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Clinical Supplies Manufacturing

Drug products, including gels, creams, ointments, solutions and suspensions that are intended for clinical use are manufactured and filled in our dedicated production suites under GMP (Good Manufacturing Practices). Batch sizes may range from 250 grams to 35 kilograms.

Clinical Supplies Manufacturing

Pharmaceutical Product Manufacturing and Filling for Use in Clinical Trials

The drug product may be filled into:

  • Tubes (laminate or aluminum)
  • Glass or plastic vials or bottles
  • Syringes
  • Pumps
  • Sachets

During our topical drug product manufacturing process, the selected primary packaging material is confirmed to be compatible with the active pharmaceutical ingredient (API) in the drug product in advance of GMP manufacture and filling.

Drug Product Release

Products are released as per quality standards with strict quality assurance oversight. Depending on the product, release testing may include:

  • Assay for API and degradation products
  • ID
  • Appearance
  • pH
  • Viscosity
  • MET (USP<61> and <62>)

Certificates of Analysis are prepared and approved for each batch. GMP stability testing may also include AET (USP<51>), weight loss and package integrity.

Contact Us About Topical Drug Product and Clinical Supplies Manufacturing Services

For questions or inquiries as to how Dow Development Laboratories’ topical drug product manufacturing specialists can be of assistance to you, please contact us at