USFDA approves Alembic's Valganciclovir oral solution

Regulatory Product ApprovalBusiness Updates View source PDF Explain this filing

APLLTD · price

Loading chart…

▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.

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

+1.9%Reaction day

₹772.00

prior close

₹769.95

announcement price

After-mkt

timing

Nifty Microcap 250market · in no size index; the smallest one is usedpendingvs market: pending

Pharmaceuticals peers, median of 170sector+0.6%+1.4% vs sector

On the reaction day the stock moved 1.4 pts more than 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

Stock

+0.5

10m

+0.4

15m

+0.5

30m

+1.0

Sessions after the filingfrom the prior close

StockMarketvs marketSectorvs sector

Reaction day

+1.9pendingpending+0.6+1.4

Next day

—————

15d

—————

UpDownMarket · Nifty Microcap 250Sector · Pharmaceuticals peers, median of 170Pending

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

AI summary

Alembic received final USFDA approval for its generic Valganciclovir oral solution, 50 mg/mL, equivalent to Valcyte. It treats cytomegalovirus retinitis in patients with AIDS and prevents the disease in certain transplant patients. Alembic now has 247 USFDA generic drug approvals, including 227 final and 20 tentative approvals.

Likely market impact

Adds a product for the US market and strengthens Alembic's export portfolio, supporting potential revenue growth.