Drug Approval | June 29, 2025
Briefs: Neuland Laboratories and Granules India
Granules India receives 1 observation from USFDA for Chantilly facility
Granules India receives 1 observation from USFDA for Chantilly facility
The GMP-compliant facility with automated environmental monitoring accommodates both white room and class 7 and 8 cleanroom space
The 16,000-square-foot expansion enhances DuPont’s global sterile operations
The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance
Facility also named 2025 ISPE Facility of the Year Winner for Social Impact - Unmet Medical Needs
Allopurinol is used to prevent or lower high uric acid levels in the blood
Certification bolsters Venus Remedies' position in PIC/S markets, reinforcing commitment to global quality standards
For the full financial year FY25, revenue from operations grew 9 per cent to Rs. 11,537.8 crore, compared to Rs. 10,588 crore in FY24.
CuraTeQ Biologics receives approval for biosimilar Zefylti from UK’s MHRA
This outcome reflects Innoxel Lifesciences' ongoing commitment to maintaining the highest standards of quality, compliance, and regulatory excellence
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