- Pharma
- 1 min read
Glenmark Pharma shares slip after USFDA puts plant under import alert
Glenmark Pharmaceuticals on Wednesday said the US health regulator has put its plant at Baddi under import alert. The drugs produced at the Baddi unit can now be detained without physical examination.
Glenmark Pharmaceuticals on Wednesday said the US health regulator has put its plant at Baddi under import alert. The drugs produced at the Baddi unit can now be detained without physical examination.
The US Food and Drug Administration inspected the facility in June 2022 and subsequently placed it under "official action indicated" status.
The OAI classification implied that the USFDA may withhold approval of any pending product applications or supplements filed from such facility till the outstanding observations related to non-compliance with manufacturing norms laid down by the regulator.
"We now wish to inform you that the US FDA has placed the Baddi (India) facility under import alert 66-40," Glenmark Pharmaceuticals said in a regulatory filing.
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