Sun's Halol audit may be a routine exercise: Expert

Written By Unknown on Kamis, 11 September 2014 | 21.03

The US drug regulator is conducting audits at Sun Pharma's Halol facility in Gujarat. Sun had recalled multiple products made in this facility. Could this spell further trouble for Sun Pharma? Pharma Asia News India bureau chief Vikas Dandekar spoke with CNBC-TV18's Senthil Chengalvarayan and Sonia Shenoy to discuss the development.

Also read: Sun Pharma down 6% on surprise audit by USFDA at Halol unit

Below is the edited transcript of the interview on CNBC-TV18.

Sonia: This audit I understand was expected this year. Then why the surprise and why the market reaction?

A: In the last couple of months there have been recalls and these recalls probably led the FDA to think about a more intensive audit and after what happened at Sun's Karkhadi plant, which was served an import alert, they [FDA] had mentioned at that time that Sun may have to do a global review of its manufacturing facilities.

So, this has to do with probably a progression of that effort from FDA. Again it relates to a lot of quality processes, whether we have identified the root cause analysis, whether those kind of G&P standards are still being maintained by Indian companies. So, it is probably more incremental in nature and I think that is where everything is leading into on whether the Indian companies are actually following all the standards that are to be complied according to the FDA guidelines.

Sonia: Since the Halol facility is the most important for Sun Pharma what do you think the outcome could be and if it is the worst case scenario then what could the impact be?

A: As of present we cannot conclude that things are going to go in a negative direction because the inspection is still going on and until and unless we have an inspectional observation in Form 483 we can't jump the gun. So, we would assume that the facilities are upgraded and up to date for expected inspection because Halol was under the scanner.

Lots of analysts had expected that FDA inspectors will be coming and doing some investigations and this time it looks like it is fairly intensive. So, assuming that things do go well, things will get corrected.

Senthil: It is a very important plant for them. It accounts for a very large percentage of their sales to US. So, you would assume that the management would have been very careful there?

A: We would have to be and more so because it is Sun Pharma. They have just two markets broadly to bank on, US and India. If they are not doing what is needed to salvage that situation it will probably be a very grave danger for their topline. Sun Pharma as you know it is about USD 30-35 billion, well above rest of the pack. So, a lot rests on their shoulders.

Senthil: In some ways I am getting the sense that you are calling this a necessary but routine inspection?

A: It will be a routine inspection more or less unless we see some sparks flying that some inspectional observations – one thing that I can say that FDA is under pressure from the US government and from lot of politicians in the US.

We had just a couple of days ago a lot of fire related to Nexium because of the approvals getting delayed and the same kind of things which Ranbaxy has faced with Valsartan and Lipitor before that.

So, FDA is not in a great sweet spot that we will delay the applications and that is why generic drug user fee application has also come into picture where you pay for the inspections and it is fast-tracked, your approvals come faster.

Senthil: Which is a positive in a sense for Sun?

A: Yes, absolutely.


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