CDMO services for HPAPIs

CDMO services for HPAPIs
Product Description

Novasep offers a full range of CDMO services for HPAPIs from process development to cGMP production.
Our Le Mans site is equipped to handle compounds with an OEL below 30 ng/m³/8hrs and a maximum batch size of 10 kgs.

Process development

  • Transfer and continuous improvement of established processes
  • Development & scale-up of new processes
  • Development, optimization and validation of analytical methods
  • Safety assessments

Kilolabs & Large-scale production

  • cGMP production for clinical trials
  • Process validation
  • Commercial supply

Quality control
  • Method development / transfer / validation
  • IPC
  • Release testing
  • ICH Stability studies
  • Regulatory support

Novasep

  • FR
  • 2015
    On CPHI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Company types
Manufacturer/Innovator
Primary activities
API Producer
Chemical Development
Custom Manufacturing/Custom Synthesis

Novasep

  • FR
  • 2015
    On CPHI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Company types
Manufacturer/Innovator
Primary activities
API Producer
Chemical Development
Custom Manufacturing/Custom Synthesis

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