API Manufacturing
Sterling Pharma Solutions - Cary
1001 Sheldon Dr #101, Cary, NC 27513
- cGMP, ISO/IEC 9001:2015
- Millilitres up to 200 litres batch size
About Sterling Pharma Solutions - Cary
Sterling Pharma Solutions operates a cGMP active pharmaceutical ingredient (API) manufacturing facility in Cary, North Carolina. The site is part of Sterling Pharma Solutions Limited, a UK-registered company (registration 05712796) with a 50-plus-year heritage in small-molecule development and manufacturing. The global organisation is headquartered in Cramlington, United Kingdom, and the Cary location was established to serve U.S. clients with early-phase API development and clinical supply. The Cary facility specialises in high-value, low-volume cGMP production of APIs in batch sizes ranging from millilitres up to 200 litres, including carbon-14 radiolabelling. It supports projects from preclinical development through Phase II clinical trials, offering full-service API development and manufacturing. The site is DEA-approved for Schedule I-V controlled substances and operates under a quality management system certified to ISO 9001:2015 and ISO 27001. Globally, Sterling employs more than 1,350 people across six sites in the UK, Ireland, and the United States. Sterling serves pharmaceutical and biotechnology companies developing small-molecule therapeutics, including high-potency APIs, hazardous chemistries, controlled substances, peptides, and antibody-drug conjugates (ADCs). Customers range from early-stage biotechs requiring route scouting and preclinical supply to larger firms needing clinical trial material and commercial-scale manufacturing. The Cary site specifically targets U.S.-based sponsors seeking domestic cGMP capacity for early-phase programmes. The company positions itself as a Partnership Development and Manufacturing Organisation (PDMO®), emphasising a collaborative, transparent service model over a traditional transactional CDMO relationship. Its stated differentiators include deep expertise in complex and hazardous chemistries, a global integrated network that allows flexible project routing, and a Technology and Innovation Programme that explores biocatalysis, continuous processing, and other emerging technologies to improve client outcomes.
Manufacturing capabilities
Industries served
- Pharmaceutical
- Biotechnology
- Small molecule therapeutics
- Antibody-drug conjugates
- Peptide therapeutics
Company details
- Location
- Cary, North Carolina
- Production volume
- Millilitres up to 200 litres batch size
- Certifications
- cGMP, ISO/IEC 9001:2015, ISO/IEC 27001, DEA Schedule I-V registration
Frequently asked questions
Where is Sterling Pharma Solutions - Cary located?
Sterling Pharma Solutions - Cary is located at 1001 Sheldon Dr #101, Cary, NC 27513.
What does Sterling Pharma Solutions - Cary do?
Sterling Pharma Solutions - Cary is listed under API Manufacturing, and its listed capabilities and products include cGMP API manufacturing, Early-phase clinical supply, Controlled substances handling (Schedule I-V), 14C radiolabelling, API process development and Route scouting and design.
What industries does Sterling Pharma Solutions - Cary serve?
Sterling Pharma Solutions - Cary lists Pharmaceutical, Biotechnology, Small molecule therapeutics, Antibody-drug conjugates and Peptide therapeutics among the industries it serves.
What certifications does Sterling Pharma Solutions - Cary have?
Certifications on file for Sterling Pharma Solutions - Cary: cGMP, ISO/IEC 9001:2015, ISO/IEC 27001 and DEA Schedule I-V registration.
How do I request a quote from Sterling Pharma Solutions - Cary?
Use the Request a quote button on this page to send Sterling Pharma Solutions - Cary your requirements through FirmsLedger, or visit sterlingpharmasolutions.com.
What companies are similar to Sterling Pharma Solutions - Cary?
Other API Manufacturing companies in North Carolina listed on FirmsLedger include Cambrex High Point, Novo Nordisk - Clayton and MedPharm USA CTM & Commercial Production.