Shares of Alembic Pharmaceuticals Ltd rallied 4% on Monday, 17 November, after the company announced securing final approval from the USFDA for its angina medication.

In its regulatory filing, the company said, “Alembic Pharma has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Diltiazem Hydrochloride Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg.”

The authorised ANDA is medically comparable to Bausch Health US, LLC’s Cardizem Tablets in strengths of 30 mg, 60 mg, 90 mg, and 120 mg.

It noted that diltiazem hydrochloride tablets are used to treat chronic stable angina as well as angina caused by coronary artery spasm.

This brings the company’s overall ANDA approvals from the USFDA to 230 (210 final and 20 tentative).

Earlier, on 13 November, the company got final approval for its ANDA Dexlansoprazole Delayed-Release Capsules, 30 mg and 60 mg, which are medically similar to Takeda Pharmaceuticals USA, Inc.’s reference listed drug (RLD), Dexilant Delayed-Release Capsules, 30 mg and 60 mg.

On 7 November, the company gained final approval from the FDA for its ANDA Sumatriptan Injection USP, 4 mg/0.5 mL and 6 mg/0.5 mL, Single-Dose Autoinjector System.

Sumatriptan injection is used in adults to treat (1) acute migraine, with or without aura, and (2) acute cluster headache.

At 12:50 pm, the shares of Alembic Pharma were trading 3.51% higher at Rs 934.35 on NSE. 

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