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Rottendorf Pharma Alliance

A Transatlantic Pathway for Oral Solid Dose Programs, Built to De-Risk Scale-Up by Offering Seamless Development and Manufacturing Services

Integrated early-development offering and accelerated commercial pathway for Biotech companies

Corealis Pharma has entered into a strategic partnership with Rottendorf Pharma, a globally recognized CDMO with decades of expertise in late-stage development, European regulatory readiness, and commercial manufacturing of oral solid dosage (OSD) forms. Together, we offer biotech and pharmaceutical innovators an integrated, end-to-end development-to-commercial model—linking North American early-phase development and clinical supply with European Phase III scale-up, drug registration support, and long term market supply.

Key Value Blocks

Speed through continuity

Minimize handoffs and compress timelines with an aligned path from early development through commercial readiness, which is supported by joint teams and coordinated execution.

Simplicity with deep OSD expertise

Access best-in-class OSD capabilities on both sides of the Atlantic without managing multiple disconnected partners.

Technical confidence for scale-up

Reduce transfer risk through early alignment on formulation strategy, manufacturing approach, analytics, and documentation, providing for a smoother transition to Phase III and commercial validation.

What This Alliance Enables

This collaboration is designed for clients who wants to explore commercializing in Europe and beyond, while maintaining a strong North American early-phase foundation. The alliance supports:

  • Early integration of commercial manufacturing expectations into formulation and process development
  • Equipment and methodology alignment to reduce scale-up and validation risk
  • Seamless transition from North American clinical development to European Phase III and commercial manufacturing
  • Regulatory-ready documentation and quality systems that support EU and global filings
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A Transatlantic Model Built for Biotech

Emerging and mid-sized Biotechs often need speed and flexibility early, as well as confidence that their program can easily scale into late-stage and commercial supply. Corealis Pharma remains your entry point for pre-formulation, formulation development, analytical support, and clinical trial manufacturing in North America, while Rottendorf Pharma provides a preferred European pathway for Phase III scale-up and commercial manufacturing, supported by teams experienced in European registration expectations.

How We Work Together

To reduce friction and risk across the lifecycle, Corealis and Rottendorf collaborate through structured technical coordination, including joint project engagement, planned data exchange, and transfer-ready documentation. This approach helps ensure continuity of knowledge, clearer decision-making, and smoother progression toward commercial readiness.  Clients can engage either organization independently or utilize the combined pathway based on program needs.

About the Alliance

Corealis Pharma Inc. is a privately held, GMP-compliant CDMO based in Laval, Québec, Canada. Specializing in oral solid dosage forms, Corealis provides customized formulation development, analytical, and 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.

 

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.

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Contact Corealis

Corealis’ experts are ready to answer any queries about the company’s oral solid dose offering, including its development and manufacturing capabilities.

Contact Corealis