Granules India gains key FDA approval for Unit V facility, marking major compliance milestone

Granules India gains key FDA approval for Unit V facility, marking major compliance milestone

Hyderabad-based Granules India Limited has achieved a significant regulatory milestone, securing an Establishment Inspection Report (EIR) with a “No Action Indicated” (NAI) status from the U.S. Food and Drug Administration (FDA) for its Unit V facility in Jawaharlal Nehru Pharma City, Andhra Pradesh. The pharmaceutical firm received the EIR following a comprehensive inspection held in […]

Granules India faces six observations after US FDA inspection at Gagillapur facility in Hyderabad

Granules India faces six observations after US FDA inspection at Gagillapur facility in Hyderabad

Granules India Limited has recently completed a US Food and Drug Administration (US FDA) inspection at its Gagillapur facility in Hyderabad, Telangana, resulting in six observations. This development comes at a crucial time for the pharmaceutical giant, which has been expanding its global footprint and ramping up its manufacturing capabilities to cater to the growing […]