Product/Service

Clinical Trials / Small Batches

Source: JHP Pharmaceuticals

Regulatory

JHP has the experience and capabilities to provide scale-driven efficiencies preferred for clinical supply.

JHP Pharmaceuticals’ Rochester, Michigan facility has been providing contract manufacturing services for sterile injectable products for over 25 years. With this strong foundation, JHP has extensive expertise providing clinical trial materials, launching products and producing commercial supply.

Sterile Product Manufacturing Services:

  • Aseptic Fill/Finish Manufacturing
  • Lyophilization/Freeze-Drying
  • Terminal Sterilization

 

In 2011, JHP installed a new Bosch clinical line filler to support customer needs for scale-driven efficiencies required for clinical trial materials and small batch sizes.

Clinical Line Filler

  • Higher yield, minimal line loss
  • Broad range of products
  • Reduced cycle time

 

JHP’s sterile manufacturing facility sits on over 80 acres and includes a 171,000 sq. ft. production building and 44,000 sq. ft. warehouse. The site has separate facilities for chemistry, sterility testing, and microbiological testing, providing customers with a variety of support services.

JHP provides the Right Scale and Right Experience to meet clinical trial material or small batch contract manufacturing needs. In choosing JHP, customers also have access to a comprehensive suite of support services including: Regulatory, Analytical Methods Development, Package Engineering, Stability Testing and Validation.

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Fact Sheet: Clinical Trials / Small Batches