Rottendorf Pharma and Corealis Pharma have expanded their service offering through a strategic partnership. The collaboration offers pharmaceutical and biotech companies a strategic transatlantic alliance designed to simplify and de-risk the end-to-end OSD journey by extending and integrating complementary development capabilities from pre-formulation to global market supply.

This new partnership now formalizes and extends an existing collaboration towards the development-to-commercialization model built on early technical integration of material, equipment and process consistency, and structured knowledge transfer. This enables biotech and pharmaceutical companies to move confidently and rapidly from pre-clinical and early clinical phases at Corealis  through all subsequent development stages and into Phase III scale-up and market registration in the US, Europe, and beyond at Rottendorf. Corealis and Rottendorf operate under a joint execution and governance framework, aligning formulation strategy, analytical methods, manufacturing processes, and regulatory expectations from the earliest stages of development. This approach reduces scale-up risk, accelerates timelines, and strengthens readiness for commercial by progressively integrating development and manufacturing considerations throughout the program. “With Corealis, we have gained an ideal partner for early-stage development who complements our own expertise and expands our reach in this area”, says Erich Scheibner, Managing Director at Rottendorf Pharma. “Together, we offer our customers an integrated yet flexible solution that combines scientific excellence, quality, and reliability across the entire development continuum.”

“Rottendorf brings decades of experience in late-stage development, scale-up and commercial manufacturing of oral solid dosage forms,” adds David Leroux-Petersen, CEO of Corealis Pharma. “Through this collaboration, we provide our biotech clients a continuous transition from early-stage development to commercial supply – with seamless knowledge transfer.”

Built for speed, simplicity, and technical confidence, the alliance operates through a structured framework for data exchange, tech-transfer dossiers, and joint project teams that integrates commercial manufacturing and late-stage development requirements early into formulation and process development, aligns materials, equipment and methodologies to reduce scale-up and validation risk, and enables a seamless transition from North American clinical development to Phase III and commercial manufacturing in Europe.

Rottendorf Pharma is one of the leading contract manufacturers and developers in the field of solid oral dosage forms. As a CDMO (Contract Development and Manufacturing Organization), Rottendorf Pharma is active in the manufacture and packaging as well as the development of formulations and analytical processes for the international pharmaceutical industry. The company manufactures a wide range of original drugs, producing more than 5 billion tablets annually. Its customers include large, small, virtual, and global pharmaceutical and biotechnology companies. Rottendorf Pharma does not market its own products and therefore never competes with its own customers. Rottendorf Pharma employs more than 1,400 people. The company was founded in Berlin in 1928 by Andreas Rottendorf. Since 1949, the headquarters for production and administration has been located in Ennigerloh in the Münsterland region, the home of the company’s founder. The company has been foundation-managed since 1974, with the Rottendorf Foundation supporting charitable causes. Rottendorf Pharma has been represented in the USA since 2011.

Corealis Pharma Inc. is a GMP-compliant CDMO based in Laval, Québec, Canada. Specializing in oral solid dosage forms, Corealis provides customized formulation development, analytical, and Phase I/II clinical manufacturing services for biopharmaceutical companies worldwide. Known for its flexibility, scientific expertise, and quality-driven approach, Corealis is a trusted partner in the development of complex drug products. Learn more at www.corealispharma.com.