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S&P
BSE SENSEX
73,828.65
-510.79
-0.69 %
Corporate Announcement
Security Code
532872
Company
SUN PHARMA ADVANCED RESEARCH COMPANY LTD.
Exchange Received Time
19/05/2017 19:02:45
Exchange Disseminated Time
19/05/2017 19:02:51
Time Taken
00:00:06
Updates |
5/19/2017 7:02:46 PM
This is to inform you that, the Company has received a Complete Response Letter (CRL) from the USFDA for its New Drug Application (NDA) for Elepsia XRTM, Levetiracetam extended-release tablets 1000 mg and 1500 mg. The CRL references the recent inspection of the Sun Pharmaceutical Industries Ltd.( SPIL)'s Halol manufacturing site by USFDA and indicates that, satisfactory resolution of the deficiencies identified during the inspection is required before the final approval of Elepsia XRTM can be granted. SPARC had out-licensed Elepsia XRTM to a subsidiary of Sun Pharmaceutical Industries Ltd in July 2016. As informed to the Company, SPIL is working with USFDA for resolving the cGMP deviations at the Halol facility and has taken several corrective measures.
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