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Alembic Pharmaceuticals Ltd has received USFDA approval for Diltiazem Hydrochloride Extended-Release capsules in multiple dosages, strengthening its U.S. generics portfolio. Alembic Pharma share price saw notable intraday movement following the announcement.
Alembic Pharmaceuticals Ltd announced that it received final USFDA approval for its Diltiazem Hydrochloride Extended-Release capsules, a hypertension treatment. This approval allows Alembic to launch the generic equivalent of Cardizem CD capsules, a brand marketed by Bausch Health in the United States. Available in dosages of 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg, these capsules cater to the U.S. market, where the product’s estimated market size is $105.3 million.
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Drug Approval: Diltiazem Hydrochloride Extended-Release capsules approved by USFDA.
Dosage Range: 120 mg to 360 mg.
Market Value: $105.3 million for Diltiazem Hydrochloride Extended-Release.
Alembic Pharma Share Price: Closed at ₹1018.15, with notable intraday movements.
Diltiazem Hydrochloride Extended-Release capsules treat hypertension, either as a standalone treatment or combined with other antihypertensive drugs. They are also prescribed for chronic stable angina and angina related to coronary artery spasms. This approval contributes to Alembic’s generics portfolio in the U.S., a growing market for the company, which now holds 218 cumulative Abbreviated New Drug Application (ANDA) approvals from the USFDA, including 191 final approvals and 27 tentative approvals.
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Alembic Pharma share price opened at ₹1039.00 on the BSE, surged by 2.4% to an intraday high of ₹1064.15, before easing back to ₹1018.15. This volatility reflects investor interest following the regulatory approval.
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This new approval follows the recent successful inspection of Alembic’s oncology facility in Gujarat by the USFDA, underscoring Alembic’s strong compliance standards. Established in 1907, Alembic Pharma has built a reputation for advanced research and development, backed by its state-of-the-art manufacturing capabilities in multiple locations. The company leads in branded generics in India, supported by a large field force and approved facilities globally, including the United States.
Alembic Pharma’s latest USFDA approval for Diltiazem Hydrochloride Extended-Release capsules enhances its U.S. market presence. With this addition, Alembic is poised for continued growth in the generics sector, supported by its robust manufacturing and regulatory compliance. The Alembic Pharma share price may continue to attract investor interest as the company expands its portfolio.
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