USFDA Gives Torrent Pharma’s Indrad Facility A Thumbs Up With VAI Classification
Torrent Pharma’s Indrad facility receives FDA’s VAI classification, allowing continued operations and improvements.
Breaking News
Aug 30, 2024
Mrudula Kulkarni
Torrent Pharmaceuticals has announced that the US Food and
Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR)
for its Indrad facility in Gujarat, following an inspection conducted from June
3 to June 12, 2024. The facility received a "Voluntary Action
Indicated" (VAI) classification, indicating that while some observations
were made, the company can continue its operations.
This announcement follows Torrent Pharma's earlier
notification about the start of the inspection. With the issuance of the EIR,
the USFDA has officially closed the inspection process. The VAI status allows
Torrent to maintain its manufacturing activities while working on the noted
observations. This outcome is a significant achievement for Torrent
Pharmaceuticals, as it reinforces the company’s standing in highly regulated
markets like the United States, where adherence to strict regulatory standards
is vital for gaining product approvals.
Torrent Pharma remains focused on maintaining top-tier
manufacturing standards and addressing any areas for improvement to enhance its
operational performance. The successful closure of this inspection is likely to
boost investor confidence and open doors for new growth opportunities in the
pharmaceutical industry.