Over 100 years of combined experience
Our facility is equipped with 5 manufacturing suites. Our climate-controlled warehouse has the necessary space to accommodate manufacturing operations of commercial pharmaceutical drug products.
Winder Labs has a wide range of both large and small-scale equipment for pharmaceutical trials and formulation development, and larger scale equipment to support large retail demand and contract manufacturing services.
Winder Labs has a fully equipped laboratory space to accommodate analytical method development and validation to perform on-site quality testing for the timely release of products.
Winder Labs offers advanced technologies for analytical development, validation, and formulation.
This approach supports product development of drug products leading to NDA and ANDA submissions. Our analytical services include:
• Formulation development
• Method Validation in accordance with ICH Q2 and USP requirements
• Protocol driven stability studies
• Cleaning residual assays
• Stability indicating assays by HPLC and GC (including forced degradation studies)
• Dissolution testing
• Preservative assays
• Physical testing methods and equipment
• Other wet chemistry capabilities