Sun Pharma down in the red

Sun Pharma and its subsidiary, Sun Pharma Advanced Research Company (SPARC) are amongst the top losers on the BSE. Sun Pharma is down almost 3.5% at Rs.862.25 with an intra day low of Rs.857.50 and SPARC is down 2.5% at Rs.376.65 with an intra day low of Rs.368.50.

The stocks are down as news came in that the US FDA has issued a complete response letter (CRL) to the company's new drug application (NDA) for Elepsia XR (Levetiracetam extended-release tablets 1000 mg and 1500 mg).  The company had earlier received a final approval from USFDA in March 2015 for this product and was evaluating several marketing partners for commercialization.

And what we see now is that for the very same drug application, it has now received a CRL from the USFDA rescinding its earlier approval, citing that the compliance status of the manufacturing facility was not acceptable on the date of approval.

Elepsia XR is to be manufactured at Sun Pharma’s Halol facility and the company has said that it is working with USFDA in resolving the cGMP deviations at the facility and has taken several corrective measures.