The USFDA issued a warning letter to Granules India Ltd's Gagillapur facility after an August 2024 inspection highlighted ...

The development may temporarily delay the approval of pending product submissions from the site, but existing manufacturing ...

Drug firm Granules India Ltd on Thursday (February 27) announced that the US FDA has issued a Warning Letter for its ...

Granules India's shares fell nearly 8% after the US FDA issued a warning letter regarding its Gagillapur facility, citing ...

"On February 26, 2025, the US FDA issued a Warning Letter to Granules' Gagillapur facility based on its inspection conducted ...

Granules India's Gagillapur facility receives FDA warning letter, impacting product submissions review until resolved, company remains confident in resolution.

From turning away inspectors to falsifying data and leaving "bare footprints" in production containers, two of the latest ...

Granules added that manufacturing and distribution of its existing products at the facility will continue unaffected.

James Jones resigned as FDA deputy commissioner and said the Trump administration's "indiscriminate" job cuts show "disdain for the very people necessary to implement your agenda." ...

The reversal is the latest example of President Donald Trump and billionaire Elon Musk’s chaotic approach to cost-cutting, ...

The Warning Letter is dated February 26, 2025 and the facility continues to hold an "Official Action Indicated" (OAI) status.

The most significant near-term challenge is the FDA warning letter received in December 2024 and the import alert affecting Viatris’ Indore facility, which management estimates will reduce 2025 ...