NEW DELHI: Sun Pharma Advanced Research Company (SPARC) expects further delay in start of royalty income from its two new drug applications, including an eye drop, due to its parent Sun Pharma receiving a warning letter from the US health regulator for its Halol plant.
The company’s two new drug applications (NDAs), Xelpros and Elepsia XR, are to be manufactured at Sun Pharma’s Halol plant, which has recently received a warning letter from the US food and Drug Administration (USFDA).
“Consequent to above development, the management expects a possible further delay in the projected royalty income for the company from the above mentioned products,” Sun Pharma Advanced Research Company (SPARC) said in a regulatory filing.
The company’s management is closely monitoring the development and has initiated steps to mitigate the possible adverse impact on the company, it added.
SPARC has already received a complete response letter (CRL) from the USFDA for the two new products. A CRL is a communication from the USFDA that informs companies that an application cannot be approved in its present form.
Sun Pharma Advanced Research Company was demerged from Sun Pharma as a pharma research and drug discovery company in 2007.