Our CDMO operations are housed within a 32,000-square-foot (2,970 square meters), FDA-inspected and cGMP-compliant facility in northern New Jersey comprised of an unparalleled team of industry-leading scientific subject matter experts with robust institutional experience, highly specialized technical project management, and rapid problem-solving expertise.
Enteris BioPharma provides total integrated CMC service support, including pre-formulation, formulation, analytical research and development, quality assurance, and clinical and commercial manufacturing of solid, oral dosage forms while keeping our partner’s product vision the highest priority. We have a new purpose-built, state-of-the-art facility equipped to handle myriad active pharmaceutical ingredients (APIs), including dedicated processing and containment areas for high potency active pharmaceutical ingredients (HPAPIs).
ABOUT ENTERIS BIOPHARMA
- U.S.-based production and supply chain
- 32,000-square-foot (2,970 square meters), new purpose-built, state-of-the-art, cGMP facility
- 1,700 square feet (160 square meters) of flexible suite space enabling Enteris to adapt to our partner’s development and manufacturing campaign needs 2,500 square feet (230 square meters) dedicated to HPAPI powder handling
- Total integrated CMC service support across pharmaceutical development life cycle
Industry-leading Quality Assurance and Control Systems
- Systems compliant with FDA, EMA and ICH
- Customer focused, providing real time feedback on all quality related issues
- Full project participation:
- Process development → batch record design → GMP manufacture
- Manufacturing oversight through concurrent batch record review
- Vendor auditing and qualification program