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".
ZYDUSLIFE · price
▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.
Awaiting price reaction for this filing.
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.
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.