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Lupin Limited
5 articles
Lupin Limited is expanding its regulatory footprint and product offerings, signaling continued growth potential. Recent approvals from the US FDA and European Medicines Agency (EMA) are key highlights, with the EMA nod extending NaMuscla's indication to pediatric patients and the FDA granting tentative approval for Enzalutamide tablets, offering additional treatment options for prostate cancer. Simultaneously, the company strengthened its control over its Philippine subsidiary, MPPI, increasing its stake to nearly 99.9%, and received a positive FDA inspection classification for its Somerset facility, reinforcing its commitment to quality and operational excellence. These developments collectively suggest a positive trajectory for Lupin, though investors should monitor the timeline for local implementation of new dosages and the impact of tentative FDA approvals.
Lupin Receives FDA VAI Classification for Somerset Facility
Lupin received FDA Establishment Inspection Report with Voluntary Action Indicated classification for its Somerset, New Jersey manufacturing facility.
The satisfactory inspection outcome confirms regu
Lupin Subsidiary Increases MPPI Stake to 99.89%
Lupin's Dutch subsidiary Nanomi completed acquisition of 11.79 million MPPI shares from existing shareholders.
MPPI subsidiary also completed buyback of 61,118 shares with another 30,559 shares buybac
Lupin Receives EMA Approval for NaMuscla Pediatric Expansion
Lupin announced EMA approval for NaMuscla expansion to pediatric patients aged 6-17 years with non-dystrophic myotonic disorders.
The approval includes two new dosage strengths (62 mg and 83 mg capsul
Lupin Grants 65,251 ESOPs at ₹2 Exercise Price
Lupin's NRC approved a grant of 65,251 employee stock options under its 2025 scheme on June 30, 2026.
Each option has an exercise price of ₹2.00 and entitles the holder to one equity share upon vestin
Lupin Receives Tentative US FDA Enzalutamide Approval
Lupin received tentative FDA approval for Enzalutamide Tablets in 40mg, 80mg, 120mg, and 160mg strengths.
The tablets are bioequivalent to Astellas' Xtandi® for prostate cancer treatment with addition