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FDA inspection reveals critical supply chain vulnerabilities
Amanda Murphy, Senior Director at GlobalData, discusses how real-time intelligence can turns regulatory events into opportunities.
An analysis of federal data shows a pronounced decline, despite alarming conditions found at some manufacturers.
A U.S. representative is pressing the FDA for information about ByHeart Inc., the company linked to an outbreak of infant ...
Lupin has announced that the United States Food and Drug Administration's inspection of its Nagpur facility has come to a ...
HMP Inspectorate of Prisons said that progress tackling an 'entrenched drug culture' had been 'far from sufficient' at HMP ...
Global pharma major Lupin Limited, in an exchange filing announced that the United States Food and Drug Administration (U.S.
Lupin announced that the US Food and Drug Administration (USFDA) has successfully completed a product-specific pre-approval inspection at its Unit-1 oral solid dosage facility in Nagpur.
The active pharmaceutical ingredient (API) facility (CTO-SEZ) of Dr. Reddy’s in Srikakulam was inspected between November 10 and November 14, 2025 ...
The U.S. FDA inspection of the facility, Unit-II in Bhiwadi, Alwar, from November 3-14 concluded with nine observations. They are procedural in nature and will be responded to within the stipulated ...
The FDA’s new Commissioner’s National Priority Voucher signals a transformative shift in U.S. drug review, tying accelerated approval to manufacturing readiness, domestic supply-chain strength, and ...
The baby formula company whose products have been linked to a botulism outbreak that has sickened at least 23 infants stopped ...
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