Alembic Pharmaceuticals informed the exchanges that it has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Tablets USP in 30 mg, 60 mg, 90 mg, and 120 mg strengths. The company announced the approval on Saturday, November 15.
Key approval for a cardiovascular therapy
The drug, used to treat high blood pressure and angina, has been cleared as therapeutically equivalent to the reference listed drug Cardizem Tablets of Bausch Health US, LLC. The tablets are indicated for the management of chronic stable angina and angina caused by coronary artery spasm.
With this clearance, Alembic now holds a cumulative total of 230 ANDA approvals from the USFDA, including 210 final approvals and 20 tentative approvals.
Shares of Alembic Pharmaceuticals settled 1.28% lower on Friday at Rs 904.20. The stock has declined 14% so far in 2025.Also read | Tata Motors CV hits top gear on debut post demerger. Here are 7 takeaways from the listing(Disclaimer: Recommendations, suggestions, views, and opinions given by the experts are their own. These do not represent the views of The Economic Times)
