Zydus Lifesciences Limited announced the final USFDA approval for Methenamine Hippurate Tablets. This brings an important enhancement to Zydus's strengthening portfolio of urological therapeutics.
Most significant points:
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The approved therapeutic is indicated in the treatment and prevention of urinary tract infections
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Methenamine Hippurate Tablets will be produced at the state-of-the-art formulation center of Zydus in India
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This approval further consolidates Zydus's position in the U.S. pharma market
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The approval of Methenamine Hippurate Tablets is consistent with Zydus's plan to build up its specialty pharmaceutical business. It is just the latest FDA approval for other medications, such as Dasatinib Tablets to treat leukemia.
Zydus continues to show regulatory compliance and manufacturing mettle, with its Ambernath API plant having just cleared an FDA inspection with zero observations. The recent approval is likely to add to the firm's increasing U.S. formulations sales, which grew 29% year-on-year in the previous quarter.
Source: Based on Zydus Lifesciences' recent regulatory filings and FDA approvals, reported by FirstWord Pharma and CNBC TV18.