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Home Tags US-FDA

Tag: US-FDA

Zydus Therapeutics’ New Drug Application (NDA) for Saroglitazar to treat Primary Biliary Cholangitis (PBC) granted Priority Review by the US FDA
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Zydus Therapeutics’ New Drug Application (NDA) for Saroglitazar to treat Primary Biliary Cholangitis (PBC) granted Priority Review by the US FDA

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June 1, 2026
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Granules India’s Unit V Facility Secures US FDA EIR With ‘No Action Indicated’ Status
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Granules India’s Unit V Facility Secures US FDA EIR With ‘No Action Indicated’ Status

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November 8, 2024
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Centhaquine First Ever Indian Drug to get Direct Approval
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Centhaquine Set to Enter US-FDA Approved Phase 3 Clinical Trial in US and Europe: First Ever Indian Drug to get Direct Approval for such a Trial

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August 2, 2023
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