Research & Development

Research and development at Douglas Pharmaceuticals is driven by the specific needs of our domestic and international customers. Our discovery programme is focused primarily on preparing brand-name equivalent drugs and the development of NCEs (New Chemical Entities).

The Douglas Pharmaceuticals New Product Development Group occupies a state-of-the-art laboratory complex. This facility includes three pilot scale manufacturing plants (two fully dedicated to the manufacture of high potency products); two instrument rooms (one with controlled lighting for the analysis of light-sensitive compounds); and an office suite for CMC (Chemistry, Manufacturing and Controls) documentation writing and data checking.

Programme capabilities:

  • We have expertise in the development and manufacture of specialised high potency tablets, soft-gelatin capsules and microencapsulated products.
  • We have developed and produced alternative-brand generics for global markets, fully supported by patient programmes and promotional material.
  • Our team provides CMC services to both generic and NCE clients in compliance with EMA (European Medicines Agency), US FDA (United States Food and Drug Administration) and ICH (International Committee on Harmonisation) guidelines.
  • Many of the generic products we develop are poorly soluble and can present considerable challenges to the achievement of BE (Bioequivalence). Overcoming solubility challenges is a strength of ours.
  • We can assist with formulation and CMC needs for IND filings.