ESTEVE CDMO invests $80m in new China API manufacturing site

The Shaoxing facility will provide 250 m³ of reaction volume, with potential capacity exceeding 400 m³, as the CDMO expands its global small-molecule API manufacturing network

Spanish pharma company ESTEVE is investing more than $80m to relocate, expand and modernise its contract development and manufacturing organisation (CDMO) operations in China.

Located in Shaoxing, the new manufacturing site will strengthen ESTEVE CDMO’s capacity to support pharmaceutical customers in China and across Asia, while integrating its regional operations more closely with its global manufacturing network.

The facility comprises three manufacturing workshops with a total reaction volume of 250 m3, with infrastructure and space reserved for an additional 150 m3 or more.

This could bring total reaction volume to more than 400 m3 as demand grows.

Automation and digitalisation technologies have been incorporated throughout the site to support operational efficiency, manufacturing flexibility and scalability.

A centralised control centre, warehousing facilities and dedicated infrastructure for future expansion are also included in the development.

Expanding small-molecule API capabilities

The investment builds on ESTEVE CDMO’s presence in China, which dates back to 2000 and forms part of its strategy to develop an integrated international manufacturing platform.

The company’s global technology offering includes spray drying and high-potency active pharmaceutical ingredient (HPAPI) manufacturing, supporting the development and production of increasingly complex small-molecule APIs and pharmaceutical intermediates.

The new Shaoxing site is intended to bring these capabilities closer to customers in Asia while complementing manufacturing operations across Europe and the Americas.

The facility's design also incorporates environmental, health and safety considerations.

The site has achieved a ‘Very Good’ rating under the Building Research Establishment Environmental Assessment Method (BREEAM) and has been selected as a candidate for the BREEAM China Awards.

Further investment in global manufacturing

The China expansion follows a series of investments by ESTEVE CDMO this year as it develops its international manufacturing footprint.

In September, the company announced a further $17.5m investment in its Morton Grove facility in Illinois, bringing total announced investment at the US site to $33m.

The expansion includes two new 500-gallon reactors, enhanced containment capabilities in early-stage development laboratories and warehouse upgrades.

The Morton Grove facility combines process research and development, analytical and stability testing, cGMP API manufacturing and CMC support.

Together, the investments in China and the US are intended to strengthen ESTEVE CDMO’s ability to support pharma partners from early development through to larger-scale manufacturing.

The company said the Shaoxing project also reflects its long-term commitment to developing local expertise and industrial capabilities in China, while connecting its regional operations with the technologies and experience of its wider global organisation.

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