USFDA concludes audit at Indoco's Goa Plant I
Source: IRIS | 28 Jan, 2019, 01.49PM
The US Food and Drug Administration (USFDA) audit, which started on January 17, 2019 at Indoco's Goa Plant I (Oral Dosages Facility), concluded on January 25, 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, 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 the company gained Rs 2.15, or 1.18%, to trade at Rs 184.15. The total volume of shares traded was 13,459 at the BSE (11.08 a.m., Monday).