Alembic gets USFDA nod for Dasatinib Tablets

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

+0.9%Reaction day

₹913.00

prior close

₹914.95

announcement price

In-mkt

timing

Nifty Microcap 250market · index membership as recorded later (tracked since Jun 2026)+0.4%+0.5% vs market

Pharmaceuticals peers, median of 156sector-0.1%+0.9% vs sector

On the reaction day the stock moved 0.5 pts more than Nifty Microcap 250 and 0.9 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

+0.1

10m

-0.9

15m

-0.8

30m

-0.8

Sessions after the filingfrom the prior close

StockMarketvs marketSectorvs sector

Reaction day

+0.9+0.4+0.5-0.1+0.9

Next day

+1.4+0.0+1.3-0.7+2.1

+0.5-0.2+0.7-1.0+1.5

+0.7+0.7-0.0+0.1+0.6

+0.5+0.6-0.1+0.2+0.3

-1.0+0.5-1.5+0.0-1.0

+0.3+0.3+0.0-0.3+0.7

15d

-0.5-1.5+0.9-1.7+1.2

-3.4-6.6+3.1-5.4+2.0

-10.0-3.2-6.8-2.8-7.2

-12.8-5.2-7.6-7.3-5.5

UpDownMarket · Nifty Microcap 250Sector · Pharmaceuticals peers, median of 156Pending

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

AI summary

Alembic Pharmaceuticals received USFDA final approval for Dasatinib Tablets in 6 strengths (20, 50, 70, 80, 100, and 140 mg), a generic equivalent of Bristol-Myers Squibb's Sprycel used to treat certain types of leukemia. The US addressable market for this drug is about US$1,017 million over 12 months ending September 2025, per IQVIA. This takes Alembic's cumulative ANDA tally to 227 (207 final and 20 tentative).

Likely market impact

Positive — opens access to a roughly US$1 billion US generic market and strengthens Alembic's US portfolio.