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Alembic Pharma Gains USFDA Approval for Generic Hypertension Drug

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Synopsis:

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 Pharma news today

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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ALEMBIC PHARMA LTD

Trade

1019.50.00 (0.00 %)

Updated - 13 November 2024
1038.40day high
DAY HIGH
999.95day low
DAY LOW
146013
VOLUME (BSE)

Key Takeaways:

  • 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.

Market and Product Overview

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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Stock Performance

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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Recent Developments and Company Overview

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.

Disclaimer: Investments in the securities market are subject to market risk, read all related documents carefully before investing.

This content is for educational purposes only. Securities quoted are exemplary and not recommendatory.

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