Manufacturing issues result in another blow to Sun Pharma from FDA

Continued problems at Sun Pharmaceutical's Halol facility in India sparked the U.S. Food and Drug Administration to pull its approval for the company's research arm to launch a drug for seizures.

The regulatory agency's move over the weekend was based on manufacturing quality issues at the Halol plant in Gujarat, Reuters reported. The FDA began to express concerns about the facility more than a year ago. In March, the agency gave its approval to Sun Pharma Advanced Research Company (SPARC) to produce Elepsia XR, which is used to help treat partial-onset seizures in epilepsy patients aged 12 or older.

It was the first SPARC drug to get FDA approval. In a statement issued Friday, SPARC said the agency had issued a "Complete Response Letter" that said "the compliance status of the manufacturing facility was not acceptable on the date of approval."

Earlier this month, Sun Pharma issued a voluntary recall of three lots of bupropion hydrochloride extended-release tablets manufactured at the Halol plant because they failed dissolution testing.

That recall came on the heels of a 4% slide in U.S. sales for the company for its last quarter, which Sun Pharma said was mostly due to "temporary supply constraints arising from remediation efforts at the Halol facility."

That remediation began after the FDA issued a Form 483 to the plant upon completion of an inspection there a year ago, and the supply constraints can be tracked in part to the recalls the Indian drugmaker has had to make of meds made at the facility.

The Financial Times recently reported that 39 pharmaceutical manufacturing plants in India owned by 27 companies were banned from exporting drugs to the U.S.

- check out the Reuters story
- see the SPARC statement (PDF)

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