News about "Official Action Indicated Status"

Aurobindo Pharma Unit Receives US FDA Warning Letter; No Impact on US Supplies

Aurobindo Pharma Unit Receives US FDA Warning Letter; No Impact on US Supplies

Aurobindo Pharma’s Eugia Pharma Specialities has received a US FDA warning letter for its Telangana facility, while the company said existing US supplies remain unaffected.

Official Action Indicated Status | 14/08/2026 | By News Bureau |  222

FDA Flags Lupin's Pithampur Manufacturing Facility with Official Action Indicated Status

FDA Flags Lupin's Pithampur Manufacturing Facility with Official Action Indicated Status

Lupin stated that it is actively engaging with the U.S. regulator and remains committed to maintaining full compliance with current Good Manufacturing Practice (cGMP) standards across all its manufacturing sites.

Official Action Indicated Status | 06/10/2025 | By Darshana |  667


 

 

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