Our technological expertise is in Product Performance

Rottendorf eliminates the need for customers to provide expertise on product technology and technical operations as we fully understand the galenical design of the product and all critical parameters during technology transfer. We provide the technical expertise that is needed to solve design-based product problems by identifying process improvement potential and corresponding solutions, and successfully providing technical troubleshooting for all product and manufacturing related issues.


Development Phase of the Product Life Cycle

Rottendorf Pharma designs and develops solid dosage formulations from 2 kg to 150 kg in our state-of-the-art Development Center that is both GMP compliant and FDA approved – something not all CDMOs can offer. Technology for hot melt extrusion, hot melt granulation, and the development and production of pellets is available. Special emphasis is placed on the improved availability of poorly soluble APIs.

Customers can choose from individual or complete services including process and formulation optimization, up-scaling, clinical trial manufacturing, analytical method development, stability studies, and regulatory support. Our development expertise is grounded in the knowledge of commercial manufacturing operations and requirements. We formulate with the end in mind by delivering formulations that are ready to be easily and robustly manufactured on a commercial scale.

  • Single point of contact for customers
  • High technical and pharmaceutical expertise
  • Strong project-management skills
  • Dedicated project team for development, up-scaling and CTM supply
  • High flexibility to support customer needs
  • Tailor-made customer solutions
  • Development, up-scaling and CTM supply on the same equipment with dedicated development staff
  • Strong technical expertise
  • Efficient in providing solutions and troubleshooting
  • Reliable and on-time CTM supply
  • Analytical method development, validation and release testing
  • Short development to clinical trial manufacturing timelines
One-Stop Service
  • GMP and FDA approved environment
  • Complementary equipment for development, up-scaling, and commercial manufacturing
  • All technologies for development of solid dosage forms available
  • Focused on robust manufacturing process from formulation development until commercial manufacturing
  • Short development timelines
  • Cost-effective
  • Low risk of failure from development to commercial
Best-In-Class Development Center

Phase of the
Product Life Cycle

Development Service
  • Process and Formulation Design
  • Process and Formulation Optimization
  • Process Up-Scaling
  • Clinical Trial Manufacturing
  • Commercial Manufacturing at Small Scale
  • Analytical Method Development
  • Stability Studies
  • Regulatory Support
Development Center
  • Project Manager
  • Expert Formulation Development
  • Manager Analytical Development
  • Pilot Plant
  • In-Process Control

The Highest Level of
Technological Expertise

State of the Art


Product Performance



  • Bohle Free Fall Blender (0.5-400 Liter; max. 150kg)
  • Lödige High Shear Mixer (5, 10, 20, 130, 300 Liter; max. 100kg)


Product Performance



  • Fluid Bed Granulation: Glatt GPCG 3 (1-5kg), Aeromatic MP3/4 (10-50kg)
  • High Shear Granulation: Diosna P1, P4, P10, P 25, P60 (0.2-25kg)
  • Roller Compaction: Gerteis Roller Compactor
  • Pelletization: Nica Extruder E140, Spheronizer S450


Product Performance

Hot Melt Granulation


  • Vacumix Melting and Blending Equipment
  • Aeromatik MP3/4 (10-40kg)


Product Performance

Hot Melt Extrusion


  • Leistritz Twin Screw Extruder, Type: ZSE 18-HPE, screw diameter 18mm
  • Thermo Fischer Pharma 11mm Extruder


Product Performance

Compression Encapsulation


  • Compression: Kilian T100, T200, S250 ZS-M
  • Encapsulation: Bosch GKF 702, Bosch Checkweigher KKE 2500


Product Performance

Film-Coating and Sugarcoating


  • Filmcoating: Bohle BFC 50 (10-55 Liter), Driam Driacoater (3-6 Liter)
  • Sugarcoating: Brucks Vessels (5-60kg)
  • Pelletcoating: Glatt GPCG-3 Wurster (1-3kg), Midi-Glatt (0.2-0.8kg), Aeromatik MP 3/4

“Our expertise in business development is based on our knowledge of economic manufacturing processes and requirements. We keep the ultimate objective in mind as we prepare the formulation and deliver formula which can be manufactured simply and cost-effectively on a commercial scale. Our unique and impressive staff is comprised of over 40 formulation scientists who use their many years of experience to contribute to the success of the best formulations so that a wide range of solid dosage forms can be offered.”

Dr. Eike Cordts
Director, Business Unit - Development


Quality by Product Transfer

Product Transfer involves transferring to the CDMO the manufacturing and packaging processes as well as the analytical methods – whether for established products already on the market or newly approved drugs. It is crucial that the process of transferring products from a pharmaceutical sponsor to the CDMO is carefully planned and well executed. Product transfer is far more than a hand-off. Rather, it is a two-way transfer of knowledge between contract giver and receiver. Product transfer is a dialogue to fully evaluate risk and optimize processes so that both the final drug product and the contract experience meet the client’s expectations.

Rottendorf Pharma follows precise procedures and takes ownership of processes to ensure a successful Product Transfer. Throughout the transfer phase, our approach to Product Transfer is an exchange rather than a hand-off which means continuous engagement with our clients.

Product Transfer
and Quality

  • A designated project leader for the customer throughout the transfer phase
  • Management of all external/internal activities throughout the transfer phase
  • Design of efficient and robust manufacturing processes
  • Detailed risk evaluation
  • Management of the timeline and budget control
  • Responsibility for the customer's product until validation is successfully finalized

The Transfer Phase

Sets the Stage for Manufacturing

Transfer Grafik


Our Competence is Your Advantage

With the Product Technology department, Rottendorf has created a knowledge hub for all product-related matters during the commercial phase of the product life-cycle. The department comprises Technical Product Support, Bulk Manufacturing Process Excellence, Packaging Process Excellence, and Packaging Process Design.

Commercial Phase of the Product Life Cycle

Rottendorf’s Technical Product Support (TPS), a part of the TPO Center, is the first point of contact for clients in case technical anomalies are detected during the commercial production. In such cases the TPS project managers take ownership and solve the issue jointly with our client and the specialist departments involved. The solving of those issues and the resulting corrective and preventive actions follow precise standardized processes.

Technical Product Support and Quality

To ensure quality, Rottendorf provides:

  • One designated project leader for all technical product-related issues
  • Efficient resolution and ownership of product-related issues
  • Change Management

For commercial bulk manufacturing Rottendorf has established a dedicated team for the continuous optimization of manufacturing processes. Maintaining robust and stable manufacturing processes is essential for keeping our promise to our clients to always deliver on time.

For commercial bulk packaging Rottendorf has established a dedicated team for the continuous optimization of the packaging processes. Maintaining robust and stable packaging processes is essential for keeping our promise to our clients to always deliver on time.

Want to know more?

Please feel free to contact us. We are looking forward to receiving your inquiry. Give us a call or complete the contact form below.