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Lifecore

Sterile injectable CDMO with 60 years of regulatory expertise and a fear-no-challenge culture.

Lifecore is a sterile injectable CDMO with 60 years of regulatory experience, offering end-to-end services including formulation and process development, aseptic manufacturing, fill-finish, analytical testing, stability, and assembly and packaging for drugs, biologics, medical devices, and combination products. Headquartered in Midwest, United States.

Modalities

Development & manufacturing

Structured CDMO capabilities from verified public sources.

Development (D)

Manufacturing (M)

Fill-finish formats

Regulatory clearances

Services

About this organization

Overview

Lifecore is a CDMO and sodium hyaluronate producer specializing in clinical and commercial sterile injectable drug products. With 60 years of patient support and a 40+ year global regulatory track record, the company serves as a manufacturing partner for complex molecules and difficult processes.

Core Capabilities

End-to-End CDMO Services:

  • Formulation and process development
  • Aseptic manufacturing
  • Fill-finish operations
  • Analytical testing and stability studies
  • Assembly and packaging
  • Quality and compliance support

Product Support:

  • Drugs
  • Biologics
  • Medical devices
  • Combination products
  • API and excipient manufacturing

Sodium Hyaluronate Products:

  • Research-use formulations
  • Hydrogels
  • GMP and custom modifications
  • Methacrylated sodium hyaluronate

Regulatory & Quality

Anchored by a robust Quality Management System (QMS), Lifecore supports phase-appropriate approaches from pre-clinical to commercial programs. The company is Annex 1 compliant and Midwest-based in the U.S., collaborating with clients globally.

Locations

  • Headquarters

    Midwest · United States

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