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Commercial Drug Product Manufacturing
Commercial oral and injectable manufacturing at launch volume, and at the small volumes an orphan or narrow-market product needs.
Capacity
Our annual oral capacity is more than 10 billion doses, and parenteral runs to more than 100 million units across five aseptic filling lines.
That platform covers the whole commercial range. A high-volume product has the capacity for a launch that runs ahead of forecast and for the markets added after it. A product with a modest forecast, an orphan indication or a narrow launch market, runs at the batch sizes it needs, under the same quality system.
Validation
65 new chemical entities taken through drug product validation, and 17 commercial products in supply. Validation is where formulation and process decisions made years earlier are tested at scale, which is why most of the work behind it is done in late-phase development.
Where commercial products are made
Couvet, Switzerland — 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, bringing spray-dried dispersion to commercial scale in Europe.
Wuxi City, China — 12 plants covering tablets and capsules, high-potency oral solids, sterile formulation, ointment and gel. Passed an EMA pre-approval inspection in January 2026 with no critical findings.
Middletown, Delaware — oral solid manufacturing, packaging and distribution from Q4 2026, sterile fill-finish from Q4 2027.
Our drug product sites have been inspected by regulators in the United States, the European Union, China, Japan, South Korea, the United Kingdom, Brazil, Switzerland, Australia, New Zealand and Canada.
High-potency commercial supply
Contained manufacturing at an occupational exposure limit of 10 ng/m³, at 1.1 billion doses a year for oral solids and 25 million vials for injectables. Potent products run inside the same quality system as the rest of the network.
Lifecycle management
Products change after approval: a new market with different packaging requirements, a second strength, a process improvement worth filing.
Commercial supply as a routine operation
The aim in commercial supply is that it needs no attention from the sponsor: batches release on schedule, markets are supplied, and post-approval changes go through without interrupting either.