The latest approval covers Diltiazem Hydrochloride Tablets USP in strengths of 30 mg, 60 mg, 90 mg and 120 mg. The product is therapeutically equivalent to Bausch Health’s Cardizem Tablets and is indicated for the management of chronic stable angina and angina caused by coronary artery spasm.

Earlier this month, the company also secured approval for Dexlansoprazole Delayed-Release Capsules (30 mg and 60 mg), a proton pump inhibitor indicated for healing and maintenance of erosive esophagitis, relief of heartburn and treatment of symptomatic nonerosive gastroesophageal reflux disease (GERD) in patients aged 12 years and older. The product is a generic version of Takeda’s Dexilant Delayed-Release Capsules. The product is a generic version of Takeda’s Dexilant Delayed-Release Capsules.

In addition, Alembic received final approval for Sumatriptan Injection USP (4 mg/0.5 mL and 6 mg/0.5 mL), supplied as a single-dose autoinjector system. This is the company’s first drug–device combination product and is therapeutically equivalent to GlaxoSmithKline’s Imitrex STATdose System, indicated for the acute treatment of migraine and cluster headache in adults.

The company also secured approval for Dasatinib Tablets in multiple strengths ranging from 20 mg to 140 mg, a therapeutic equivalent to Bristol-Myers Squibb’s Sprycel. Dasatinib is used in the treatment of various Philadelphia chromosome–positive leukemias in both adults and pediatric patients.

With these approvals, Alembic’s cumulative ANDA count has reached 230, comprising 210 final approvals and 20 tentative approvals.

For the quarter ended 30 September 2025, Alembic Pharmaceuticals reported a 16 percent increase in consolidated revenue from operations, reaching INR 1,910 crore. EBITDA rose 26 percent to INR 325 crore, representing a 17 percent margin, while profit after tax increased 20 percent to INR 185 crore.

Commenting on the results, Shaunak Amin MD, Alembic Pharmaceuticals, said the Q2 performance reflects “continued momentum in our core businesses and the disciplined execution.”

He also highlighted the completion of the acquisition of Utility Therapeutics, which provides the company “a segway in to branded drugs in the US.”