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Transforming process knowledge into reliable API manufacturing through scalable operations, robust quality systems, and seamless technology transfer.
Successfully manufacturing a small molecule API requires the ability to translate process knowledge into reliable execution at scale. As programs advance toward clinical and commercial production, maintaining process performance, product quality, and supply continuity becomes critical.
With more than 1,226 kL of manufacturing capacity across three cGMP facilities and over 40 years of experience in complex API manufacturing, we support small molecule NCE programs from early-stage manufacturing through commercial supply. We also support the manufacture of intermediates and key starting materials (KSMs), helping customers strengthen supply continuity and maintain greater control over critical stages of the manufacturing process.
By integrating development, technology transfer, scale-up, and manufacturing under one organization, we help establish a seamless path from process development to long-term commercial production.
We leverage development knowledge and manufacturing expertise to establish scalable operating conditions, improve process efficiency, and support consistent product quality as production volumes increase.
As programs progress through clinical development, manufacturing requirements evolve rapidly. We support clinical manufacturing across development stages, providing the flexibility, quality systems, and technical support needed to meet changing program requirements.
Supported by more than 1,226 kL of reactor capacity across three cGMP manufacturing facilities, we provide the scale and manufacturing expertise required to support commercial supply programs worldwide.
From scale-up and manufacturing readiness to commercial production, we help transform process knowledge into dependable manufacturing execution.
Manufacturing operations are supported by established quality systems, experienced technical teams, and infrastructure designed to support complex small molecule APIs across development stages.
Beyond individual production campaigns, we support long-term manufacturing requirements through ongoing process monitoring, optimization, and lifecycle management activities.
