ACA Pharma Announces Major Expansion of RYANODEX® Territory Outside the United States

Expanded collaboration significantly broadens ACA Pharma’s ex-U.S. commercialization footprint for RYANODEX®

NEW YORK, NY, UNITED STATES, November 24, 2025 /EINPresswire.com/ -- ACA Pharma today announced a significant expansion of their exclusive territory for RYANODEX^® (dantrolene sodium) outside the United States.

Ryanodex^® is indicated for the treatment of malignant hyperthermia and for the prevention of malignant hyperthermia in patients at high risk. Eagle Pharmaceuticals, Inc. is the developer and manufacturer of Ryanodex^®, and ACA Pharma acts as Eagle's primary distribution partner for Ryanodex^® outside the United States, with territory-specific exclusivities in parts of Asia, the Middle East, Europe and Latin America.

ACA Pharma has historically focused on launching RYANODEX^® in select Asia-focused markets, including Hong Kong, Macau, Singapore, the Guangdong Greater Bay Area and mainland China, India, and countries in the Gulf region. Under the expanded collaboration, ACA Pharma’s exclusive territory now covers a broad range of additional markets across Europe, Latin America, the Middle East and Asia-Pacific.

The expanded territory where ACA Pharma is the exclusive distributor now includes:

Hong Kong, Macau, Singapore, Guangdong Greater Bay Area, mainland China, India, the United Arab Emirates (“UAE”), Qatar, Kuwait, Oman, Germany, France, United Kingdom, Italy, Spain, Poland, Netherlands, Belgium, Sweden, Austria, Switzerland, Portugal, Czechia, Greece, Romania, Hungary, Denmark, Norway, Finland, Ireland, Bulgaria, Croatia, Slovakia, Slovenia, Lithuania, Latvia, Estonia, Luxembourg, Malta, Iceland, Russia; Brazil, Argentina, Chile, Peru, Columbia, Ecuador, Venezuela, Bolivia, Paraguay, Uruguay, Guyana, Suriname, Mexico; Indonesia, Philippines, Vietnam, Malaysia, Thailand, Myanmar, Cambodia, Laos; Bangladesh, Japan, South Korea, Taiwan; Pakistan; Israel; Australia, and New Zealand.

“We are honored that Eagle has entrusted ACA Pharma with an expanded ex-U.S. footprint for RYANODEX^®,” said Mike Zhou, CEO, ACA Pharma. “Building on our experience across Asia, we are now actively working with leading hospital systems, anesthesiology societies and, where appropriate, established local partners across these new markets to support registration, clinician education and reliable supply of RYANODEX^®.”

As part of this expansion, ACA Pharma is prioritizing engagement with key opinion leaders in anesthesiology and intensive care, as well as major hospital groups and qualified regional collaborators, to design tailored market-access and implementation plans for each country included in the Territory. Healthcare institutions and organizations interested in collaborating to improve local access to RYANODEX^® may contact ACA Pharma at team@acapharma.net or https://acapharma.net/.

About Eagle Pharmaceuticals, Inc.

Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients' lives. Additional information is available on Eagle's website at www.eagleus.com.

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 Ryanodex^®

• Ryanodex^® (dantrolene sodium for injection) is FDA-approved for the treatment of malignant hyperthermia in conjunction with appropriate supportive measures, and for the prevention of malignant hyperthermia in patients at high risk.
Important Safety Information
• RYANODEX^® is not a substitute for appropriate supportive measures in the treatment of malignant hyperthermia (MH), including discontinuing use of MH-triggering anesthetic agents, managing the metabolic acidosis, instituting cooling when necessary, and administering diuretics to prevent late kidney injury due to myoglobinuria (the amount of mannitol in RYANODEX^® is insufficient to maintain diuresis).
• RYANODEX^® is associated with skeletal muscle weakness such as loss of grip strength and weakness in the legs, as well as drowsiness, dizziness, dysphagia, dyspnea, and decreased inspiratory capacity. Patients should not be permitted to ambulate without assistance until they have normal strength and balance. Care must be taken to prevent extravasation of RYANODEX^® into the surrounding tissue due to the high pH of the reconstituted RYANODEX^® suspension and potential for tissue necrosis.
• RYANODEX^® full Prescribing Information can be found at www.RYANODEX.com

Judy Acidre
ACA Pharma
INFO@ACAPHARMA.NET
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