Lupin Limited has announced that the United States Food and Drug Administration (USFDA) completed an inspection of its Nagpur Injectable facility between September 8 and September 16, 2025. The inspection concluded with six observations.
The company confirmed that it will address the concerns raised by the regulator and submit its response within the stipulated timeframe. Lupin emphasized that it remains committed to maintaining compliance with Current Good Manufacturing Practice (CGMP) quality standards across all its facilities.
This development is significant as injectable facilities form a critical part of Lupin’s global product portfolio, particularly for the US market. The company did not disclose the specific nature of the six observations but assured that necessary corrective measures will be implemented to align with regulatory expectations.
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