Home / Small molecules / Drug substance
Small Molecule API Development and Manufacturing
From the first GMP batch to commercial supply, with the same team and the same process knowledge carried the whole way.
What each stage demands
A first-in-human campaign and a validation batch call for different work. In early development, speed and flexibility matter most, because the molecule may not survive the clinic. In late development the process has to be defensible to a regulator and reproducible for years.
Development
Manufacturing
Commercial
Process Enabling Technologies (Small Molecules)
Our expertise
We have built extensive expertise in small molecule drug substance development and manufacturing with more than 3,000 process chemists across 8 global sites, ensuring seamless progression.
We provide API process R&D and manufacturing, including specialized capabilities for handling high potency APIs (HPAPIs).
With state-of-the-art facilities and a proven global quality system, our experience delivers reliable and high-quality drug substances to meet your needs.
What sits behind your molecule
Scale matters in drug substance for one reason: a molecule that reaches the market has to be supplied for a decade or more, and the people who developed the process should still be the people running it.
- 3,500+ scientists across 33 plants
- More than 4,000 m³ of total reactor volume
- 39,000+ drug substance batches a year
- Sites in North America, Europe and China, with Singapore scheduled for 2027
The inspection record
Since 2023, the US FDA and EMA have waived more than 30 pre-approval inspections of our sites. A waiver means the agency approved the application without a site visit.
Those waivers sit on a record of 20 US FDA inspections since 2013, 12 EMA inspections since 2009, 95 from China’s NMPA, 17 from Japan’s PMDA, and more than 450 client audits a year. More than 1,000 CMC submission packages have been written since 2019 to support global IND and NDA filings, supporting approvals in more than 100 countries.
Starting from routes that have already been run
Every API process is new, but its parts rarely are: the reactions have been run, the impurity classes have been characterized, and the scale-up failure modes are a known set.
Route work at WuXi STA starts from that record, so a first proposal is built on reactions and isolations that have already been run at scale.