Quality under pressure: Strengthening continuity amid geopolitical uncertainty
One of the most persistent risks facing Indian pharma manufacturers is the industry's heavy dependence on China for KSMs and…
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Browsing Tag
Pharmaceutical compliance
Lupin receives EIR from U.S. FDA for Aurangabad facility
The Establishment Inspection Report follows a product-specific Pre-Approval Inspection conducted by the U.S. FDA at Lupin’s…
USFDA classifies Hyderabad FDF Unit-I of Cohance Lifesciences as Official Action Indicated
Company initiates remediation measures; confirms limited revenue contribution from the facility and no material impact on…
Dr Reddy’s Labs gets US FDA clearance: Visakhapatnam facilities classified as VAI
USFDA concludes inspection of Dr Reddy's Visakhapatnam units with Voluntary Action Indicated status