Pharmaceutical manufacturer Wanbury Limited (WL) has strengthened its position in the Brazilian market after securing regulatory approval for Sertraline Form II from Brazil’s health regulator, ANVISA
The protections extend through at least 2035, with the potential for further extensions
Launches advanced bone density systems in India & Dubai
The collaboration will leverage this clinical experience to inform NCEL-101 development, streamline regulatory pathways, and potentially accelerate timelines for achieving durable graft survival comparable to donor human islets
The initiative provides clearer regulatory guidance and a defined path from research in space to patient access on Earth
The first of four planned modules at the new plant is expected to come online by summer 2026
The conditional, time-limited approval comes through a joint effort with RACTHERA, a joint venture in which Sumitomo Chemical holds a 66.6% stake and Sumitomo Pharma holds 33.4%
The company will address the observations and respond to the U.S. FDA within the stipulated timeframe
The inspection concluded with zero observations, confirming the facility's compliance with current Good Manufacturing Practices
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