AUROBINDO PHARMA GETS USFDA CLEARANCE FOR RALEIGH PLANT
Hyderabad, Aug.17 (RAHNUMA): Aurobindo Pharma’s Raleigh facility in North Carolina has received a major regulatory boost after the US Food and Drug Administration (USFDA) classified its inspection as Voluntary Action Indicated (VAI) and closed the inspection. The facility, operated by Aurolife Pharma LLC, manufactures inhalers, dermatology and transdermal products. The USFDA inspected the plant from […]
CURATeQ’s OMALIZUMAB BIOSIMILAR CLEARS KEY PHASE 3 MILESTONE
Hyderabad, April 6 (RAHNUMA): CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, has announced positive top-line results from its Phase 3 trial of BP11, an investigational biosimilar to Omalizumab (marketed as Xolair). The study met all primary endpoints, demonstrating strong comparability with the reference drug in treating chronic spontaneous urticaria (CSU) at a 300 mg dose. Conducted […]
