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29 Sep 2025
Admin
News Article

Fagron Expands in North America with UCP Acquisition and FDA Update

Fagron, a global leader in pharmaceutical compounding, has announced two major updates that strengthen its US footprint: the acquisition of University Compounding Pharmacy (UCP) in California and progress on FDA inspections at its facilities.

Acquisition of University Compounding Pharmacy

Fagron has signed a deal to acquire University Compounding Pharmacy (UCP), a 503A compounder based in San Diego.

Key points:

Specializes in health and wellness, with strong positions in hormones and urology
Known for a solid compliance record
Complements Anazao Health and supports a coast-to-coast US compounding platform covering both 503A (patient-specific) and 503B (outsourcing) services
Strengthens Fagron’s presence in California, a major healthcare market with strict licensing requirements

The acquisition is valued at ~$41.5 million, fully financed with Fagron’s own resources.

UCP generates about $25 million in annual revenue with an EBITDA margin below Fagron’s group average. Integration is expected to yield synergies within 18–24 months.

FDA Inspection Updates

Fagron Sterile Services (FSS) in Wichita, Kansas, was recently inspected by the US FDA.

Purpose: to verify corrective and preventive actions following the June 2024 inspection and the December 2024 Warning Letter
March 2025: FDA confirmed the CAPA submission adequately addressed concerns, pending on-site review
2025 visit outcome: none of the 2024 observations were repeated, validating Fagron’s remediation

New findings:

FDA issued a Form 483 with six observations at the Wichita site
A separate routine inspection of the 503B Anazao Health facility in Las Vegas resulted in four observations

Commitment to Quality

Fagron emphasized its continued collaboration with the FDA and immediate steps to implement additional corrective actions.

The company reaffirmed its top priority: delivering safe, effective, and high-quality sterile drug products for patients and healthcare providers.

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