Company Profile | February 1, 2012

JHP Pharmaceuticals - Contract Manufacturing Services

Source: JHP Pharmaceuticals


 

JHP Pharmaceuticals' Rochester, Michigan facility (www.jhppharma.com) has been providing contract manufacturing services for sterile injectables for over 25 years. JHP's cGMP-compliant manufacturer offers customers two distinct advantages:

  • An established infrastructure of resources and capabilities combined with a broad and deep experience base
  • Flexibility to meet customer needs in a timely fashion

Continuing facility and business investments focus on a sound and flexible infrastructure: not too big, not too small which provides the attention both customers and projects require. From a new clinical filling line that maximizes yield to disciplined cross-functional project teams using a rigorous tech transfer process, JHP offers both the right scale and right experience to meet a broad range of contract manufacturing needs.

JHP is licensed by FDA, EMA and other international regulatory agencies and manufactures products for sale in 85 countries:

Sterile Manufacturing Services
JHP offers a wide range of sterile processing capabilities including:

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

Meeting Needs Across a Product's Life Cycle
JHP has the scale and experience to meet a product's life cycle needs:

  • Clinical trial material manufacture
  • Product Launch
  • Commercialization

Sterile Product Types
JHP fills a variety of product types including:

  • Antibiotics
  • Biologic Filling
    • Peptides
    • Recombinant Proteins
    • Vaccines
  • Controlled Substances
    • Scheduled Drugs (CIII and CIV)
    • List I Substances
  • Small Molecule

Technical Support Services
When choosing JHP, customers also have access to a comprehensive suite of support services including:

  • Analytical and Microbiological Services
  • Package Engineering
  • Project Management
  • Regulatory Affairs

Technology Transfer
An efficient and disciplined tech transfer process is the starting point for successful contract manufacturing partnership. JHP's established project management teams ensure a customer-centric focus and ongoing communication during this important process.

Sterile Manufacturing Facility, Rochester Michigan
Located on over 80 acres in Rochester Michigan, the facility includes 171,000 sq. ft. production building with aseptic filling and packaging lines including 44,000 sq. ft. warehouse. JHP's manufacturing facility includes several high-speed filling lines, a clinical line filling, an ophthalmic filling line, terminal sterilization and lyophilization services.

  • Two independent filling suites:
    • Separate HVAC systems; dedicated ingress and egress, and gowning
  • Cogeneration system on site to provide constant power supply
  • Separate laboratory facilities for chemistry, sterility, testing, analytical methods and development

With broad experience handling a variety of complex liquid and lyophilized products and extensive expertise in biologics filling, JHP Pharmaceuticals offers both the right scale and right experience to meet clinical, launch and commercial supply needs.