ACA Pharma, an end-to-end commercialization partner for China & Southeast Asia, helps Eagle Pharmaceuticals secure regulatory approval in Macau for RYANODEX in under 90 days.
ACA Pharma proudly announces the rapid regulatory approval of Ryanodex (dantrolene sodium) in Macau, in collaboration with Eagle Pharmaceuticals. Achieved within an impressive 90 days and without local clinical trials, this milestone significantly enhances emergency medical response capabilities.
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Ryanodex offers critical advantages in emergency settings, notably its ultra-fast reconstitution time—just one minute compared to the standard 20 minutes required by existing alternatives. This difference is potentially lifesaving during acute medical emergencies.
Achieving regulatory approval in just 90 days demonstrates our commitment to accelerating lifesaving treatments in critical emergency settings.
Registration processes for Ryanodex are also currently underway in Hong Kong and Singapore, regions known for their robust government-backed insurance support for innovative treatments.
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Following receipt of the final drug certificate and associated regulatory documents, ACA Pharma has initiated discussions with Guangdong Greater Bay Area (GBA) authorities to begin immediate market entry into Mainland China via 45 leading hospitals in the region and to pursue fast-track national registration in China via the clinical urgent-use pathway, which similarly circumvents the requirement for local clinical trials.
ACA Pharma’s Macau team maintains a distinguished track record, successfully completing 54 fast-track new drug registrations over the past two years, representing U.S. and European pharmaceutical innovators, all achieved with a 100% approval rate.
This approval underscores ACA Pharma’s ongoing commitment to facilitating expedited market access in China through its exclusive regulatory pathway in Macau, continuing its successful collaboration with global biopharma leaders like Eagle Pharmaceuticals.
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Source – PR Web
