Ahmedabad-headquartered drug maker Zydus Lifesciences said on Tuesday that it had received final approval from the US Food and Drug Administration (FDA) for producing verapamil hydrochloride extended-release tablets, used in treating high blood pressure. The tablet has an estimated market of $24.5 million in the US. The tablets, said the pharmaceutical company, will be produced at its facility in Baddi, Himachal Pradesh.
The approval covers the 120 mg, 180 mg and 240 mg variants of the drug. according to a regulatory filing.
Zydus Lifesciences wins FDA nod for high blood pressure treatment drug
Annual sales of the drug in the US are estimated at $24.5 million (around Rs 218 crore).
With the latest FDA nod in place, the Zydus group has taken the total number of approvals secured from the US regulator to 428.
Zydus Life signs agreement with US-based pharma firm
Separately, Zydus Lifesciences and US-based RK Pharma have signed an exclusive licensing and commercialisation deal for “a novel sterile injectable 505(b)(2) oncology supportive care product” for the US market.
Under the terms of this agreement, said Zydus Life, RK Pharma will manufacture and supply the finished product, while Zydus will be responsible for the NDA submission and commercialization of the product in the US.
“The product, developed under the 505(b)(2) pathway, is expected to be filed in 2026 and will provide a formulation that is intended to provide reduced dosing error and enhanced compliance of healthcare professionals,” added the Ahmedabad-based company.
Zydus Lifesciences shares
The Zydus Life stock — traded with the symbol ZYDUSLIFE on stock exchanges BSE and NSE — rose as much as 1.7 per cent to Rs 943.5 apiece on BSE, on track to finish higher for the third session in a row.
FDA approvals are generally viewed positively by analysts, especially when linked to sizeable products.
At the current level, Zydus Life shares are down 3.2 per cent so far this year, in line with a 2.9 per cent decline in the Nifty Pharma though better than a 10 per cent gain in the Nifty50.
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