From Pre-clinical to Commercial, Laurus Synthesis offers the dependability our customers need with regard to solving complex chemistry and analytical challenges, on-time delivery and consistent global quality standards. Our development and manufacturing teams maintain a tight focus on performance at scale, continuous process improvement, securing and de-risking supply chains to provide an efficient, compliant, cost-effective and long-term commercial drug substance and drug product solutions.
|Non-GMP & GMP Synthesis: Regulatory Statring Materials, Intermediates, API
Quick process development from Med Chem synthetic route
Non-GMP/GMP scale up to analytical method development
Route scouting and finalization
Full Process Optimization using QbD approach
Analytical method development and validation
Manufacture of clinical supplies
NDA filing support
Tech transfer and large-scale commercial manufacture
|Non-GMP & GMP Clinical supplies
Formulation feasibility studies
Large volume OSD (Tablets, Capsules) manufacture
Fully-serialized (Track & Trace)
Tech transfer & scale up
|Analytical methods development, transfer and validations
Extensive experience in the manufacture of Highly-Potent APIs & Intermediates at pilot & commercial scale.
Conventional column chromatography capabilities, both at pilot and commercial scale.