Drug Substance

From Lab to Commercial

Servier’s comprehensive range of manufacturing and development services includes drug substance manufacturing from lab to pilot batch through scale-up to commercial volumes.

We bring 60 years of experience in process development, intermediates, APIs and high-potency APIs (HPAPIs) to your projects. Our full cGMP / FDA-approved chemistry network includes R&D, production and supply chain expertise with full regulatory support. We are able to take your product from lab scale to commercial production all within our dedicated facilities.

Drug Substance Capabilities

  • Custom manufacturing and synthesis
  • HPAPIs
  • Analytical & chemical development
  • Identification of pharmaceutical impurities
  • Clinical batches
  • Crystallization
  • Polymorphism, stability and process development studies
  • Process safety assessment
  • List of commercial APIs and intermediates available on request

Integrated Systems & Equipment

  • Kilo lab facility
  • Scale-up from kilograms to several metric tons
  • Pilot and manufacturing units include 8L to 10,000L reactors
  • Wide range of analytical equipment
  • Isolation and drying devices
  • Solid transformation capacities

Innovative Technologies

  • InnoPrePTM  industrial preparative chromatography
  • Catalytic hydrogenation — up to 300º C / 210 bar
  • Flow chemistry process development — up to 5kg/day

We are able to take your product from lab scale to commercial production all within our dedicated facilities.

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Drug Substance