Sun says FDA again faults plant that is its key launch site for U.S. drugs

Halol manufacturing facility

https://www.fiercepharma.com/manufacturing/sun-says-fda-has-again-found-fault-plant-its-launch-site-for-u-s-drugs

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.

RELATED: Sun’s key plant in Halol again cited by FDA

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.

2 Responses

  1. With the head of the FDA being a venture capitalist I smell a low priced offer and takeover in the making, talk about corruption and insider trading and its being done with impunity not even trying to cover up, its right out in the open.

  2. I filed a formal grievance with the Teva manufacturing plant in New Jersey, I asked them if they had Altered, Reconfigured, Added-Subtracted, or in any way manipulated BARRs generic ADHD medications; they LIED. I saw online a year later- that they admitted it, adding that “You can’t Sue Us” Also, Teva was sued by another big pharma for millions for breaking a patent agreement, yet those of us who are damaged by the synthetic Arsenic we’re never notified or compensated. It was Shire pharma who received full compensation. With all the secret surveillance in our homes, wiretapping, and 24/7 real time stalking, who stands a chance ? Not to mention the Ability to distort, manipulate data. It’s a virtual set-up, framing, special-effects, and other Hi-Tech military abilities. I’m near death as it is, and I can’t live in a world of 24/7 Torture,. I want this OVER.

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