Built for long-term reliability
Established heritage
More than 40 years of continuous operation and regulatory compliance.
FDA- and DEA-inspected site
Proven record of quality, safety and control.
Location with purpose
Based in Pisgah Forest, NC, supporting U.S.-based pharmaceutical manufacturing.
Commitment to quality
cGMP discipline and traceability built into every process.
Global perspective
Backed by Ipca Laboratories’ worldwide expertise and network.
Integrated capabilities. Delivered with care.
Our FDA- and DEA-registered site is engineered for control, traceability and efficiency, supporting every stage of API development and manufacturing, and laying the groundwork for expanded formulation capabilities:
- cGMP API manufacturing suites.
- R&D and analytical laboratories.
- Dedicated quality and administrative spaces.
- Temperature-controlled warehousing and validated utilities.
A new formulation facility
Launching in 2026, our new formulation facility will bring sterile injectable and oral liquid manufacturing online, advancing us toward a fully integrated CDMO and giving you confidence from development to supply.
For quality without compromise
At Pisgah Labs, quality is an integral part of our culture — it guides every decision and defines how we work.
Our teams take a disciplined, hands-on approach, combining scientific precision with regulatory integrity to ensure consistent control from development through manufacturing.
We share a single goal: to deliver work that meets the highest standards of compliance, accuracy and care.
Our capabilities span every stage of API development and manufacturing, built on four decades of scientific precision and regulatory discipline.
Connect with our team
Explore how we can help you reach your next milestone with confidence.