Torrent Pharmaceuticals Ltd (TPL), on Friday, said it has obtained the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its plant located at Dahej SEZ in Gujarat.
Prior to this approval, the plant had also received approval from EU, Germany. It was set up to cater mainly to the regulated international markets such as US, Brazil, Germany and others, the company said in a statement here.
With this, TPL’s Dahej plant has become the third plant of the company, out of five, to receive the USFDA approval. The company’s other USFDA approved plants include those at Indrad in Gujarat and at Pithampur, near Indore.
The Dahej plant is spread across 70 acres with a built up area of around 97,000 sq. m. Its phase I has an installed capacity of about 7,500 million tablets/capsules and 25 mt of API per annum. Construction of phase II will commence soon and, on completion, its total capacity will increase to about 14,000 million tablets/capsules and 80 mt API per year.