COMPANY NEWS


Sun Pharma Advanced Research Company Ltd
BSE Code 532872 ISIN Demat INE232I01014 Book Value (₹) 10.22 NSE Symbol SPARC Div & Yield % 0 Market Cap ( Cr.) 7,014.53 P/E * 0 EPS * 0 Face Value (₹) 1
* Profit to Earning Ratio
* Earning Per Share
USFDA issues Complete Response Letter for PDP-716 of SPARC Back
(13 Jul 2023)
Sun Pharma Advanced Research Company today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for PDP-716 for the treatment of patients with Glaucoma, due to inspection findings at a third-party Active Pharmaceutical Ingredient (API) manufacturing facility.

The FDA did not raise any issues with the PDP-176 clinical efficacy or safety and no additional clinical data or trials have been requested. SPARC is committed to work closely with Visiox, the FDA and the third-party manufacturer to resubmit the NDA as quickly as possible.