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

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

由 Eric Palmer

FiercePharma: Pharma / 2018-02-23 23:33

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.

beiwei5du

halol plant整改了三年都没有符合FDA期望，导致大量新药品的上市延迟！！！

beiwei5du

Sun Pharma recalls over 17.5K bottles of nasal spray in U.S.

Pharma Manufacturing / 2018-02-23 23:21

Sun Pharmaceutical Industries, the U.S. arm of India’s Sun Pharma, is recalling over 17.5 thousand bottles of antihistamine nasal solution from the American market.

Per the FDA enforcement report for week of February 21, 2017 Sun is voluntarily recalling 17,554 bottles of Azelastine HCl Nasal Solution. The solution was manufactured at Sun's Halol facility, a key plant for the drugmaker. According to news reports, the U.S. FDA will soon begin a critical re-inspection  of the Halol manufacturing facility, after several reports of GMP issues. The Halol site, when fully operational, contributes as much as 15 percent of Sun Pharma's U.S. revenues.

The recent recall, a class III recall (not likely to cause adverse health consequences), is due to failure in meeting the relative standard deviation in a particular test during the 6-month long term stability test station.

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道路漫长黑暗

连Sun这种规模的企业都这么艰难，可见信任一旦失去了，再想建立真是困难重重。

beiwei5du

道路漫长黑暗 发表于 2018-2-25 17:39
连Sun这种规模的企业都这么艰难，可见信任一旦失去了，再想建立真是困难重重。

halol工厂占了SUN整个公司利润的几乎一半，3年前由于被发警告信，随后禁止了来自该工厂的任何新的产品注册申请。此后的多年对该halol工厂进行了多次的re-inspections,这次2月份(3个检察官，检查了12天）的检查，从乐观的层面看，其observations减少至3个，但是现阶段没有找到公开的该483发布。但是根据这篇文章Is Sun Pharma's Halol site close to a rebound?，这三个observations没有被定性（minor还是major)，其股市也回升了几个百分点（如果sun能clear halol plant from FDA的话，后期能预见的是会有销售和注册层面的迅速上升)，但是也有很多人现在持相对的观望状态：

Centrum Broking analyst Ranjit Kapadia said though the number of observations have come down to three from nine, it didn’t make any difference. “We still need details on these three observations. How serious they are before making any further comments. It is not known whether these observations are the same as earlier or new observations. The number of observations going down doesn’t matter.”

Purvi Shah, research analyst at Sharekhan said, “We view the development as a sentimentally positive read-thru for Sun Pharma and Sparc, as they have got only 3 observations as compared to earlier 9 observations in 2016-17 re-inspections. Closure of these observations with positive clearance from US FDA will remove long standing overhang on Sun Pharma and also for Sparc as it will help in acceleration of approvals from the plant. Currently, we have a ‘hold’ recommendation on the stock.”

选自US FDA flags issues at Sun Pharma’s Halol plant