By Will Chu, Editorial Team 24/7 Biopharma
In a climate of increased regulatory hurdles and disruption across global supply chains, Ofichem is marking its 50th anniversary with a shift toward wider expansion, through targeted acquisitions, reinforcing its end-to-end development model, and prioritising valued partnerships.
At this year’s CPHI in Frankfurt, the manufacturer celebrated half a century of API development, discussing recent purchases of the Avivia formulation business in Nijmegen, Netherlands and a former Recipharm facility in Uppsala, Sweden in moves that build Ofichem’s technological capabilities and geographical reach.
Speaking to 24/7 BioPharma, business development executive Marinus Bouma said the acquisitions, “represented possibilities in pre-clinical chemistry, analytical services, all non-GMP. So the opportunities are limitless there with very short lead times.”
“Our end-to-end service offering supports customers in shorting development timelines, bringing products fast to market and make use of Ofichem’s technical problem solver skills… We carry out formulation development, research support and traditional CMO business”
“The takeaway for us is getting visibility, expanding the network, offering additional service solutions to existing and new customers … as part of the Life Science industry.”
Strengthening supply chains
Founded in 1975, Ofichem has grown from a small Dutch API producer into a multi-facility group spanning the Netherlands and Sweden.
Over time, Ofichem’s API operations have integrated a sourcing arm that stockpiles Asian-made APIs to stabilise customer supply chains.
The company recently underscored its position within a broader shift back toward European manufacturing, noting that tightening regulation, supply-chain re-shoring and renewed scrutiny of Asian sourcing have accelerated demand for EU-based CDMOs.
They also previously commented on the industry’s push for higher quality standards and greater supply-chain robustness that plays directly to the strengths of mid-sized European producers with established analytical capabilities and long-standing regulatory experience.[1]
“You see that whatever type of market there is, regulatory gets stricter,” explained Bouma. “And as a European CDMO or European supplier, we know exactly what is needed and we are really one step ahead of the curve there.”
Pragmatic commercial approach
Against this backdrop of regulatory tightening and shifting supply priorities, the company’s commercial approach remains deliberately pragmatic.
On therapeutic focus areas, Ofichem explained that it largely followed market pull rather than prioritising specific disease categories.
“We make small molecules,” Bouma said acknowledging that “there is a little bit more demand for dermatology, ophthalmology, CNS, and in pre-clinical world, it’s still oncology.”
The greater challenge, he suggested, was in forecasting against a geopolitical backdrop that complicated planning.
“Because of [the] geopolitical situation, we don’t really know what’s going on… We keep our eyes very much open, and we keep close to the market to understand as much as possible what’s best for the near future.”
European focus
That uncertainty has pushed supply-chain resilience to the forefront of its strategy, prompting Ofichem to leverage an in-house sourcing unit as a buffer for customers.
“We actually have a business unit which sources and distributes APIs. So we source from Asia, we stockpile in the Netherlands, and we can use that to de-risk everything for the supply chain for our customers. It’s a very big issue nowadays.”
This approach echoes similar moves in the industry, as European regulators and pharma companies such as Sanofi and Novartis shift to localise or at least diversify API supply after pandemic-era shocks.
CDMOs including Siegfried and Lonza report rising demand for European stockpiling and split-site manufacturing, and companies such as Rovi and Cambrex have added regional small-molecule capacity to meet this shift toward localisation.
Regulatory-wise, the European Commission’s Critical Medicines Act offers incentives for repatriating production of essential APIs.
France has imposed minimum safety-stock requirements and Germany has proposed tenders favouring EU-based suppliers further accelerating the move toward diversified, European-centred supply chains.
Analytical Strengths
Bouma also highlighted Ofichem’s analytical strengths, noting the company’s ability “to understand exactly if there is any impurity or any risk… basically any type of risk that could [appear] in our products.”
Environmental considerations play a larger role in shaping Ofichem’s process development investment. Bouma pointed to ongoing implementation of flow chemistry: “At our API site, we are implementing flow chemistry as a green alternative to batch chemistry.”
Looking ahead, Bouma saw particular promise in the orphan-drug segment, where commercial volumes remain modest, but quality demands are high—a niche well suited to smaller, more flexible manufacturers. “We see a lot of orphan drugs… The batch size… fits our size very, very well.”
As the global API sector prepares for continued volatility, Ofichem’s strategy appears to hinge on staying nimble without abandoning the attributes of stability, trust, and the understated advantages of remaining family-owned in a consolidating industry.
