Browsing Tag
USFDA
32 posts
Zydus Lifesciences Q2 profit jumps 38% as US and China approvals sharpen global expansion strategy
Zydus Lifesciences Limited reports strong Q2 FY26 results and secures post-earnings approvals in the United States and China. Read more on investor sentiment and next steps.
Zydus Lifesciences stock edges higher as Sentynl faces FDA CRL for CUTX-101
Zydus Lifesciences’ U.S. unit Sentynl received an FDA Complete Response Letter for CUTX-101. Find out why investors remain optimistic despite regulatory delays.
Solara Active Pharma’s Ambernath site clears third consecutive USFDA audit with Zero 483 observations
Solara’s Ambernath facility clears USFDA audit with zero 483s, boosting investor confidence despite financial caution. Read why institutions are watching closely.
Aarti Drugs soars with Q4 FY25 profit spike—But what’s behind the full-year revenue drop?
Aarti Drugs Q4 FY25 profit rose 33% YoY as exports rebounded, but full-year revenue declined 5%. See what’s behind the surge—and the challenges ahead.
Aurobindo Pharma wins key FDA approval for blockbuster blood thinner in $8.5bn US market
Aurobindo Pharma gets USFDA final approval for Rivaroxaban 2.5mg and tentative nod for other doses. Find out what this means for its US market strategy.
Zydus wins FDA nod for DMD drug Jaythari—what it means for rare disease treatment and its stock
Find out how Zydus Lifesciences is expanding rare disease care and investor value with USFDA-approved Jaythari tablets for Duchenne muscular dystrophy.
Orchid Pharma secures USFDA approval, reinforcing global leadership in sterile cephalosporins
Orchid Pharma Limited has reaffirmed its position as a leading pharmaceutical manufacturer with the successful completion of a…
Aurobindo Pharma achieves record revenue in Q3 FY25 despite profit decline
Aurobindo Pharma Limited has reported its highest-ever quarterly revenue for the third quarter of fiscal year 2025, underlining…
Zydus Lifesciences posts strong Q3 FY25 results with 30% net profit surge
Zydus Lifesciences Limited has reported robust financial performance for the third quarter of fiscal year 2025, driven by…
Aarti Drugs faces revenue decline amid API Market challenges in Q3 FY25
Aarti Drugs Limited, a Mumbai-based pharmaceutical company engaged in Active Pharmaceutical Ingredients (API), formulations, specialty chemicals, and intermediates,…