ACA Pharma and Azurity Pharmaceuticals Announce Approval of Feraheme® and Ferabright™ in Macau

NEW YORK, NY, UNITED STATES, May 21, 2026 /EINPresswire.com/ -- ACA Pharma and Azurity Pharmaceuticals announced that Feraheme^® and Ferabright™ have each received regulatory approval in Macau, marking an important step in expanding access to ferumoxytol-based products across key markets in Asia.

These approvals reflect the continued collaboration between ACA Pharma and Azurity to advance regulatory pathways and improve patient access throughout Greater China. Macau remains an important entry point for innovative therapies and may support broader regional access initiatives.

“We are pleased to reach these important milestones together with Azurity,” said Mike Zhou, CEO of ACA Pharma. “The approvals of both Feraheme and Ferabright in Macau reflect strong coordination between our teams and reinforce our commitment to expanding access to important products across the region.”

“Approval in Macau represents a meaningful step forward for Feraheme and Ferabright, and an important milestone in Azurity’s continued international expansion efforts,” said Ronald Scarboro, CEO of Azurity Pharmaceuticals. “We value our partnership with ACA Pharma and look forward to continuing to work together to expand access to important therapies and support patients across this strategically important region.”

Following the approvals in Macau, ACA Pharma and Azurity are advancing the next phase of regional access efforts, including initial hospital engagement and related institutional review processes to support potential participation in the Guangdong-Hong Kong-Macao Greater Bay Area pilot zone, subject to applicable regulatory, hospital, and governmental requirements.

About ACA Pharma

Founded in 1997, ACA Pharma is a U.S.-headquartered company specializing in fast-track registrations, early access programs, and end-to-end commercialization for innovative medicines and medical devices worldwide. The company is best known for its Macau Fast-Track platform for medicines and Hong Kong Fast-Track pathway for advanced devices, which can enable market entry in as little as 30–90 days in Macau and approximately three months in Hong Kong. These hubs then serve as launchpads to bridge into mainland China via the Greater Bay Area and other national pilot zones, with the real-world evidence generated supporting accelerated national approvals — particularly for products addressing unmet medical need, clinically urgent conditions, or rare diseases. Learn more at www.acapharma.net

About Azurity Pharmaceuticals

Azurity Pharmaceuticals is a privately held global pharmaceutical company dedicated to redefining medicine for the real world. Azurity’s first-in-class enterprise model challenges the status quo by rethinking how therapies are designed, delivered, and accessed. ​With more than 50 medicines across 10 therapeutic areas, Azurity’s mission is fueled by a growing portfolio that reaches millions of people in more than 50 countries. Learn more at www.azurity.com.

About Feraheme

Feraheme^® (ferumoxytol injection) is an intravenous (IV) iron replacement therapy indicated in the United States for the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral iron or have had an unsatisfactory response to oral iron, as well as in adult patients with chronic kidney disease (CKD). Feraheme received marketing approval from the U.S. Food and Drug Administration (FDA) in June 2009. Feraheme^® (ferumoxytol injection) received approval in Macau on April 2, 2026.

For additional information on the U.S.-approved product, including Full Prescribing Information and Boxed Warning, please visit www.feraheme.com. Product label and prescribing information, including product safety information, for product sold outside the U.S. may be different, subject to applicable local laws, regulations, and guidance from applicable regulatory institutions.

About Ferabright

Ferabright™ (ferumoxytol injection) is an iron-based contrast agent indicated in the United States for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms of the brain to visualize lesions with a disrupted blood-brain barrier. Ferabright uses superparamagnetic iron oxide nanoparticles designed to enhance image contrast and delineation of brain tumors compared with non-contrast MRI. Because Ferabright is processed through normal iron metabolism pathways, it offers a non-gadolinium alternative and can be used in patients with renal insufficiency in accordance with its approved label. Ferabright received marketing approval from the U.S. Food and Drug Administration (FDA) in October 2025. Ferabright^® (ferumoxytol injection) received approval in Macau on May 13, 2026.

For additional information on the U.S.-approved product, including Full Prescribing Information and Boxed Warning, please visit www.ferabright.com. Product label and prescribing information, including product safety information, for product sold outside the U.S. may be different, subject to applicable local laws, regulations, and guidance from applicable regulatory institutions.

Media Contacts

ACA Pharma: info@acapharma.net
Azurity Pharmaceuticals: media@azurity.com

Feraheme^® and Ferabright™ are trademarks of Covis Pharma GmbH, a wholly-owned subsidiary of Azurity Pharmaceuticals. This press release may contain forward-looking statements, including statements regarding anticipated regulatory, access, and commercialization activities, subject to risks and uncertainties; actual results may differ materially. Subject to applicable law, rules, or regulations, the parties undertake no obligations to update or otherwise revise the forward-looking statements in this press release, whether as a result of new information, future events or developments, or otherwise.

Judy Acidre
ACA Pharma
+1 718-790-5069
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