USFDA concludes audit at Indoco's Goa Plant I with 6 observations

Posted On: 2019-01-28 10:21:51

The US Food and Drug Administration (USFDA) audit, which started on 17th January, 2019 at Indoco's Goa Plant I (Oral Dosages Facility), concluded on 25th January, 2019 with the Regulatory Agency issuing 6 observations (483s) to the site. None of these observations are critical in nature. The Company will respond to these observations within the stipulated time of 15 days.

Aditi Kare Panandikar, Managing Director, Indoco Remedies Limited commented, "Most of these observations are related to areas of improvement needed in documentation and review procedures. These observations / recommendations will help us further improve our quality systems in the plant, which in turn, will give a boost to revenues from the US market".

The site will continue to supply to US market, the existing approved product and await approval of pending ANDAs.

Shares of INDOCO REMEDIES LTD. was last trading in BSE at Rs.182.6 as compared to the previous close of Rs. 202.3. The total number of shares traded during the day was 9042 in over 426 trades.

The stock hit an intraday high of Rs. 206.15 and intraday low of 180. The net turnover during the day was Rs. 1703776.

Source: Equity Bulls