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

Telangana: Granules India has announced that the US Food and Drug Administration (US FDA) has issued a Warning Letter to the ...

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

HYDERABAD: In a major setback to Hyderabad-based pharma player Granules India Ltd, the US Food and Drug Administration (USFDA ...

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

Hyderabad: In a major setback for Hyderabad-based pharma player Granules India Ltd, the US Food and Drug Administration ...

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

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

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

Mojdeh Poul; President & Chief Executive Officer; Integra Lifesciences Holdings Corp Lea Knight; Chief Financial Officer, Executive Vice President, Principal Financial Officer; Integra Lifesciences ...

Q4 2024 Earnings Conference Call February 27, 2025 8:30 AM ETCompany ParticipantsBill Szablewski - Head of Capital ...