Alembic Pharma gets USFDA approval for Difluprednate eye drops

Regulatory Product ApprovalBusiness Updates View source PDF Explain this filing

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Price reactionminutes from the announcement price · days from the prior close

-0.4%Reaction day

₹765.00

prior close

₹759.50

announcement price

In-mkt

timing

Nifty Microcap 250market · index membership as recorded later (tracked since Jun 2026)+0.1%-0.5% vs market

Pharmaceuticals peers, median of 154sector-0.4%-0.0% vs sector

On the reaction day the stock moved 0.5 pts less than Nifty Microcap 250 and in line with its Pharmaceuticals peers, over the same two closes: a difference in percentage points, not a measure of what the filing did.

Minutes after the announcementfrom the announcement price · no benchmark

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Sessions after the filingfrom the prior close

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Reaction day

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Next day

+0.6+2.2-1.5+0.0+0.6

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+2.6+3.6-1.0+0.0+2.6

+3.9+2.3+1.6-0.2+4.2

+3.6+6.1-2.5+2.3+1.3

+5.5+6.4-1.0+1.9+3.6

15d

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-0.4+12.5-12.8+4.3-4.7

UpDownMarket · Nifty Microcap 250Sector · Pharmaceuticals peers, median of 154Pending

Minute windows have no benchmark: there is no intraday index history to compare against.

AI summary

Alembic Pharmaceuticals received final USFDA approval for Difluprednate Ophthalmic Emulsion 0.05 percent, a generic equivalent of Sandoz Durezol. It is used to treat inflammation and pain after eye surgery and for anterior uveitis. This takes Alembic cumulative ANDA approvals to 233, including 213 final and 20 tentative approvals from USFDA.

Likely market impact

Positive for US business. Strengthens Alembic ophthalmology portfolio and adds another generic launch opportunity in the US.