Reliable Drug Substance, Drug Product Development & Manufacturing Services

Services

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.

Drug Substance Services

  • Pre-Clinical
  • Phase I
  • Phase I
  • Phase II
  • Phase III
  • Commercial
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
  • pGTI evaluation
  • Analytical method development and validation
  • Manufacture of clinical supplies
  • NDA filing support
  • Tech transfer and large-scale commercial manufacture

Drug Product Services

  • Pre-Clinical
  • Phase I
  • Phase I
  • Phase II
  • Phase III
  • Commercial
Non-GMP & GMP Clinical supplies
  • Pre-formulation studies
  • Formulation feasibility studies
  • Large volume OSD (Tablets, Capsules) manufacture
  • Fully-serialized (Track & Trace)
  • Tech transfer & scale up

Niche Solutions

HP API Manufacture

Extensive experience in the manufacture of Highly-Potent APIs & Intermediates at pilot & commercial scale.

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Resolution and separation capabilities

Conventional column chromatography capabilities, both at pilot and commercial scale.

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Backward integration of starting materials

Backward integration of starting materials to mitigate supply and quality risk for customers

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