The US Food and Drug Administration (USFDA)conducted audit at Indoco's sterile manufacturing facility in Verna, Goa (Plant II) from 27th May'19 to 4th June'19, issuing 4 observations (483s). These observations are procedural in nature, not pertaining to data integrity. The Company will submit its responses shortly.
Commenting on this development, Ms. Aditi Kare Panandikar, Managing Director - Indoco Remedies Ltd. stated, "The recent USFDA inspection was a scheduled PAl, i.e., Prior Approval Inspection for Injectable products, filed from this facility. We are hopeful for an early and successful closure of this audit, which will expedite approvals of the pending ANDAs."
Shares of INDOCO REMEDIES LTD. was last trading in BSE at Rs.179.5 as compared to the previous close of Rs. 182.95. The total number of shares traded during the day was 2274 in over 157 trades.
The stock hit an intraday high of Rs. 183 and intraday low of 178.5. The net turnover during the day was Rs. 411056.