Chemical Development services
Syngene offers complete value-chain process research and development services across novel chemical entities, APIs, and advanced intermediates – route-scouting to commercial manufacturing.
Formulation Development services: Stable and compliant drug formulations across oral solids and parenterals
Syngene offers Formulation Development services for oral solids, liquids, and injectable forms, including integrated services focusing on quality, speed, and cost-efficiency.
Sterile Fill-Finish facility: Your integrated partner for customized clinical supplies
Syngene’s Sterile Fill-Finish facility is custom-built to meet market demand for clinical supply of sterile drug products having short development timelines.
Analytical Development services – IND Filing to Commercial
Syngene has one of the largest Analytical facilities in Asia. The facility supports small molecules and biologics programs from early development to CMC filing and commercialization.
Nitrosamine Impurity Testing Services
Syngene’s Center of Excellence for Nitrosamine impurity testing supports formulation requirements for small molecule APIs, key sourcing materials, and intermediates.
ICH Stability services
One of the largest Stability facilities in Asia, Syngene supports both small molecules and biologics from early development to CMCÂ
Clinical Development services
Syngene supports early-phase to late-phase clinical trials required for drug development programs across a wide range of therapeutic areas.
Comprehensive solutions for Clinical Development of generic drugs
Synene has developed more than 100 assays for conducting BA/BE studies across small molecules and biologics.
Commercial Manufacturing services
Syngene supports manufacturing of regulatory starting materials, APIs, HPAPI, NCEs and novel advanced intermediates