Torrent Pharma's Dahej unit gets five US FDA observations

Observations are related to two products awaiting approvals

The US drug regulator has issued five observations related to two products from Torrent Pharmaceuticals’ Dahej plant that are awaiting approvals. A company spokesperson confirmed the development and said they would send a reply to the US Food and Drug Administration (US FDA) within the stipulated time. Analysts say there would be no immediate impact on Torrent as these products were not to be launched immediately. 

US FDA officials visited the plant between June 26 and June 30 and issued observations related to discrepancies on batch distribution, written procedures, maintenance of equipment and criteria for sampling and testing, etc.  Analysts noted that if the company’s response related to remedial actions is satisfactory, the issue would not be escalated further. After being down on Tuesday morning, Torrent Pharma stocks ended the day’s trade on BSE up by 2.5 per cent to Rs 1,328.40 a share. Torrent’s Dahej plant is a relatively new plant that received the establishment inspection report from US FDA in March 2016. The plant, which had earlier received approval from EU Germany, was set up mainly to cater to the regulated international markets like the US, Brazil and Germany, etc.

The plant is spread across 70 acres with a built-up area of 97,000 sq m. The first phase has an installed capacity of around 7,500 million tablets and capsules and 25 tonnes of active pharmaceutical ingredients (API) per annum. Once the second phase is commissioned, the total capacity will increase to about 14,000 million tablets and capsules and 80 tonnes of API per year. In May, the US FDA had issued a Form 483 making four observations on the company’s manufacturing facility in Indrad, Gujarat.