Fagron announces the acquisition of UCP in North America and FDA inspection update

25 Sep 2025 07:00 CEST

Issuer

FAGRON S.A.

Regulated information - inside information
Nazareth (Belgium)/Rotterdam (The Netherlands), 25 September 2025 – 7:00 AM CET

Fagron announces the acquisition of UCP in North America and FDA inspection update

Fagron, the leading global player in pharmaceutical compounding, is pleased to announce a strategic acquisition that will significantly reinforce its presence in North America. The company has signed the acquisition of University Compounding Pharmacy (UCP), a 503A pharmaceutical compounder specializing in the health and wellness segment in California, whilst adhering to a disciplined acquisition strategy.

The company has also been inspected by the FDA at its Wichita and Las Vegas facilities, with none of the observations from the 2024 inspection in Wichita being now repeated, which validates our remediation has addressed the Agency’s prior concerns.

UCP

UCP, based in San Diego, the U.S., is a 503A pharmaceutical compounder specializing in the health and wellness segment, with strong positions in hormones and urology and a solid compliance record, making it highly complementary to Anazao and enabling a differential coast-to-coast offering. This underpins Fagron’s strategy to build a nationwide compounding platform in the U.S., spanning both 503A (patient-specific) and 503B (outsourcing) services.

The acquisition deepens Fagron’s presence in North America’s prevention and lifestyle segment and strengthens our position in California, one of the largest and most tightly regulated healthcare markets in the U.S., where licences are difficult to obtain.

The enterprise value of this acquisition is c.$41.5 million. It will be fully financed through Fagron’s own resources and remains subject to customary clearance. This business generates around twenty five million dollars in annual revenue and an EBITDA margin below Fagron’s existing group margin. We expect to realise synergies over the next 18–24 months as the business is integrated into Fagron’s operations.

Quality Update

The Food and Drug Administration (FDA) has conducted an inspection at Fagron Sterile Services (“FSS”) in Wichita, Kansas to verify the corrective and preventive actions taken following the routine inspection in June 2024 and the Warning Letter issued in December 2024. In March 2025, the Agency acknowledged our CAPA submission and stated it adequately addressed their concerns, pending an on-site verification. During the 2025 visit none of the observations from the 2024 inspection were repeated, which validates our remediation has addressed the Agency’s prior concerns.

Separately, following this new routine inspection, the FDA issued a Form 483 with six observations. In addition, the FDA also conducted a routine inspection of the 503B Anazao Health facility in Las Vegas with four observations.

Fagron remains committed to working collaboratively with the FDA to address its inspectional observations and is already implementing new corrective actions to further improve its protocols. Our top priority is providing safe and effective sterile drug products to our customers and their patients and we remain confident in our robust systems and the quality and safety of the products we produce.

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Further information
Ignacio Artola
Global Investor Relations Leader
Tel. +34 670385795
ignacio.artola@fagron.com

About Fagron

Fagron is the leading global company active in pharmaceutical compounding, focusing on delivering personalized medicine to hospitals, pharmacies, clinics, and patients in more than 35 countries around the world.

The Belgian company Fagron NV is based on Venecoweg 20A in Nazareth and is listed on Euronext Brussels and Euronext Amsterdam under the ticker symbol ‘FAGR’. Fagron’s operational activities are managed through the Dutch company Fagron BV. Fagron BV’s head office is located in Rotterdam.

Important information regarding forward-looking statements
Certain statements in this press release may be deemed to be forward-looking. Such forward-looking statements are based on current expectations and are influenced by various risks and uncertainties. Consequently, Fagron cannot provide any guarantee that such forward-looking statements will, in fact, materialize and cannot accept any obligation to update or revise any forward-looking statement as a result of new information, future events or for any other reason.

In the event of differences between the English translation and the Dutch original of this press release, the latter prevails.

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