Introduction
Chemspec-API provides comprehensive services for the development and cGMP manufacturing of active pharmaceutical ingredients (APIs) and pharmaceutical intermediates.
Established in 1997 and operating in Fairfield, New Jersey, Chemspec-API has successfully completed multiple U.S. FDA inspections. Through seamless access to resources at our parent company, Shanghai Chemspec Corp., we enable clients to optimize costs while maintaining U.S.-based quality standards and a reliable supply chain.
Company Milestones
1997
API Inc. was founded in New Jersey, supplying three generic APIs to the European market.
2001
Successfully completed the first U.S. FDA inspection.
2010
Relocated to the current facility in Fairfield, New Jersey.
2015
Installed the first ISO–7 Classified Cleanroom.
2018
Acquired by Shanghai Chemspec Corp.
2023
Parent company, Shanghai Chemspec Corp., was listed on the SSE STAR Market.
2025
U.S. FDA approval for the first client API taken from preclinical development to commercial launch.