtains Taiwan patent fro Ethyl Icosapentate and Etelcalcetide.

2021

US FDA approved customer’s ANDA of Icosapent Ethyl. CCSB invests NTD500,000,000 for biotechnology manufacture plant, including fermentation and purification equipment. 
2020

CCSB completes the inspection by TFDA (Taiwan Food and Drug Administration) in Aug.

 

 

  
 

2019

CCSB celebraties its 55th anniversary.

2018

CCSB obtains TW patents, crystal form D of Baricitinib phosphate (I 616447) and a method for preparing amorphous Carfilzomib (I 636052), respectively. A second time honors to receive Gold Medal Award for the "Manufacturing Technology", co-hostes by the Ministry of Health & Welfare and the Ministry of Economic Affairs. The award-winning product is Caspofungin Acetate. CCSB completes the inspection by US FDA (Food and Drug Administration) in November.
2017

Obtain US Patent "Process for Producing Diamine Derivative (US9809546 B2) " for Edoxaban Intermediate in November, TW patent (I 671460) in February as well. Obtain TW patent “Method of preparing glucagon-like peptide 2(GLP-2) analog” (I 591177) for Teduglutide in July. Obtain TW patent “Process for preparing intermediate compound of Ixazomib Citrate, and Ixazomib Citrate made thereby” for Ixazomib citrate intermediate in September.
2017 Obtain Taiwan Patent "Process for Production Diamine Derivative (I 671460)" for Edoxaban Intermediate in February.
2016 Dr. Hung-Yuan Cheng, Vice President of R&D Division, retired in March. Obtain certificate of ISO50001 in December. Obtain the Gold Medal Award for the "Manufacturing Technology" item of the R&D Award of Pharmaceutical Technology co-hosted by the Ministry of Health & Welfare and the Ministry of Economic Affairs in December, the award-winning products are MMF and EVE. 
2015 Partial sale of the land in Taoyuan High-Tech Park in January. Pravastatin Sodium & Tacrolimus got approval from German GMP in March. Dr. Steve H. Chang retired, and Dr. Chih-Ping Yang be appointed President in May. 
2014 Dr. H.Y. Cheng has been promoted to Vice President of R&D Division in March. Got approval from FDA again in May. Obtain US Patent for method for preparing Ridaforolimus in June 2014. Obtain Taiwan Patent for method for preparing Ridaforolimus in July 2014.
2013 Obtain Mycophenolic Acid (MPA) Sodium preparation process patent from TIPO (Taiwan Intellectual Property Office) on January 2013. Olopatadine and Rapamycin have passed an inspection by the TFDA (Taiwan Food and Drug Administration) on May 2013. In the same year, Tacrolimus has passed the audits by both PMDA (Pharmaceuticals Medical Devices Agency, Japan) and MFDA (Ministry of Food and Drug Administration, Korea) on June and September, respectively. In mid-Oct, Everolimus and Caspofungin have passed an inspection by the TFDA (Taiwan Food and Drug Administration).                                                  
2012 Obtain Taiwan Patent for Temsirolimus and Process for making Biolimus A9, Purchase land in Taoyuan High-Tech Park for expanding plan, Everolimus be launched, Ethyl Icosapentate be launched, Got approval from German GMP in late May, Obtain US Patent for Process for preparation of Temsirolimus, Obtain Taiwan Patent for Caspofungin.
2011 Got approval from FDA again in April, Obtain US Patent for Process for making Biolimus A9.
2010 Publicly listed on December 20, 2010. 

2009 Got approval from German GMP in late June; Business volume of Mycophenolate Mofetil over NTD 500 millions; List on OTC successfully in October.
2008 Mycophenolate Mofetil be stably exported to US market, and the business volume of which over NTD 200 millions.
2007 Trandolapril、Olopatadineand Perindolpril be toll manufactured; Contract manufacturing items increased, and the business volume of which targeted 25% of total sales.
2006 Carisoprodol be launched; Tacrolimus be stably exported to US market; Business volume of Pravastatin over NTD 200 million.
2005 Rapamycin be stably exported to US market ; Got approval from FDA again for both Synthesis & Biotechnology cGMP plants in December.
2004 Rapamycin be commercialized; Tacrolimus be launched; Dr. I-Der Hunag retired, and Dr. Steve H. Chang be appointed President.
2003 Cooperated with Europe Pharmacist to mutually develop Trandolapril & Perindopril; Mycophenolate Mofetil be commercialized; Methocarbamol took the largest share in US market; Company name be changed as Chunghwa Chemical Synthesis & Biotech Co., Ltd.; Reached profit for the first year after company transformed; Export sales targeted nearly 90% of the annual business turnover.
2002 Got FDA approval for the Synthesis cGMP Palnt; Got approval from BFDA (Bureau of Food and Drug Analysis, Department of Health).
2001 Dexbromopheniramine maleate and Methocarbamol are launched.
2000 Pravastatin is commercialized; Rapamycin、Mycophenolate Mofetil and Alprazolam are launched .
 
1999 Construction of 4 new cGMP plants completed; US Sales Office formed; Famotidine is launched. 
1998 Mr. Derek Wang is appointed Chairman; Construction of 2 new Biotech cGMP plant started; Fluoxetine is launched.
1997 Dr. I-Der Huang is appointed President; Partnership with China Development Industrial Bank (CDIB); Construction of 2 new Synthesis cGMP plants started; Fluconazole is launched.
1995 Calcium Polycarbofil, Melatonin & Glibenclamide are launched
1994 Construction of waste treatment plant completed; Glipizide & Nifedipine are launched.
1992 Mr. Xie-Xiong Tsai be appointed President; Cefatrizine is launched.
1991 Norfloxacin & Flumequine are launched.

1990

 Construction of Research Center started; Research Operations for Synthesis, Biotech and Formulation started; Invest San-Ta Pharmaceutical company for production GGE & SSG.
 
1986 6-APA production plant completed.
1984 Cefadroxil is launched; Got approval from FDA and became the first authorised company to produce API in the South-East Asia.
1983 Rifamycin is launched.
1982 Cefalexin is launched.
1981 Erythromycin Estolate is launched.
1980 Amoxycillin is launched.
 
1975 2nd Production plant completed for production Penicillin derivatives product; Ampicilin & Cloxacillin are launched.
 
1969 Thiamine Propyl Disulfide is launched.
1967 Acetaminophen, Bucetin is launched.
1966 1st Production plant completed.
1965 45,800㎡ production site purchased.
1964 Mr. Ming-Ning Wang found CCSB, Chloramphenicol and loropheniramine Maleatebe launched.