PHARMA SPECIAL
Esteve is planning a major expansion in China
and RSMs but not APIs, with GMP manufacture at Bharuch.
“ We have a big pipeline of projects and have been developing and manufacturing a large number of molecules with innovators at different stages of the life cycle, though a significant chunk of them are in Phase II-III,” Jain said. The company now operates ten multi-purpose plants and two pilot facilities across its India sites, with more than 200 reactors and over 2,000 KL of total capacity for handling hazardous reactions.
Small is still beautiful
For all the attention on novel modalities and large molecules— leaving aside the facts that some peptides are actually small molecules while some small molecules are rather large— all of the CDMOs said that their small molecule businesses were strong. As CordenPharma’ s Houldsworth noted, 68 % of the drugs approved by the US FDA in the first three quarters of 2026 were small molecules.
Another key trend is that API synthesis of all molecules is becoming ever more complex. Where there were three to five steps 20 years ago, now there might be 15 to 20, according to Neuland’ s Davuluri. Some of the company’ s RSMs require ten to 15, including multiple chiral centres, polymorphism, deuterisation and much more.
Mike Riley, CEO of Veranova, echoed many others by highlighting two continuing market trends. One is growth in demand for small molecules with complex processing requirements, such as crystallisation, and for HPAPIs and ADCs, driven above all by oncology indications.
Tied in with this, Riley said, companies are looking for US-based supplies in order to secure their supply chains.“ This will create opportunities for companies like us because small molecule capacity is not extensive in the US, particularly for high potency and specialised capabilities,” he said.
Addressing this trend, Veranova will bring new capacity onstream at its site in Devens, Massachusetts, by the end of the year. This includes a process development laboratory, two cGMP HPAPI suites capable of handling up to OEB6, bioconjugation development and cGMP manufacturing. This will further enhance its position in ADC linkerpayloads, an area in which it has been active for over 20 years.
Further investments
Shortly before CPHI, Esteve CDMO approved a $ 17.5 million investment at its site in Morton Grove, Illinois, bringing the total his year to $ 33 million. This will include two new 1,900L reactors, enhanced laboratory containment capabilities and a warehouse revamp. The stated aim is to increase flexibility in early development and expanding manufacturing capacity as programmes progress toward larger clinical and commercial requirements.
This was dwarfed, however, by a subsequent announcement of an $ 80 million investment to relocate, expand and modernise its operations in China, where it has been active since 2000 and offers technologies including spray drying and HPAPI manufacturing for the Chinese and wider Asian markets. The company will open a new site in Shaoxing, featuring three manufacturing workshops with a total volume of 250 m ³, plus the space to add 150 m ³ as demand grows.
Complex chemistry also informed a transaction that emerged at CPHI Milan. Italian CDMO Flamma revealed that it has agreed to acquire Lundbeck Pharmaceuticals Italy( LuPI) from Danish firm H. Lundbeck. The deal should close on 1 January 2027, subject to customary closing conditions. Terms were not disclosed.
Flamma said that this advances its“ long-term strategy of building a differentiated global CDMO platform focused on complex small molecule APIs, as well as high-value amino acids and peptides”. Lundbeck will continue to manufacture small molecules at its facility in Lumsås, Denmark.
LuPI’ s facility in Padova has 220 m 3 of capacity, increasing Flamma’ s total to about 1,100 m 3 at four sites. Key capabilities there include an AIFA-approved API workshop, hydrogenation, micronisation, highpressure chemistry, hazardous chemistry and high-containment manufacturing. ●
Riley – Demand for US-based supply will benefit Veranova
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