India's Sun Pharma research arm sees FDA nod for Elepsia XR yanked by FDA on manufacturing

Sun Pharma managing director Dilip Shanghvi

The research arm of Sun Pharmaceutical Industries has seen its license for epilepsy drug Elepsia XR revoked by the U.S. FDA because of manufacturing violations at its production site, dealing a blow to its aims of moving beyond generics.

The Sun Pharma Advanced Research Company (SPARC) had planned to launch the drug in the second half of this year, it said in June. Reuters said that Elepsia XR was its first to receive an FDA approval.

In the same month, the research unit licensed Xelpros eye drops to Sun Pharmaceutical Industries for an upfront payment of $3 million and potential milestone payments of $16 million, showcasing the potential of in-house research which lags at most Indian firms.

"SPARC had earlier received a final approval from USFDA in March 2015 for this product and was evaluating several marketing partners for commercialization," the company said in a statement on its website. "However SPARC has now received a CRL (complete response letter) from the USFDA rescinding its earlier approval, citing that the compliance status of the manufacturing facility was not acceptable on the date of approval."

The drug was slated to be made at Sun Pharmaceutical's Halol facility, one of a number of the company's plants under careful scrutiny by the FDA.

Last month, the Financial Times said 39 plants in India owned by 27 companies were banned from exporting to the U.S.

Reuters also said that the company had worked "very aggressively" to find partners for the product and was in "some advanced discussions" to launch by the second half of fiscal 2016, adding that analysts estimated modest sales of about $50 million annually.

- here's the Reuters story carried in Business Today
- and the SPARC release (PDF)