Asymchem’s Quality Policy assures that the development and production of active pharmaceutical ingredients (APIs) and drug products are in compliance with the standards defined in cGMP and ICH Q7/Q8/Q9/Q10/Q11, as well as 21CFR 211/210 guidelines to meet China, EU and US FDA regulatory requirements, and are fit for human consumption.
Highest Quality Standard
The culture at Asymchem is oriented on quality and following strict quality standards and meticulous quality thinking. All Aimed to help launch our client’s drug product to more than 96 countries and regions.
Our customer's success is our goal
We are devoted to help our clients quickly launch product to market, providing much needed care to patients throughout the world.
Good Regulatory Inspection Record
Since 2011，Asymchem received 10 times USFDA inspection (2011，2014，2015，2017, 2018，2019), twice Australian TGA inspection, one Korean MFDS inspection, and more than 20 Chinese NMPA inspection, all resulting in acceptable.
We have successfully hosted more than 300 worldwide customer audits.