India’s Sun Pharma Advanced Research Company Ltd (SPARC) has said the US Food and Drug Administration (FDA) has denied its application for approval to launch a new anti-epilepsy drug, citing manufacturing quality issues at its production site.
The company, the research arm of Sun Pharmaceutical Industries Ltd’s, India’s largest drugmaker, had received final approval from the FDA in March 2015 to sell the drug, Elepsia XR.
SPARC has since been “evaluating several marketing partners” to sell the drug, it said in a statement on Saturday.
The drug was to be manufactured at Sun Pharma’s Halol plant in Gujarat. The FDA inspected the plant last year and had outlined a number of concerns about manufacturing processes at the site.
The FDA said in a “Complete Response Letter” to SPARC “the compliance status of the manufacturing facility was not acceptable on the date of approval”, the company said.
Sun Pharma was working on resolving the issues the FDA raised and “has taken several corrective measures”, SPARC said.