Brief: Sun Pharma Advanced Research Says FDA Issues Complete Response Letter For Pdp-716 NDA

Sun Pharma Advanced Research

13/07/2023 15:27

July 13 (Reuters) - Sun Pharma Advanced Research Co Ltd  SPRC.NS :
    * FDA ISSUES COMPLETE RESPONSE LETTER FOR PDP-716 NDA DUE TO INSPECTION
FINDINGS
AT 3RD-PARTY API MANUFACTURING FACILITY
    * NO ISSUES WITH CLINICAL EFFICACY OR SAFETY WERE IDENTIFIED IN CRL
    * NO ADDITIONAL CLINICAL DATA OR TRIALS HAVE BEEN REQUESTED


Further company coverage:  SPRC.NS 

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