Gujarat-based Torrent Pharmaceuticals today informed that its Dahej plant has received the establishment inspection report (EIR) from USFDA. Prior to this approval, the plant has also received approval from EU Germany. It was set up to cater mainly to the regulated international markets like US, Brazil, Germany etc.
It is the third plant of Torrent to receive USFDA approval out of its five manufacturing units. The other two USFDA approved plants are in Indrad, Gujarat and Pithampur, Madhya Pradesh.
The Dahej plant is spread across 70 acres with a built-up area of around 97,000 square meters. The phase I has an installed capacity of around 7,500 million tablets, capsules and 25 tonnes of active pharmaceutical ingredients (API) per year. Construction of phase II would start soon and it would take the capacity up to 14,000 million tablets and 80 tonne of API per year.