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APIs. Growing Pressure from Global Competitors.

Facing growing pressure from global competition, API manufacturers need to resolve complex chemistry or biotechnological challenges to offer advanced drugs and apply new technology for cost-effective and regulatory compliant processes.

Gain world-class API manufacturer recognition through differentiation


In order to be recognized as a reliable, innovative and competitive supplier of APIs, manufacturers need to:

  • produce drugs at state-of-the-art cGMP manufacturing facilities, approved by regulatory authorities like FDA
  • guarantee an uncompromising product quality
  • ensure cost-effective production operations
  • provide flexible solutions from process development, through pilot scale-up to full scale production
  • improve customer delivery performance

 

XFP-MES: Robust, pre-validated solutions designed for API manufacturers

Allowing a large number of products and/or extensive volume of products to be manufactured, the XFP-MES suite provides advanced features enabling API manufacturers to:

  • Accelerate time-to-market and improve productivity thanks to scalable and streamlined processes modelled according to XFP advanced OPM technology
  • Guarantee cGMP compliance and build quality into the production process with directed process operations and automated pharmaceutical controls
  • Reduce waste and costs with lower inventory levels, error removal and real time process visibility
  • Provide the required documentation for regulatory purpose, customers’ audits and drug registration: audit trail, electronic batch record and graphical batch genealogy

 

Real time process management with end-to-end traceability


A real-time information system for cGMP manufacturing facilities, XFP-MES manages and secures any type of process while guaranteeing a full traceability of the operations performed.

Bridging the gap between lab and production


Seamlessly integrated with ERP, LIMS, SCADA, automation and other systems, XFP-MES orchestrates the overall production processes and connects lab and production activities. Easy to use and fast to deploy, the XFP-MES Suite provides advanced features that enable API manufacturers to accelerate their process development and their operation executions. Their time-to-market is therefore dramatically reduced.

A partner for continuous improvement strategies


Modular, flexible and scalable, the XFP-MES Suite provides API manufacturers with continuous improvement capabilities. Their responsiveness to market is enhanced while processes are kept robust, safe and compliant.