The company disclosed the development in an exchange filing under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
According to the filing, the CRL was issued due to inspection findings at the finished product manufacturing facility. The USFDA did not raise any other issues with the PDP-716 NDA, the company said.
A Complete Response Letter is issued by the USFDA when the regulator determines that it cannot approve a drug application in its present form and requires additional information or corrective action from the applicant.
Ocuvex Therapeutics is the licensing partner for PDP-716, a drug candidate for which the NDA had been submitted to the USFDA for review.
Sun Pharma ARC informed stock exchanges that the information was being submitted for dissemination and investor information purposes.
The company did not disclose additional timelines or further regulatory steps related to the application in the filing.
The regulatory update comes amid continued focus on inspection compliance and manufacturing standards for pharmaceutical products seeking approval in the United States market.
Shares of SPARC, the stock symbol of Sun Pharma Advanced Research Company Ltd, were trading at ₹179.70 or 10.82%.
