Alembic Pharmaceuticals Secures USFDA Final Approval for Dexlansoprazole Capsules

Vadodara, November 13: Alembic Pharmaceuticals Limited has announced that it has received final approval from the United States Food and Drug Administration for its Dexlansoprazole Delayed-Release Capsules in 30 mg and 60 mg strengths. As a result, its share price rose 0.15%.

Alembic Pharmaceuticals (NSE: APLLTD, BSE: 533573) is an Indian multinational pharmaceutical company. The company is involved in the manufacturing and global marketing of generic pharmaceutical products, pharmaceutical substances, and intermediates. It is known for being a market leader in the macrolides (anti-infective) segment in India. The company was established in 1907, and is headquartered in Vadodara, Gujarat.

Key Details About the Approval

The company announced the approval by the United States Food and Drug Administration is regarding its Abbreviated New Drug Application for Dexlansoprazole. It is a proton pump inhibitor used for healing erosive esophagitis. It is also used for maintaining healed esophagitis and relief from heartburn, and treating symptomatic non-erosive gastroesophageal reflux disease in patients aged 12 and above. With this approval, Alembic’s ANDA count has risen to 229. It now includes 209 final approvals and 20 tentative approvals.

Shares Rise 0.15% At ₹918

As of 2:10 PM, Alembic Pharmaceuticals share price was up by 0.15%, or 1.35 points, and was trading at ₹918. The traded volume stood at 55.73 thousand shares, with the company’s market cap at ₹18,018 crore.

Investor Takeaway for Alembic Pharmaceuticals

The approval secured by Alembic Pharmaceuticals is a welcome step for the company. It has contributed to its line of pharmaceuticals, and its sale will contribute to revenue in the coming quarters. The announcement has boosted investor demand, leading to a rise in share price.

REF: https://nsearchives.nseindia.com/corporate/APLLTD_13112025114754_Intimation_to_SE_Press_Release_FA.pdf

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