Lupin’s injectable facility in Nagpur has received six observations from the US Food and Drug Administration (USFDA), following an inspection conducted between the 8th and 16th of September 2025. The company confirmed in a stock exchange filing that it will respond to the observations within the timeframe stipulated by the USFDA and remains committed to maintaining cGMP (current Good Manufacturing Practice) standards at all its sites.

While Lupin has not disclosed the specific nature of these observations, they are considered early warnings of potential compliance issues. Such observations allow the company to take corrective actions before they escalate into more serious regulatory actions. The firm emphasised that it is fully dedicated to addressing any gaps identified and ensuring quality compliance across its operations.

The inspection results are closely watched by industry analysts, as Lupin serves a global market with injectable products. Maintaining regulatory compliance is crucial not only for continued access to international markets, but also for preserving investor confidence and reputation. Lupin’s statement reaffirmed its intention to align with global quality norms and to swiftly resolve the concerns raised by the FDA.