Any update on the FDA audit?
Officially it may come after 3.30PM
Unit-2 has been inspected by US-FDA from September 11 to September 19, 2017.
This inspection was for full cGMP and verification of all Corrective Actions proposed against the previous Inspection observations. Divi’s Laboratories Limited announces that all previous observations have been confirmed as completed and resolved.
On completion of this inspection, Divi’s Laboratories Limited has received a Form 483 citing six observations which are procedural and the company will be responding to these within the stipulated time.
I am new to pharma companies investing. I hold Laurus labs, they also finished USFDA and WHO audits on 15th. But my question why Laurus labs stock price not reacts and DIVIS labs react to inspections. Is there specific things we need to dig inside. As companies publish audit is finished.
Disc: Invested in Laurus labs so I am interested in how this USFDA inspection things work.
Divis lab share price was around 1100-1200 when it got FDA observations and fell to 700+. After Import alert, it fell to 600+
few months back when FDA removed few observations rose to 760+ and then fell to 630+. Now market feels like 1100+ is price it should be so its increasing day by day.
Disc: not invested in Divis now. Sold it when it reached 730+
Divi’s Laboratories has been informed by the US-FDA that it will be lifting the Import Alert 66-40 and moving to close out the Warning letter issued to the company’s Unit-II at Visakhapatnam.
The management was quite swift in getting the re-inspection done and making sure that import alert is lifted. I think all this happened in span of 6 months which is quite commendable if you look at other pharma companies who are facing USFDA issues.
Divi’s received EIR from US FDA for unit II. indeed its a commendable job by the management in resolving the issue swiftly.
"We had earlier informed the Exchanges that the company’s Unit-II at Visakhapatnam was inspected by US-FDA in September, 2017 wherein a Form-483 was issued with 6 observations.
In this regard, we wish to inform you that we have now received an Establishment Inspection Report (EIR) from US-FDA for our Unit-II, as closure of audit by FDA."
This worked quite well. Hopefully in a quarter or 2 results would be much better.