Clinical trial manufacturing

Precise single- and double-sided tablet imprinting using R. W. Hartnett Delta-Printer and Agate S printer technology to apply logos, batch numbers and text on various tablet shapes and coatings.

Tablet compression on Euro B/D rotary presses (Korsch, Fette, etc.) for single, double-layer tablets, plus capsule filling on Bosch GKF series machines with 100 % weight control, from development to commercial scale.

Comprehensive analytical services from method development and transfer to routine testing of raw materials, excipients and finished products in a GMP/FDA-certified laboratory, leveraging over 180 experts and advanced techniques (HPLC, GC, dissolution, Karl Fischer, ICP, TLC, etc.) to ensure regulatory comp...

Robust mixing of APIs and excipients using high-shear blenders (Diosna P600, VAC 10+60) and free-fall blenders (Bohle PM-series) in both development (0.5–150 kg) and commercial manufacturing (2–750 kg) to achieve uniform blend homogeneity.

High-speed blister packaging on 13 fully automated lines (Uhlmann BEC 300/500, IMA Giant), handling PVC/PVDC, Alu-Alu, ACLAR® and PP foils with serialization and aggregation capabilities in a GMP certified cleanroom environment.

Automated bottle filling on three Uhlmann IBC 120/150 lines and one powder-filling line (Optima), including counting, induction sealing, torque-controlled capping and 100 % in-line inspection, all under GMP compliance.

Tablet film coating on seven dedicated coaters (All scales available: Bohle BFC 5, BFC50, BFC400, BFC600) for aqueous and organic solvent processes, with automated parameter control and full process documentation in a GMP-certified environment.

Formulation and process development for oral solid dosage forms from lab and pilot scale to commercial production (0.5–150 kg) in a GMP/FDA-approved pilot plant; includes dry-, fluid-bed- and wet granulation, hot-melt extrusion/melt granulation, tabletting, filmcoating, mini-tablet and pellet technologies;...

Precision filling of dry granulates into bottles using gravimetric and volumetric dosing, integrated bottle cleaning, camera inspection, induction sealing and torque-controlled capping, ensuring uniform fill weights under cleanroom and GMP conditions.

End-to-end granulation services including fluid-bed (GPCG series), high-shear (Diosna series) and dry roller compaction (Gerteis Mini- and Macropactor) for batch sizes from 1 to approx. 750 kg, all conforming to GMP requirements.

Handling of high-potency APIs with an OEL values from 1µg/m³ onwards is dpendent on drug load and manufcaturing process. Rottendorf will invest into high potency for handling compounds with an OEL value of 0.1/m³.

Continuous melt extrusion using co-rotating twin-screw extruders (Leistritz ZSE 18HP) enabling enhanced solubility and controlled-release pellet formation.

Faster time to market: Integrated early-development offering and accelerated commercial pathway for biotech companies.