Compare CDMOs with ICH stability testing capabilities. Filter by chamber capacity, ICH condition support, and regulatory filing experience.
454 companies listed
Stability testing determines how a drug product changes over time under defined storage conditions (temperature, humidity, light). ICH guidelines (Q1A-Q1E) specify the conditions, timepoints, and statistical analysis methods used globally. Stability data is required for regulatory submissions to establish shelf life and storage conditions.
CDMOs offering stability services need: validated stability chambers (temperature and humidity controlled), GMP-compliant analytical testing capabilities, sample management systems for multi-year programs, and regulatory expertise to design study protocols that support global filing strategies.
United States
UPM Pharmaceuticals is a U.S.-based CDMO specializing in late-stage commercial manufacturing of semi-solid and oral solid dose products. Operating from a 475,000 sq ft cGMP FDA-registered facility in Bristol, Tennessee, UPM is a family-owned company with 30+ years of experience. They handle DEA-controlled substances and provide services from technology transfer and scale-up through commercial manufacturing. Capabilities include formulation development, analytical development, coated tablet manufacturing, pharmaceutical serialization, aggregation, and full packaging and warehousing.
Germany
Vetter Pharma is a leading global Contract Development and Manufacturing Organization specializing in aseptic fill-and-finish services for injectable drug products. Headquartered in Ravensburg, Germany, Vetter operates as an independent, family-owned business with over 75 years of experience.
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