Capabilities

Commercial Manufacture

Millions of patch and film units produced annually

As an FDA registered manufacturer of bulk intermediate drug product for specialty thin film and transdermal patch drug delivery systems, ARx takes a partnership approach with customers from concept to commercialization. The ultimate goal of any ARx product, whether branded or generic, is to provide long-term, stable commercial supply for our customers and enhanced well-being for patients.

Commercial production occurs in GMP suites with larger-scale vessels that are representative of the equipment and processes used in registration. In addition, our development and formulation capabilities are matched to produce stable, well-characterized, single- and multi-layer custom drug delivery systems developed in the design control process.

We offer multiple GMP manufacturing lines that incorporate active pharmaceutical ingredients into dissolvable films and adhesive coatings under 21 CFR Part 211. Production capacity is also continually monitored in consideration of market fluctuations to guarantee reliable supply.

ARx Commercial Support

  • cGMP Manufacturing Suites: FDA registered 21 CFR 211 lab and GMP production suites with expansion capability.
  • Product Launch and Reliable Commercial Supply: Extensive capacity planning and support assure successful product launch and reliable supply.
  • Final Product Release and Certification: Supported by Certificate of Conformance and Certificate of Analysis for bulk roll and finished product.
  • Annual Product Review: Annual review to verify process, product performance, and quality.
  • Life Cycle Management & Next Generation Technologies: Continuously expanding dosage form capabilities to provide brand extension opportunities through specialty delivery applications.

Drug Product Development