After more than three years of effort and a couple of reinspections, India’s Sun Pharma has been unable to satisfy the the FDA's expectations for its key plant.
Sun Pharma, India’s largest generic drugmaker, said that at today’s conclusion of it the FDA’s latest reinspection of its Halol plant in Gujarat, India, it was presented with a Form 483 with three observations.
“The company is committed to addressing these observations promptly,” Sun said in the announcement (PDF), adding that it continues to work closely with the agency “to enhance its GMP compliance on an ongoing basis.”
While it only received three observations this time, Sun has been been at this remediation and reconciliation effort since September 2014 when the the FDA first noted issues at the Halol facility. While Sun has 40 manufacturing sites worldwide, Halol is the plant from which Sun launches most of its new products for the U.S., its largest market. But new launches were cut off when the FDA in 2015 vilified the plant in a warning letter.
A reinspection in late 2016 was unable to lift the stigma. That visit resulted in 10 observations, some of which the FDA noted were repeats.
The plant's problems have also stymied Sun’s efforts to expand beyond the deteriorating U.S. generics market into novel drug products. Last year, Sun received a second complete response letter for novel epilepsy drug Elepsia XR (levetiracetam) that it licensed from its drug development arm SPARC. It said the application was denied after an inspection of the Halol facility.
On top of the deteriorating pricing situation for U.S. generics, this has roiled India’s top generics producer. In its latest earnings report this month, Sun reported that its U.S. finished dosage sales were down 35% to $328 million from the same quarter a year ago.
Total revenue from operations fell 16% to about $1 billion, while net profit fell to to about $57 million from about $227 million a year earlier.