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Closeup of manufacturing facility

Rochester, Michigan

Endo Contract Manufacturing

Sterile Injectables

Our manufacturing facility in Rochester, Michigan has served the CMO industry for over 40 years. With an expertise in sterile injectables, plus a 100-year history of vaccine innovation and quality, Endo has earned a reputation as a trusted contract manufacturing partner.

Our Experience & Expertise

  • cGMP sterile manufacturing facility
  • CBER- and CDER-inspected
  • Fill-finish manufacturing network
  • 50+ FDA-approved presentations
  • Several tech transfers each year
  • Stable workforce of 450 skilled employees
  • Primary markets served include U.S. and Canada
Rochcester, MI manufacturing facility

Product and Processing Capabilities

Biologic and small molecule

4 product-filling lines (3-100 cc)

  • Liquid and lyophilized
  • Freeze dryers: 70-450 sq. ft.
  • 2 isolator lines, including one BSL-2 isolator line
  • 1 pre-filled syringe: small-batch scale

7 visual inspection lines

  • Equipment capabilities include manual, semi-automated, and automated inspection
  • Support difficult-to-inspect products, including lyophilized and suspension products

7 packaging lines, including manual and automated

Expansive GMP storage

  • USP room temperature
  • USP cold temperature (2°-8°C)
  • Sub-zero storage capability (-20°C for semi-finished and finished goods)
  • API and drug substance storage capability ranges from -20°C to -80°C

Quality Control and Analytical Testing Capabilities

On-site quality operations

Incoming, in-process, release, and stability testing

Coming Soon

New sterile manufacturing facility in Indore, India launching in 2024

Learn more about our contract manufacturing.

To learn more about our fermentation contract manufacturing, get in touch with Pearse Kelly, 484-216-2812,