US FDA gives EIR to Torrent Pharma's Dahej plant

Torrent Pharmaceuticals has successfully obtained the establishment inspection report (EIR) from US FDA for its plant located at Dahej SEZ in Gujarat. Dahej plant, which earlier received approval from EU Germany, was set up to cater mainly to the regulated international markets like US, Brazil, Germany etc.
 
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 MT of active pharmaceutical ingredients (API) per annum. Construction of phase II is expected to start soon. Once commissioned, the total capacity will increase to about 14,000 million tablets & capsules and 80 MT of API per year.
   
With the latest US FDA approval, Dahej facility is the third plant of Torrent to receive US FDA approval out of its five manufacturing units. The company’s other US FDA approved plants include Indrad (Gujarat) and Pithampur (Madhya Pradesh).