Zydus Lifesciences Limited has informed the Exchange regarding a press release dated August 11, 2025, titled "Zydus receives final approval from USFDA for Diltiazem Hydrochloride Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg".

Regulatory product approvalBusiness Updates View source PDF Explain this filing

ZYDUSLIFE · 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

+2.2%Reaction day

₹934.20

prior close

₹940.70

announcement price

In-mkt

timing

Nifty 100market · index membership as recorded later (tracked since Jun 2026)+1.0%+1.3% vs market

Pharmaceuticals peers, median of 148sector+0.3%+1.9% vs sector

On the reaction day the stock moved 1.3 pts more than Nifty 100 and 1.9 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

+0.2

15m

+0.3

30m

+0.5

Sessions after the filingfrom the prior close

StockMarketvs marketSectorvs sector

Reaction day

+2.2+1.0+1.3+0.3+1.9

Next day

+2.2+0.6+1.6+0.3+1.9

+5.7+1.2+4.5+0.6+5.1

+5.5+1.2+4.4-0.3+5.9

+5.9+2.2+3.6+0.4+5.5

+6.0+2.7+3.2+0.6+5.4

+5.6+3.1+2.5+0.6+5.0

15d

+8.2+1.7+6.5+0.1+8.1

+11.9+2.8+9.0+1.3+10.5

+6.4+3.7+2.7-1.6+8.0

+0.5+5.6-5.2-4.4+4.8

UpDownMarket · Nifty 100Sector · Pharmaceuticals peers, median of 148Pending

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

AI summary

Zydus Lifesciences has received final approval from the USFDA to market Diltiazem Hydrochloride Tablets in four strengths (30 mg, 60 mg, 90 mg, and 120 mg) in the United States. The drug is a generic equivalent of Cardizem® Tablets, used for treating chronic stable angina and angina caused by coronary artery spasm, and belongs to the calcium-channel blocker class. Production will take place at Zydus's Baddi facility in Himachal Pradesh. The US market for this drug is valued at USD 13.9 million annually (IQVIA MAT June 2025). With this approval, the group has now received 423 approvals and filed 483 ANDAs cumulatively since FY 2003-04.

Likely market impact

This is a positive but modest addition to Zydus's US generics portfolio — the USD 13.9 mn addressable market is relatively small, so near-term revenue impact will be limited, though it strengthens the company's ongoing ANDA pipeline and US presence.