US FDA

Glenmark Pharma gets US FDA approval for skin cream generic

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Glenmark receives ANDA tentative approval for Dapagliflozin Tablets, 5 mg and 10 mg

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Dr Reddy’s launches generic opioid antagonist injection in US

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Dr Reddy’s launches generic Ziprasidone Mesylate for injection in US

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Coronavirus (COVID-19) update: FDA issues guidance for conducting clinical trials

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Alembic Pharma receives four observations from USFDA for Panelav facility

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Alkem Labs gets EIR from US FDA for Baddi facility

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USP’s public standard-setting process is very rigorous

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US FDA postpones foreign inspections over coronavirus outbreak

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US FDA concludes SMS Pharma’s inspection with zero observation

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