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Zydus Cadila has received the US health regulator’s nod to market Diltiazem Hydrochloride capsules, used to treat high blood pressure, angina (chest pain) and certain heart rhythm disorders, in the American market.
The company has received final approval from the US Food and Drug Administration (USFDA) to market Diltiazem Hydrochloride extended release capsules USP in strengths of 120mg, 180mg, 240mg, 300mg and 360mg, Zydus Cadila said in a BSE filing today.
The company will manufacture the product at its formulation manufacturing facility at the Pharma SEZ in Ahmedabad.
As per IMS MAT August 2017 data, Diltiazem has an estimated sale of $191.1 million, it added.
The Gujarat-based company has more than 140 approvals and has so far filed over 300 abbreviated new drug applications (ANDAs) since it commenced filings in 2003-04.
Shares of Cadila Healthcare, the listed entity of the Zydus group were trading at Rs 492 per scrip on BSE, down 7.20 per cent from the previous close.
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