Facilities built for quality and engineered for consistency
Situated across more than 120 acres in Pisgah Forest, our site comprises three cGMP manufacturing suites, R&D and analytical laboratories, quality and administrative offices, as well as secure warehouse and utility areas.
Each space is purpose-designed to maintain control, efficiency and traceability throughout the API lifecycle, from laboratory development to commercial production.
Administration and quality labs
- QC laboratories with advanced instrumentation, including HPLC, GC, FTIR, UV-Vis, TOC and ICH stability chambers for method development and validation.
- QA systems manage SOP lifecycle, deviations, risk assessments and change control under 21 CFR Part 210/211.
- Proven history of successful FDA and DEA inspections.
- Administrative offices ensure smooth coordination between operations, quality and client communication.
R&D and manufacturing
- R&D labs for process development, non-GMP synthesis and scale-up.
- Three cGMP manufacturing suites with reactor capacities from 80 L to 8,000 L (glass-lined and Hastelloy).
- Manufacturing suites classified as Class I, Division 2 hazardous environments for safety and containment.
- Key operations: reactions, distillation, centrifuging, filtration, drying, milling and sifting.
- Expertise in complex chemistry and controlled substances (Schedules I–V).
Warehouse and utilities
- Controlled substances storage vault.
- Robust utilities: hot oil boilers, chillers, vacuum pumps, HEPA-filtered HVAC systems.
- Temperature-controlled areas, with a temperature-controlled warehouse under construction.
- USP/EP purified water system delivers 6GPM at 18.2 Mohms.
- Mechanical rooms and utility zones are fully segregated from production for safety and compliance.
Expanding our capabilities
Your molecule is our priority. That’s why we’re expanding.
Construction is underway on new facilities that will extend our expertise beyond API manufacturing to include sterile injectable and liquid oral dosage form production.
An integrated global network
Pisgah is part of Ipca Laboratories’ global network and works in close step with our sister CDMO, Onyx Scientific. Together, we support your API from first studies through scale-up and sustained supply.
Ipca Laboratories
Ipca Laboratories is Pisgah’s parent company and a fully integrated pharmaceutical group. For more than 60 years, Ipca has been a crucial healthcare partner in over 120 countries. It brings broad API and finished-dose experience, global manufacturing scale and long-standing regulatory strength to support your program over the long term.
Visit Ipca.comOnyx Scientific
Based in Sunderland, U.K., Onyx Scientific specializes in small molecule API development and supply, for early phase through to commercial manufacture. With strong technical expertise in process R&D, solid-form and analytical development plus compound support services, Onyx delivers a bespoke and flexible service that includes the manufacture of non-GMP and GMP API for phase I and beyond.
Visit Onyxipca.comOur purpose-built environments and experienced teams enable the quality and consistency behind every service we provide.
Partner with a CDMO rooted in quality
Connect with our experts today and see how disciplined science supports your next milestone.