Enteris specializes in solid oral dose clinical trial manufacturing through Phase 3 and commercial manufacturing. Our new purpose-built, state-of-the-art cGMP manufacturing facility features over 6,000 square feet (560 square meters) of cleanroom space, with approximately 2,500 square feet (230 square meters) dedicated to HPAPI powder handling.
The HPAPI containment area has been engineered to safely handle banding category 3. Depending on the solid oral dosage unit’s physical characteristics, batch sizes can vary from a few hundred dosage units to hundreds of thousands of dosage units.
We have considerable expertise in process development, process scale-up, technology transfer, and process validation with precise quality assurance and control systems that are fully compliant with FDA, EMA, and ICH. Whether your product is a solid oral dose that utilizes our proprietary oral formulation technologies, Peptelligence® or ProPerma®, or another formulation technology, Enteris will ensure optimal manufacturing of your clinical and commercial supplies.
Tablet and Capsule Units
- Tablet and Mini-tablet compression
- Capsule filling
- Direct compression
- Wet granulation
- Dry granulation
- Aqueous pan coating
- Bulk or bottle packaging
- HPAPI containment and processing