Alembic Pharmaceuticals receives USFDA final approval for Lamotrigine Extended-Release Tablets
Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures
Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures
The inspection conducted by EDQM at its Visakhapatnam facility
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
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