The Sun unit announced its receipt of a complete response letter (CRL) in a Bombay Stock Exchange (BSE) filing last week.
The firm explained that “satisfactory resolution of the deficiencies identified during the inspection is required before the final approval of Elepsia XRTM can be granted.”
Sun has been working to address problems at the Halol site – where the active pharmaceutical ingredient (API) for Elepsia is made – since 2014 when a US Food and Drug Administration (FDA) team found a number of shortcomings.
Initially, Sun appeared to make some progress, winning US FDA approval for Elepsia in March 2015.
A subsequent inspection of the facility in November and December last year earned Sun a second Form 483 detailing nine new problems.
Elepsiahad been earmarked for launch in the US in the second half of 2016 according to a business update in Jul7 2015. The drug was the first SPARC drug approved by the US Food and Drug Administration (FDA).