LEGANÉS, Spain — Global contract development and manufacturing organization (CDMO) Recipharm has announced a significant expansion of its high potency active pharmaceutical ingredient (HPAPI) manufacturing capabilities at its facility in Leganés, Spain. The move introduces GMP pilot-scale production, effectively creating a seamless, single-site pathway for pharmaceutical companies to transition their high-potency programs from early-stage development through to full commercial manufacturing.
As the pharmaceutical industry sees a surge in complex drug development—particularly in the oncology and rare disease sectors—the demand for specialized high-containment infrastructure has reached a critical inflection point. Currently, the industry faces a supply bottleneck, as the construction of new, compliant high-containment facilities typically requires more than two years to complete.
“High potency compounds are a fast-growing part of the industry’s pipeline,” said Greg Behar, CEO of Recipharm. “By extending our capabilities at Leganés, we are moving ahead of that demand. Customers can now bring their high-potency programs to one partner, allowing for a streamlined progression from the first pilot batches all the way to commercial supply, ultimately helping them get these life-saving medicines to patients sooner.”
The new pilot-scale suite centers on dry granulation technology, a manufacturing approach specifically chosen for its safety and efficiency in handling high-potency substances. Because dry granulation is solvent-free and avoids the use of heat or moisture, it ensures superior API stability while significantly enhancing containment integrity and operator safety. Furthermore, the process is highly efficient, minimizing the waste of scarce or expensive raw materials.
To further optimize the development process, the facility has integrated Recipharm’s proprietary “ReciPredict” platform. By utilizing advanced material science, predictive modeling, and simulation, the platform allows clients to fine-tune formulation and process designs. Recipharm estimates that this integration can reduce API consumption by up to 70% during the critical development and scale-up phases, providing a substantial economic advantage for developers working with costly, limited-supply compounds.
These new pilot capabilities augment the site’s established commercial infrastructure, which is already equipped to handle compounds up to Occupational Exposure Band (OEB) 5 with an annual production capacity of approximately 250 tons. The Leganés facility maintains a robust regulatory footprint, holding approvals from the U.S. Food and Drug Administration (FDA), AEMPS (EU GMP), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
In addition to HPAPI production, the site offers comprehensive services including the manufacturing and packaging of conventional and film-coated tablets and capsules, supported by full serialization services and on-site quality control laboratories. By integrating pilot and commercial scales under one roof, Recipharm aims to mitigate the logistical risks associated with tech transfers, offering clients a faster, more flexible route to market in an increasingly competitive pharmaceutical landscape.
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