Development Services


“Lyne’s mission is to offer drug development services and manufacturing solutions to choice companies that are focusing on creating win/win business partnerships.”

Lyne has over 35 years of development and manufacturing experience which has contributed to its successful record of building business partnerships that yield maximum rewards for both partners.  In recent years, Lyne has expanded its development/R&D staff and opened a new state-of-the-art facility in 2016 to house the R&D group.  Since establishing a separate, single department focused primarily on generic pharmaceuticals, Lyne has supported more than 20 ANDA submissions.

Our Service Offerings to a Business Partnership:

  • Pre-Formulation and formulation development
  • Process development
  • Process scale-up
  • Analytical testing
  • Methods development/validation
  • Stability studies
  • Regulatory support
  • Pilot batches
  • Engineering batches
  • Pilot batches
    • 1 or 3 demonstration batches (1/10th of commercial batch size)
  • Engineering batches
    • Scale-up to commercial size for evaluation prior to validation

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