Drug Approval | September 29, 2024
Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma
Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations
Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations
The Shasta system and Shasta Whole-Genome Amplification (WGA) Kit dramatically increase throughput for WGA by processing up to 1,500 cells per run
The sample seized by CDSCO is not manufactured by Torrent and is in fact non-genuine and spurious
At 24 months, data from the Phase 1 exPDite trial continue to show a favorable safety profile in all 12 participants in the trial’s high and low dose cohorts
This approval reflects company’s unwavering commitment that the quality assurance
New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids
Glenmark Pharmaceuticals Limited has informed that the USFDA has issued Form 483 with zero observations
Stable profits, low leverage to keep credit profiles comfortable
Based out of Boston, Vivek will build on the foundation created by Vaidheesh, and will help build a stronger customer connect and further drive global expansion of the platform
USFDA concludes inspection of Dr. Reddy's Laboratories R&D centre in Bachupally with zero observation
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