| Exchange Received Time  10/07/2017 11:50:29 Exchange Disseminated Time 10/07/2017 11:50:35 Time Taken 00:00:06|
|Sub:USFDA to Lift Import Alert 99-32 on the company's Unit-II at Visakhapatnam.|
Divi's Laboratories has been informed by the US-FDA that it will lift the Import Alert 99-32 imposed on the company's Unit-II at Visakhapatnam.
We had earlier informed the Stock Exchanges that the US-FDA has issued an Import Alert under clauses 99-32 and 66-40 in March of 2017 and a warning letter in May of 2017 for our Vishakhapatnam facility. Divi's Laboratories has filed a detailed responses and given updates to the Form-483 and the warning letter within the stipulated time. Divi's Laboratories, along with its external consultants, specialists and subject matter experts, has taken up appropriate remediation measures to address the concerns raised by US-FDA. The company awaits further action from US-FDA in this regard.
The above development illustrates our commitment to work closely with the US-FDA and our efforts towards compliance to cGMP regulations.