Rottendorf, Corealis form alliance for end-to-end oral solid dose programs

Rottendorf Pharma, an oral solid dosage contract development and manufacturing organization headquartered in Ennigerloh, Germany, and Corealis Pharma, an early-stage oral solid dosage (OSD) development specialist based in Laval, Québec, have formed a strategic partnership to provide integrated OSD development from pre-formulation through commercial supply.

Under the agreement, Corealis will lead research and development and Phase I through II clinical supply, while Rottendorf will manage Phase III scale-up, validation, and commercial manufacturing. The companies said the model is intended to reduce scale-up risk and accelerate timelines by aligning formulation strategies, analytical methods, manufacturing processes, and regulatory expectations from early development through commercialization.

The alliance formalizes an existing collaboration and introduces a joint execution and governance framework, structured knowledge transfer, and integrated technical planning across development stages, according to the announcement.

“Through this collaboration, we provide our biotech clients a continuous transition from early-stage development to commercial supply — with seamless knowledge transfer,” Corealis Pharma CEO David Leroux-Petersen said in a statement.

In a separate recent development, Corealis entered a strategic alliance with Bora Pharmaceuticals to create an end-to-end OSD pathway linking early formulation and clinical-scale development with commercial production under a unified project and quality framework, according to the companies.