History & Milestones

1964

Company founded; launched its first products, including Chloramphenicol.

1975–1980

Constructed penicillin-derivative manufacturing facilities; introduced Ampicillin and Amoxicillin.

1984

Became the first GMP API manufacturer in Southeast Asia to pass a U.S. FDA inspection.

1990

Established R&D center; initiated development of biotech and formulation products.

1997–1999

Constructed multiple cGMP manufacturing plants; established U.S. sales office; expanded into global markets.

2002

cGMP plant passed both U.S. FDA and Taiwan FDA inspections.

2003

Renamed as Chunghwa Chemical Synthesis & Biotech Co., Ltd.; achieved profitability in the first year of transformation.

2005–2012

Supplied multiple products steadily to the U.S. market; obtained patents in Taiwan and the U.S. for APIs including Rapamycin, Temsirolimus, and Caspofungin.

2012

Established the Analytical Research Institute to expand R&D capabilities.

2013–2017

Multiple products passed GMP inspections by Taiwan FDA, Japan's PMDA, and German authorities; secured patents for molecules such as Ixazomib and Edoxaban.

2016 & 2018

Twice honored with National Pharmaceutical Technology & Research Development Award, NPRDA Gold Medal Award in Manufacturing Technology.

2018

Successfully passed full-facility inspection by the U.S. FDA.

2019

Celebrated 55th anniversary; obtained a new crystalline form patent for Ribociclib.

2020–2021

Expanded fermentation production capacity; clients received U.S. ANDA approvals.

2022

Received two Taiwan patents and awarded as Outstanding Company of the Year.

2024

Celebrated 60th anniversary; passed international GMP inspections by Taiwan FDA, PMDA, U.S. FDA, and German authorities. As Cerna Inc.'s affiliates Chunghwa Chemical Synthesis & Biotech Co., Ltd.