Torrent Pharma claims that the US FDA issues an “EIR” for the company’s manufacturing facility

Torrent Pharmaceuticals said Thursday that the U.S. Food and Drug Administration (FDA) issued a Factory Inspection Report (“EIR”) for the company’s manufacturing facility in Dahej,
Gujarat.
EIR stands for inspection fence.

The inspection was completed by the US FDA. Previously, in March 2019, the Dahej plant underwent an official Indicated Action (OAI) procedure by the US FDA.
The drug regulator inspected the factory again this May, May 17-25, and issued a 483 form with two comments, the company said in a statement.

The website’s updated notice reads VAI (Voluntary Action Indicated), indicating that the torrent is accepted for the broadcast ANDAS.
“This will further enhance the company’s prospects and fuel growth in the US market with a new product offering.”

The Dahej facility produces APIs and compounds for Torrent Pharma’s international markets.

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