Zydus Lifesciences has received final approval from the U.S. Food and Drug Administration (USFDA) for its Verapamil Hydrochloride Extended-Release Tablets. This milestone allows Zydus to market its cardiac medication in the U.S., enhancing its pharmaceutical portfolio and boosting its presence in the key U.S. market.
Zydus Lifesciences, a prominent pharmaceutical company, has secured the final USFDA approval for Verapamil Hydrochloride Extended-Release Tablets in 120 mg, 180 mg, and 240 mg strengths. Verapamil hydrochloride is a calcium channel blocker widely prescribed for treating hypertension, angina, and certain heart rhythm disorders. The extended-release formulation offers controlled drug release, improving patient compliance and therapeutic efficacy.
This regulatory approval marks a significant step in Zydus’ expansion into the highly competitive U.S. pharmaceutical market, allowing the company to market and distribute this cardiac drug effectively. The U.S. market’s large scale provides Zydus with an opportunity to enhance its revenue streams and strengthen its global market position.
Key Highlights:
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Product: Verapamil Hydrochloride Extended-Release Tablets (120 mg, 180 mg, 240 mg)
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Regulatory Body: U.S. Food and Drug Administration (USFDA)
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Approval: Final approval for marketing and distribution in the U.S.
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Medical Usage: Treatment of hypertension, angina, and certain arrhythmias
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Market Impact: Expansion of Zydus’ presence and portfolio in the U.S. pharmaceutical market
Sources: Zydus Lifesciences official announcements, ScanX Trade News, The Hindu Business Line, MoneyRediff, Express Pharma.