Small-Volume Manufacture of Active Pharmaceutical Ingredients (APIs)
Noramco offers a flexible high-containment suite with controls in place to produce compounds of OEL<500 ng/m3 and systems in place to create NSP-grade APIs for parenteral applications. Special adaptations in suite design, equipment design, operations and process safety afford developers a one-stop location to produce on an R&D scale, then advance through clinical stages and finally to commercial production of small-volume APIs.
At Noramco, we offer more than access to state-of-the-art suites. We provide:
– An in-house team of chemists and engineers to help optimize small-scale manufacturing
– Comprehensive analytical, regulatory, physical properties, and stability support
– Integration of quality by design to API development and manufacture
Noramco reduces your time to market with a customer-focused, knowledgeable regulatory affairs team to supply comprehensive documentation, from IND support to commercial filings.