FDA Revokes Approval for Sun Pharma Drug Over GMP Issues

Sept. 30, 2015

The U.S. FDA has revoked an approval granted in March to India’s Sun Pharma Advanced Research Company (SPARC) to launch a drug for seizures, citing manufacturing quality issues.

Elepsia XR was the first FDA-approved drug for SPARC, the research arm for India's biggest drugmaker.

SPARC had planned to produce the drug at Sun Pharma's Halol plant, in the western Indian state of Gujarat.  The FDA had outlined issues at the Halol production site last year, as well as warning the same plant for being lax in monitoring the follow-up corrective actions for the drugs it recalled from the U.S. market.  

Sun was said to be working on correcting these problems, but the FDA response letter states that, "the compliance status of the manufacturing facility was not acceptable on the date of approval."

Read the Reuters press release