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Drug Product Development and Manufacturing
Turning an API into something a patient can take and then making it at the scale the market needs.
Oral and injectable
A formulation R&D team of 1,500+ formulators and analytical scientists support both oral solid and parenteral dosage forms, with bioavailability enhancing technologies available from laboratory to production scale.
Oral drug products
Parenteral
Packaging, Labeling, and Supply
Three service packages
IND Enabling Pre-formulation Package — 8 to 12 weeks to an IND-ready formulation.
Fast to Clinic Supply — formulation development and clinical trial material supply both within 8 weeks.
Fast for Commercial Launch — technology transfer to release of PPQ completed in 6 months.
What we make, and where
Wuxi City, China — the integrated formulation development and manufacturing site. 12 plants covering tablets and capsules, high-potency tablets and capsules, sterile formulation, ointment and gel, with a dedicated formulation R&D center. Passed an EMA pre-approval inspection in January 2026 with no critical findings.
Shanghai Waigaoqiao, China — oral solid development and manufacturing, and injectable development.
Couvet, Switzerland — commercial oral solid manufacturing at 2 billion tablets and 250 million capsules a year, with seven late-phase and commercial projects running. A PSD-4 spray dryer comes online in Q4 2026.
Middletown, Delaware — a 190-acre North American campus. Oral solid manufacturing, packaging, labeling, distribution, and an analytical laboratory from Q4 2026, with sterile fill-finish following in Q4 2027.
San Diego, California — drug product site within the same quality system.
Across the sites, 3,800+ batches and 2,000+ shipments a year go to the United States, Europe, China, and other markets. One quality system covers all of them, approved by the major regulatory agencies.
Bioavailability enhancement
Most small molecules coming out of discovery are poorly soluble, and a conventional tablet will not deliver them. The choice of bioavailability technology is the hardest early decision in drug product, because the approaches suit different molecules and the choice has to be made on limited material.
We run spray-dried dispersion, hot melt extrusion, nano suspension, liquid capsules, and lipid nanoparticles, and screen the candidates for a molecule in parallel. More than 360 molecules a year use these technologies, 17 of them late-phase or commercial products.
Transferring a product mid-program
A change of drug product manufacturer during development brings a technology transfer and, late in development, comparability work.
One Phase 3 project transferred from the client’s own site to Couvet and reached NDA submission five months later.
Selecting the technology from the molecule
Each bioavailability technology suits a particular set of molecular properties, so the options are screened in parallel and the ones that will not work for the molecule are ruled out early.
More than 360 molecules a year go through that comparison at WuXi STA, and the recommendation for a new molecule draws on those outcomes.