Alembic Pharmaceuticals share price rose 2 percent in the opening trade on November 17 following the company received final approval from USFDA for angina drug.
At 09:19am, Alembic Pharmaceuticals was quoting at Rs 922.30, up Rs 19.50, or 2.16 percent, on the BSE.
".... 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," company said in its press release.
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Cardizem Tablets, 30 mg, 60 mg, 90 mg, and 120 mg, of Bausch Health US, LLC.
Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm, it added.
With this, the company has a cumulative total of 230 ANDA approvals (210 final approvals and 20 tentative approvals) from USFDA.
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On November 13, the company received final approval from the for its ANDA Dexlansoprazole Delayed-Release Capsules, 30 mg and 60 mg, which is therapeutically equivalent to the reference listed drug (RLD), Dexilant Delayed-Release Capsules, 30 mg and 60 mg, of Takeda Pharmaceuticals USA, Inc.
On November 7, the company received final USFDA approval for its ANDA Sumatriptan Injection USP, 4 mg/0.5 mL and 6 mg/0.5 mL, Single-Dose Autoinjector System.
Sumatriptan injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. Refer label for a detailed indication.
In the previous trading session, the share closed at Rs 902.80, down Rs 14.50, or 1.58 percent.
The share touched a 52-week high of Rs 1,122.40 and a 52-week low of Rs 725.60 on 06 January, 2025 and 03 March, 2025, respectively.
Currently, the stock is trading 17.83 percent below its 52-week high and 27.11 percent above its 52-week low.
The market capitalisation of the company stands at Rs 18,129.02 crore.
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