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Risk Mitigation

Excipients play a significant role in the functionality and processability of a formulation. Having an excipient supply shortage could have a significant impact on your business and customers, so why not be better prepared for ensured drug supply to patients. Find out more and see how DFE Pharma can help you in a seamless transfer.

Key excipient supply

  1. Be prepared for a key excipient supply shortage.
  2. Excipients constitute the majority of most dosages form - your success and risk.
  3. Alternate excipient qualification will secure your continuous drug product supply.
  4. Excipient complexity can impact your finished product quality?
  5. DFE Pharma can further risk mitigate by being dual sourced.

Technical Support for alternate sourcing

Excipient risk assessment:

  • Supplier knowledge mitigates risk from unknowns DFE Pharmas’ unique offering
  • Guaranteed high quality control over CMA's, limiting the impact on your product quality
  • Ensured product quality by Batch-to batch consistency in line with QbD
  • Supported with data, samples, and tailored technical expertise
  • Advice targeting your specific application needs

Documentation support for your regulatory approval

DFE Pharma will be your partner offering:

  1. Data beyond the COA
  2. Assistance in determination of equivalence in specific application
  3. A ready to use Excipient Information Package (EIP)
  4. Online ask an expert
  5. 24/7 documentation access
  6. A seamless transfer


Get in touch with our experts to learn how you can mitigate your risk today!