USFDA inspects Gland Pharma’s Dundigal facility
The inspection was concluded with two 483 observations
The inspection was concluded with two 483 observations
Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials
EBITDA grew by 31% YoY with EBITDA margin of 11%, a YoY improvement of over 170bps vs. Q1FY24
The product is bioequivalent and therapeutically equivalent to the reference listed drug
The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India
Reported profit after tax declined 19% year-on-year to Rs 76 crores
The inspections concluded with no Form 483 observations or significant critical findings
The integrated company delivers a broad portfolio of over 30,000 lab products across microscopy, histology, and other research areas
Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension
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