Lupin share price hit fresh 52-week low of Rs 1,335.30 on Thursday, down 2.6 percent intraday after the US health regulator issued Form 483 with three observations to its Goa plant.
The US Food and Drug Administration inspected this plant between March 27 and April 7, 2017.
The observations as per news reports are 1) failure to review any unexplained discrepancy; 2) no written procedures for production and process controls; and 3) control procedures that monitor output of manufacturing processes not established.
Prima facie, these observations seem procedural and are related to standard operating procedure (SOP), Antique said quoting the company.
The brokerage house further said it is surprised by these kinds of observations given that this is the third inspection in less than two years and the FDA had pointed out SOP-related issues in the previous inspections.
Antique feels at this stage the chances of an escalation seem to be unlikely as the company had recently received final approval from USFDA for anti-depressive Wellbutrin XL (that was filed from Goa plant) on April 8, just after the inspection was completed.
In the past, Goa unit was inspected in July 2015 and February 2016. The July 2015's Form 483 was cleared in July 2016 and the latter in November 2016.
Goa plant contributed close to 50 percent of the US sales (around 25 percent of consolidated revenue) and accounted for 30 outstanding ANDAs, according to the brokerage house.
At 15:08 hours IST, the stock was quoting at Rs 1,336.95, down Rs 34.30, or 2.50 percent on the BSE.Posted by Sunil Shankar Matkar