The US FDA has issued an Establishment Inspection Report (EIR) to Granules Pharmaceuticals, Inc., a wholly-owned foreign subsidiary of Granules India. The inspection was a Pre-Approval Inspection (PAI) conducted in June 2025 at the facility in Chantilly, Virginia, USA, for a first-to-file controlled substance ANDA. The company states that one observation was made during the inspection, and it has been resolved.
US FDA Inspection Update
Granules Pharmaceuticals, Inc., a US-based subsidiary of Granules India, has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (FDA). The report follows a Pre-Approval Inspection (PAI) that took place in June 2025.
Details of the Inspection
The FDA inspection was conducted at the Granules Pharmaceuticals facility located in Chantilly, Virginia, USA. This inspection was specifically related to a first-to-file controlled substance Abbreviated New Drug Application (ANDA). According to the company’s statement, there was a single observation made by the FDA inspectors during the course of the PAI. Granules India has confirmed that this observation has already been addressed and resolved.
Source: BSE
