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  #1  
Old 03-23-2008, 10:33 PM
Anonymous
 
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Banghead Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Major Fraud unearthed by USFDA at Ranbaxy Bata Mandi plant

In a major blow to Ranbaxy , the officer of criminal investigations of US FDA , Mr Jose Hernandez unearthed a serious fraud at the new Bata Mandi facility near Paonta Sahib.During the first day of the Pre Approval Inspection conduted on March 3rd , the investigator found that the Equipment validation was completed prior to even receipt of the granulation equipment used for Tacrolimus capsule exhibit batches .There were no human resources at the site for last full year whereas the chief of technical operations Mr Ramesh Parekh showed that many people were actually working at the new site .The investigation will be completed on 7th March 2008 .The inspector has taken interviews of key technical staff to record their versions so that criminal investigations can be proven.

The name of people who were shown as part of the R and D / manufacturing had no records to prove that they actually had taken trial batches .This will become another case like Able labs in USA which had to shut down after the frauds were found .

US FDA had again raided the US facilities and offices again in end of 2007 to find discrepancies .Actually the Ranbaxy guys are too smart and they have been managing the inspections over a long time now but this will not continue for long .For info to some , I am a freelance journalist and has no relationship with Ranbaxy .The only objective is to bring out the truth .
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  #2  
Old 03-24-2008, 08:34 AM
Anonymous
 
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Banghead Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

It has become a way of working at Ranbaxy with all the fudging and manipulation of data in QC, Mfg and development areas .Even the top gives green signal to manipulate , thats worst and there is no concrete plans to improve .Thats what the industry is watching , what change they will bring to imrove such things .P Sahib plant is already under investigation and now batamandi plant here has boomed even before take off .This is a setback .These guys never improve .It needs to do with high level politics and bad culture and attitude is difficult to change .
Dewas plant was bad anyway from the beginning as it is the mother plant where all thees seeds of politics are sown by so call leadership.....
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  #3  
Old 03-24-2008, 12:40 PM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Last year, two of India's largest and most respected drugmakers, Ranbaxy Laboratories and Wockhardt, received FDA warning letters about quality-control and documentation issues at their Indian plants. Both companies were told that if they did not improve, some of their Indian-made products would be barred from the United States.

In February, the FDA's Office of Criminal Investigations raided the New Jersey offices of Ranbaxy. The FDA would not comment on the raid, and the company has said it is cooperating with the agency. A company spokesman said that the FDA was conducting "a wide dragnet," and a source familiar with the investigation said that it involved an unusually large number of investigators which is rare.It seems Ranbaxy is in for a big trouble ahead .Working with Parexel consultants has only made the situation comples rather than doing anything good for the co.

Many people have left due to surmounting and endless issues related to quality including giving affidavits by its senior person exiting to US FDA that they dont have anything connected with Ranbaxy after their exit .One of the person is the ex Head of R and D team at Gurgaon.
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  #4  
Old 04-03-2008, 08:41 AM
Anonymous
 
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Thumbs down Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

If insiders are to be believed , Bata mandi plant which received many critical 483s including data integrity and personal integrity issues may not get the approval from Us FDA as the parent site of Paonta Sahib is under investigation and clearance has not been given to this site for any further product approvals .

Batamandi site is dependant on the main PS site for QC , warehousing etc apart from other support functions .This will jeopardise the chances of getting the approvals .

The management is still not serious of the mistakes and the serious frauds .Lots of complaints have also been sent recently by employees to FDA .That shows lots of enimity with the company which is surprising .But company has to bear the brunt now as there is no or poor leadership .

Leadership crisis cud hit Ranbaxy...
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  #5  
Old 04-06-2008, 02:22 AM
Anonymous
 
Posts: n/a
Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

The initial blog of this same thread was blocked by cafepharma which had lot of truth .Anyway Ranbaxy cannot hide the facts from people for long .Hiring consultants can only make the pocket fat for consultants .Ranbaxy has hired the GMP consultants for many years for now but it does not resolve any issues .A major change in attitude and thinking process is the need of the hour .You see QA head , Regulatory head , Manufacturing head .They are all crooks and have managed big positions by wrong means , be it politics , threat, cooersion, boss pleasing , extra curricular ( you know what i mean ) .It has led to only one thing ...deterioration in the standards for what Ranbaxy was known in the past .No good talent is getting attracted these days .Even to taht extent that they are not able to get teh QA head for long now .
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  #6  
Old 04-06-2008, 01:24 PM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Look disgruntled employee, we get it. The company screwed you over, so you are using the interenet as a means of getting revenge. Stop reposting the same nonsense. People are bored with you and your fake news.
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  #7  
Old 04-06-2008, 05:35 PM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Yes, don't you know that this forum is only for people to post raves, heap praise and offer exaltation to their pharma employers, benefactors and masters?
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  #8  
Old 04-06-2008, 09:42 PM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Quote:
Originally Posted by Anonymous View Post
Yes, don't you know that this forum is only for people to post raves, heap praise and offer exaltation to their pharma employers, benefactors and masters?
Point taken. I'll shut up now.
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  #9  
Old 04-25-2008, 05:56 AM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

hi
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  #10  
Old 04-26-2008, 01:43 AM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Can anybody inform what is the latest status of Ranbaxy's Paonta Sahib and Bata Mandi plant approval from FDA? Is their Dewas plant is also in trouble?
There is a strong rumour also that Ranbaxy is actively looking for a new Regulatory head and QA head.
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  #11  
Old 05-01-2008, 01:45 PM
Anonymous
 
Posts: n/a
Arms Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

All this is nonsense, I think first you should peep into yourself, before blaming others. This is obvious that no system is fool proof, hence there may be loopholes in the system but you can't blame the entire organization for it. The 483s shall be responded as per the norms and ranbaxy will standout ever shining as it was a few years back. Wait and see the result of hard and intelligent efforts put together. Dogs keep barking.........Elephants keep marching.

Best of blogging enjoy
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  #12  
Old 05-01-2008, 05:34 PM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Quote:
Originally Posted by Anonymous View Post
All this is nonsense, I think first you should peep into yourself, before blaming others. This is obvious that no system is fool proof, hence there may be loopholes in the system but you can't blame the entire organization for it. The 483s shall be responded as per the norms and ranbaxy will standout ever shining as it was a few years back. Wait and see the result of hard and intelligent efforts put together. Dogs keep barking.........Elephants keep marching.

Best of blogging enjoy
Do you realise that the company has NOT RESOLVED previous 483 issues related to Paonta Sahib FOR TWO YEARS NOW? And now the facilities at Bata Mandi and Dewas are under the scanner. I suppose the company is shining so much that you are completely blinded by the glare!
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  #13  
Old 05-25-2008, 04:30 AM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Hi
What is happening to Ranbaxy now a days?I am told recently a marketing fellow has become head of all things technical - Manufacturing,QA and Supply Chain.Ranbaxy has drifted from "research based" long ago and with supply agreement with Orchid in place, has become a marketing company.Dr Parvinder Singh must be turning in his grave now.
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  #14  
Old 05-27-2008, 10:53 PM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

You are right, Ranbaxy became a marketing company overnight with one Orchid Agreement. Are you kidding me? the company still has 8 manufacturing facilities around the world. Since when does aligning yourself with a strong competitor make you a marketing company?
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  #15  
Old 05-28-2008, 11:53 AM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Quote:
Originally Posted by Anonymous View Post
You are right, Ranbaxy became a marketing company overnight with one Orchid Agreement. Are you kidding me? the company still has 8 manufacturing facilities around the world. Since when does aligning yourself with a strong competitor make you a marketing company?
Since when, you ask? Well, since 3 of those 8 manufacturing facilities went down the toilet because they failed FDA inspections. And since the facility in Romania lost its lustre.
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  #16  
Old 06-09-2008, 03:01 AM
Anonymous
 
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Default Re: Ranbaxy will bounce back

I saw a lot of things bad written about Ranbaxy. Actually it's fall was scripted by some idiot R&D guys especially NDDS group who couldn't deliver waht they promiosed to the management. they have all run away and remain ones are running for cover. Big money was spent on NDDS.
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  #17  
Old 07-02-2008, 11:02 AM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

If all is nonsense then read the story in eco times india and many international dailies:

NEW DELHI: Two manufacturing facilities of Ranbaxy Laboratories are learnt to have come under the scanner of the US Food and Drug Administration (USFDA), the drug regulatory body in the US.

All pharma companies have to get USFDA approval for selling medicines in the US. This is in addition to the company’s Paonta Sahib (Himachal Pradesh) plant, which has been the subject of USFDA investigations for the past two years.

According to sources, USFDA carried out inspections at Ranbaxy’s manufacturing plant at Dewas (Madhya Pradesh) and Batamandi (Himachal Pradesh) earlier this year. USFDA is learnt to have raised concerns over cross contamination at the Dewas plant.

Sources said that USFDA has given a ‘not approved’ rating to new products manufactured at the facility, although this could not be independently confirmed. In the Batamandi plant, USFDA is learnt to have raised objections over the validation of equipment used to manufacture products at the facility.


A detailed questionnaire listing these points and inviting responses from Ranbaxy elicited the following summary response from the company spokesperson, “Our facilities are inspected by USFDA and other regulatory agencies on an ongoing basis.”

Ranbaxy addded, “All resulting comments are addressed by our technical teams who work to satisfy the authorities. We remain committed as always to supply highest-quality products to our customers in India and overseas.” A specific query about whether new products manufactured at Dewas and Batamandi could be exported to the US went unanswered by the spokesperson.

In an e-mail response to ET, an USFDA spokesperson said, “The inspections have concluded. The agency has nothing further to discuss.”

The US is Ranbaxy’s single largest market, and in 2007, its US sales stood at $386 million, accounting for 22.89% of the company’s global sales. It is believed that Ranbaxy’s manufacturing facility in New Jersey is now a major supplier for the US market.

Of course, Ranbaxy is not the only Indian company that has had a run in with USFDA. A few months ago, Sun Pharma had to withdraw batches of generic metformin tablets, used to treat diabetes, on efficacy grounds. A couple of years ago, USFDA had also asked Wockhardt to correct several deficiencies.

This is not the first time the Gurgaon-based Ranbaxy has come under USFDA’s scrutiny either. In February last year, USFDA’s criminal branch conducted a search at the company’s New Jersey facility in the US for alleged document fraud and activities related to sub-standard product manufacturing.

In November last year, Ranbaxy voluntarily recalled 73 million pills of Gabapentin from the US retail market after discovering impurities outside the approved specification limit.

In 2006, USFDA had conducted investigations at the company’s Paonta Sahib plant. While the company said that it has provided the FDA with all the requisite information and data, it is yet to get a clean chit from the regulator.
Ranbaxy’s new owner Daiichi Sankyo is aware of the company’s issues with USFDA.

Daiichi Sankyo president and CEO Takashi Shoda had earlier told ET that it is conducting an independent due diligence on the issue. According to the company’s website, it has manufacturing facilities in 11 countries. Its Indian facilities meet the requirements of all regulatory agencies such as MCA-UK, MCC-South Africa, USFDA and TGA-Australia.
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  #18  
Old 07-02-2008, 01:56 PM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Quote:
Originally Posted by Anonymous View Post
Daiichi Sankyo president and CEO Takashi Shoda had earlier told ET that it is conducting an independent due diligence on the issue.
First you make a bid that is a 50% premium over a company's stock price AND THEN you do due diligence on issues that undermine that company's manufacturing capabilities, and credibility in its biggest market, i.e., the US. Now there's a smart business decision if there ever was one.

A shitload of money for a company that's neck deep in crap - absolutely priceless I tell you.
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  #19  
Old 07-02-2008, 04:17 PM
Anonymous
 
Posts: n/a
Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Quote:
Originally Posted by Anonymous View Post
A shitload of money for a company that's neck deep in crap - absolutely priceless I tell you.
- Two brand new manufacturing facilites that need to be fixed before they have even been commissioned: 50 million dollars.
- Losses from shuttered manufacturing facility facing FDA censure for >2 years: 50 million dollars.
- Fees paid to lawyers worldwide to challenge Lipitor patents: 50 million dollars.
- Selling your piece of crap company to Japanese businessmen who bought the India growth story: PRICELESS.

There are some things money can't buy. For everything else, there's MalvinderCard.
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  #20  
Old 07-02-2008, 07:56 PM
Anonymous
 
Posts: n/a
Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

You can be sure Diiachi has an out if the Reg Due Diligence fails; this deal doesn't closed until next March.

Watch the stock drop like a rock when it happens.

I don't know what the Indian equivalent is but here we say "Don't count your chickens until they hatch."

I hope Malav et al haven't spent the money yet.
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  #21  
Old 07-02-2008, 09:03 PM
Anonymous
 
Posts: n/a
Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

If you read any of the news coverage you would know that Daiichi doesn't have an "out". They're stuck with Ranbaxy, for better or worse.

And if you think that Malvinder didn't disclose the nature of our FDA inspection and DOJ investigation issues to Daiichi before the deal, you are naive.
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  #22  
Old 07-03-2008, 06:44 AM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Actually Daiichi wants to use Ranbaxy facilities in India for making cheap generic products for Japanese market. The market is just opening up to Generic and there is huge potentiality.Being a Japanese company they actually will have edge. They are least bothered on FDA clearence and US generic market. Just see how they forced Ranbaxy to withdraw Lipitor case.
Increasingly US generic market will have less importance for Ranbaxy.
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  #23  
Old 07-03-2008, 08:08 AM
Anonymous
 
Posts: n/a
Banghead Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Hey mam,

Its not that easy to make cheap generics for Japan .The company who has bad history of market complaints , recalls in other markets will be wiped out if they enter Japan with quality standards they call as Quality .They are in big shit now .Japan is the most tough market for Pharma .If Japs sit here and do it , its a different story.Dewas plant tried with Voglibose tablets to Japan and the whole lots were withdrawn and NPI Japan threatened to quit the JV due to that .All this shit wasgoing to hit the roof and Malav smartly sold his stake .Its that simple guys...
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  #24  
Old 07-03-2008, 08:41 AM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Quote:
Originally Posted by Anonymous View Post
If you read any of the news coverage you would know that Daiichi doesn't have an "out". They're stuck with Ranbaxy, for better or worse.

And if you think that Malvinder didn't disclose the nature of our FDA inspection and DOJ investigation issues to Daiichi before the deal, you are naive.
Its not being niave its knowning Malav's character.

Even if Diiachi was dumb enough not to negotiate an out into the contract "fraud" is always an out in any contract.

Diiachi's primary motivation is to obtain manufacturing capacity to support the Japanese market but I doubt they would pay $4.4 B for a majority stake just for that purpose. And if you know anything about the Japanese market you will know that it will be more difficult there to get approvals than the US market.

Sleaze balls in product development, regulatory, and manufacturing will not survive.
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  #25  
Old 07-03-2008, 08:52 AM
Anonymous
 
Posts: n/a
Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Quote:
Originally Posted by Anonymous View Post
Actually Daiichi wants to use Ranbaxy facilities in India for making cheap generic products for Japanese market. The market is just opening up to Generic and there is huge potentiality.Being a Japanese company they actually will have edge. They are least bothered on FDA clearence and US generic market. Just see how they forced Ranbaxy to withdraw Lipitor case.
Increasingly US generic market will have less importance for Ranbaxy.
The US market will have less importance for Ranbaxy because the senior people there didn't have the intellect and integrity to compete effectively.

When Ranbaxy came to the US they had a hudge cost advantage and they blew it. All they had to do was copy (the only thing they are good at) and follow the very clear rules for product development and manufacturing. Now they are doing more and more manufacturing in the US giving away whatever remaining advantage they may have had.

But they thought they could put the crap onto the US market that they foist upon the citizens of India and unfortunately because for so many years the FDA has been a paper tiger they got away with it. Now these visionless idiots find themselves one of the poster children for the FDA's enforcement of substandard foreign manufacturers.

Maybe someone can tell me why the citizens of India are not outraged; they have been exposed to Ranbaxy's low quality products for a lot longer than the US market.
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  #26  
Old 07-13-2008, 09:25 AM
Anonymous
 
Posts: n/a
Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

One senior ex-Ranbaxy pharma development fraud has joined a domestic company. The company had a recall of 6 lacs vials of injection. Poor development shows. poor company was doing good in domestic and this ranbaxy fraud is leading them to problems. The company is expected to have more recalls from Europe.
The US FDA has hold its approval inspite of the inspection that happened six months back. it is expected that there will a inspection of this facility agin jointly by FDA and European agency. Company's beware of taking senior ranbaxy people especially in pharma they are all frauds!!
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  #27  
Old 07-14-2008, 02:19 AM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Which is this Indian company? We got to read about a recall from france from this company. This came in Economic Times. I was shocked to see the response of the company. They said that value of recall material is fraction of the turnover. They will face the heat when UK agency's will come to their facility. All exports done till today will have to be recalled.
how has Pharma research person contributed to this recall. Can anyone tell me.
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  #28  
Old 07-14-2008, 03:32 PM
Anonymous
 
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Default Re: Recalls and more recalls-Now Alkem

Looks like this is Alkem. One ex-Ranbaxy has joined them recently. He is the same guy who got into limelight with Cipro OD but later on was found to be a fake! He was asked to leave Ranbaxy by Dr. Sen once Dr. Sen rejoined Ranbaxy. He is the person who is responsible along with Parekh to take paonta facility to shits. Both led to disaster at paonta- one from manufacturing adjustments and the other one with fake formulations.
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  #29  
Old 07-15-2008, 04:58 AM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Not only pharma Head, we heard the new Quality head of Alkem also is fraud. All problems of ranbaxy was created in their times only. Alkem beware you are going to go to dogs.
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  #30  
Old 07-15-2008, 05:03 AM
Anonymous
 
Posts: n/a
Default Re: Recalls and more recalls-Now Alkem

Quote:
Originally Posted by Anonymous View Post
Looks like this is Alkem. One ex-Ranbaxy has joined them recently. He is the same guy who got into limelight with Cipro OD but later on was found to be a fake! He was asked to leave Ranbaxy by Dr. Sen once Dr. Sen rejoined Ranbaxy. He is the person who is responsible along with Parekh to take paonta facility to shits. Both led to disaster at paonta- one from manufacturing adjustments and the other one with fake formulations.
Take a crash course in pharma man!! The said recalled injection is sterile API fill , no formulation development here. Take a life and don’t shit your personal grudges in this forum. It is perhaps purely a manufacturing/QA related issue rather that development.
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  #31  
Old 07-15-2008, 05:04 AM
Anonymous
 
Posts: n/a
Default Re: Alkem recall

Some idiot guy also joined Alkem,who was sacked from DRL for manipulating datas in their oncology plant.Hence, unsuccessful inspection.He was sacked immediately.
He then became a property dealer for a while.He was earlier commented by his ex-employer as manipulator in Ranbaxy days.And was chuked out.
Now again he has commited blunder: Rather than justifying his quality standards in ET he was replying on commercial issues. How PR is handled in Alkem: this is the right example. OR do they even know PR and Corp. Comm.
There are still breads available for such FRAUDS in Indian Pharma industry.
Also heard about him protecting one of the plant head in theft and financial manipulation.
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  #32  
Old 07-15-2008, 07:12 AM
Anonymous
 
Posts: n/a
Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Hey
Some more fakes are still with Ranbaxy. Abha Pant ,Chandrasekhar etc tops the list. Actually , Ranbaxy R&D is the breeding centre of Politicians. They have given more politicians than products
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  #33  
Old 07-15-2008, 10:34 AM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Quote:
Originally Posted by Anonymous View Post
Hey
Some more fakes are still with Ranbaxy. Abha Pant ,Chandrasekhar etc tops the list. Actually , Ranbaxy R&D is the breeding centre of Politicians. They have given more politicians than products
You are right. Many more are still there. Tauseef, Parekh and many more.
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  #34  
Old 07-15-2008, 12:13 PM
Anonymous
 
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Default Re: Recalls and more recalls-Now Alkem

Quote:
Originally Posted by Anonymous View Post
Take a life and don’t shit your personal grudges in this forum. It is perhaps purely a manufacturing/QA related issue rather that development.
Hahaha - I presume you're not inciting someone to commit murder and instead meant to say GET A LIFE!

Though it is a Freudian slip, given the quality (or lack thereof) of drugs this company is accused of producing.
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  #35  
Old 07-16-2008, 04:20 AM
Anonymous
 
Posts: n/a
Default Re: Recalls and more recalls-Now Alkem

Quote:
Originally Posted by Anonymous View Post
Hahaha - I presume you're not inciting someone to commit murder and instead meant to say GET A LIFE!

Though it is a Freudian slip, given the quality (or lack thereof) of drugs this company is accused of producing.
Infact one more ex-Ranbaxy guy is having his second stint in Alkem. He has been sacked following the DRL's oncology's plant unsuccessful FDA inspection.He is a great manipulator and was even questioned by Ranbaxy's Owner as express manipulator. He was even commenting on Alkem's recall. Although the label claim is BP he said its passing in USP.This how he defends quality systems and was answering the commercial issues also. Does he understand any bit of commercial. AND What about PLIVA's quality complaints. He manipulated their filings also. NOW Alkem is running DUAL technology.The TWOSOME.
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  #36  
Old 07-17-2008, 02:33 AM
Anonymous
 
Posts: n/a
Default Re: Recalls and more recalls-Now Alkem

Quote:
Originally Posted by Anonymous View Post
Hahaha - I presume you're not inciting someone to commit murder and instead meant to say GET A LIFE!

Though it is a Freudian slip, given the quality (or lack thereof) of drugs this company is accused of producing.

Please read the news from top most pharma journal of the world
Three lakh injections are recalled by Alkem from worldwide
New Delhi,India
09 Jul 2008

Alkem is recalling approximately 3 lakh injection from a number of overseas markets. Source of the drug was Indian distribution firm Synergia Life Sciences for supply France, African markets and a few global NGOs.

It was told to Alkem that the drug had failed. Alkem said that the drug had passed the test when they tested it in their laboratory then the drugs were tested again in European laboratories and found the adverse result. Then company decided to recall the product.

Synergia is a business partner of CSEP. This is a part of multi-million dollar pharmaceutical conglomerate based in France. The company claims that the injection has passed the British Pharmacopoeia standards, according to supply agreement and the labels the drugs. Some parts of the US pharmacopoeia are used to claim that the drug has not failed. It was found that the recall would have very little as the value of the order is 0.011% of its Rs 1,000 crore sales. Also there is 2% variation between drugs tested in different laboratories.
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  #37  
Old 07-17-2008, 02:35 AM
Anonymous
 
Posts: n/a
Default Re: Alkem recall

Quote:
Originally Posted by Anonymous View Post
Some idiot guy also joined Alkem,who was sacked from DRL for manipulating datas in their oncology plant.Hence, unsuccessful inspection.He was sacked immediately.
He then became a property dealer for a while.He was earlier commented by his ex-employer as manipulator in Ranbaxy days.And was chuked out.
Now again he has commited blunder: Rather than justifying his quality standards in ET he was replying on commercial issues. How PR is handled in Alkem: this is the right example. OR do they even know PR and Corp. Comm.
There are still breads available for such FRAUDS in Indian Pharma industry.
Also heard about him protecting one of the plant head in theft and financial manipulation.
NEW DELHI: Alkem is recalling six batches, or around three lakh, of ampicillin injection from several overseas markets after discovering that the drugs did not contain the specified dosage. The drug was sourced by an Indian distribution firm Synergia Life Sciences to supply France, African markets and a few global NGOs.

In October last year, Alkem was told that the drug had failed. However, Alkem said the drug passed the test when the company independently conducted tests in its own laboratories. Subsequently, the drugs were re-tested in three more European laboratories, including AFFSAPS, (the French equivalent of USFDA) which also showed adverse results. The Indian company finally decided to recall its product last month but maintains that the drugs still pass the US standards.

“Though Alkem is on very sure grounds with respect to the quality of the consignment, we had taken a decision to recall the consignment, “ said Alkem president, corporate quality assurance, Dr K N Singh. Alkem alleged that Synergia and CSEP (Centre Specialities Export Pharma) was trying to malign the company after it (Alkem) decided to tap these markets on its own. ”We feel that CSEP is coercing us into continuing commercial relations with it by bringing up this matter regarding. It’s a minor variation in assay (potency),“ Dr Singh added.

Synergia is a strategic business partner of CSEP, which is a part of a multi-million dollar pharmaceutical conglomerate based in France. Synergia CEO Tobby Simon however said that the Mumbai-based company was using the contractual loss to cover up the failure and its refusal to take responsibility.

“According to the supply agreement and the labels in the drugs, the company claims that the injection has passed the British Pharmacopea standards. They are conveniently using parts of the US Pharmacopoeia to claim that the drug has not failed, “ Mr Simon added.

Alkem has said that the assay (potency) value in the samples with CSEP was in the range of 91 to 93% as against the British standard of 95–105%. Even the US standards allows for the assay values to be in the range of 90 to 115%.
He, however, said that the recall would have little implication on the company as the value of the order is 0.011% of its Rs 1,000 crore sales.

Also, as per the globally analytical norms, there is usually a 2% variation between drugs tested in different laboratories.
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  #38  
Old 07-17-2008, 02:40 AM
Anonymous
 
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Default Re: Recalls and more recalls-Now Alkem

Quote:
Originally Posted by Anonymous View Post
Take a crash course in pharma man!! The said recalled injection is sterile API fill , no formulation development here. Take a life and don’t shit your personal grudges in this forum. It is perhaps purely a manufacturing/QA related issue rather that development.
http://www.pharmalot.com/2008/07/con...y-allegations/
Please go to the link above friend and tell the world that it is all manipulations at the devlopment stage. bioequivalence studies are not managed by QA!
All current and ex Formulation heads of Ranbaxy-pack your bags you are going to be screwed by Malvinder.
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  #39  
Old 08-31-2010, 06:09 PM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

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If all is nonsense then read the story in eco times india and many international dailies:

NEW DELHI: Two manufacturing facilities of Ranbaxy Laboratories are learnt to have come under the scanner of the US Food and Drug Administration (USFDA), the drug regulatory body in the US.

All pharma companies have to get USFDA approval for selling medicines in the US. This is in addition to the company’s Paonta Sahib (Himachal Pradesh) plant, which has been the subject of USFDA investigations for the past two years.

According to sources, USFDA carried out inspections at Ranbaxy’s manufacturing plant at Dewas (Madhya Pradesh) and Batamandi (Himachal Pradesh) earlier this year. USFDA is learnt to have raised concerns over cross contamination at the Dewas plant.

Sources said that USFDA has given a ‘not approved’ rating to new products manufactured at the facility, although this could not be independently confirmed. In the Batamandi plant, USFDA is learnt to have raised objections over the validation of equipment used to manufacture products at the facility.


A detailed questionnaire listing these points and inviting responses from Ranbaxy elicited the following summary response from the company spokesperson, “Our facilities are inspected by USFDA and other regulatory agencies on an ongoing basis.”

Ranbaxy addded, “All resulting comments are addressed by our technical teams who work to satisfy the authorities. We remain committed as always to supply highest-quality products to our customers in India and overseas.” A specific query about whether new products manufactured at Dewas and Batamandi could be exported to the US went unanswered by the spokesperson.

In an e-mail response to ET, an USFDA spokesperson said, “The inspections have concluded. The agency has nothing further to discuss.”

The US is Ranbaxy’s single largest market, and in 2007, its US sales stood at $386 million, accounting for 22.89% of the company’s global sales. It is believed that Ranbaxy’s manufacturing facility in New Jersey is now a major supplier for the US market.

Of course, Ranbaxy is not the only Indian company that has had a run in with USFDA. A few months ago, Sun Pharma had to withdraw batches of generic metformin tablets, used to treat diabetes, on efficacy grounds. A couple of years ago, USFDA had also asked Wockhardt to correct several deficiencies.

This is not the first time the Gurgaon-based Ranbaxy has come under USFDA’s scrutiny either. In February last year, USFDA’s criminal branch conducted a search at the company’s New Jersey facility in the US for alleged document fraud and activities related to sub-standard product manufacturing.

In November last year, Ranbaxy voluntarily recalled 73 million pills of Gabapentin from the US retail market after discovering impurities outside the approved specification limit.

In 2006, USFDA had conducted investigations at the company’s Paonta Sahib plant. While the company said that it has provided the FDA with all the requisite information and data, it is yet to get a clean chit from the regulator.
Ranbaxy’s new owner Daiichi Sankyo is aware of the company’s issues with USFDA.

Daiichi Sankyo president and CEO Takashi Shoda had earlier told ET that it is conducting an independent due diligence on the issue. According to the company’s website, it has manufacturing facilities in 11 countries. Its Indian facilities meet the requirements of all regulatory agencies such as MCA-UK, MCC-South Africa, USFDA and TGA-Australia.
See http://oralstemcell.com/products/ant...romycin/order/
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  #40  
Old 03-12-2011, 10:02 AM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

The FDA needs to come in a close this company. Everything they do goes against compliance. The New Jersey offce needs to be the first one closed and take AA back to India where he belongs. Sounds ike more people who know what is going on illegally on the inside need to come forward and expose this company for who they really are.
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  #41  
Old 03-17-2011, 04:58 PM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

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The FDA needs to come in a close this company. Everything they do goes against compliance. The New Jersey offce needs to be the first one closed and take AA back to India where he belongs. Sounds ike more people who know what is going on illegally on the inside need to come forward and expose this company for who they really are.
Was AA brought from India to the US specifically to run US field force and operations? If so, how long ago?
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  #42  
Old 05-08-2011, 01:38 AM
Anonymous
 
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Thumbs up Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Dear All... for what so ever reason, because of some improper management a great indian Co. is having the days what it should not be. Hope the best, there are many changes in the seniour level mgmt, USFDA Deal for One billon Dollar & Lipitor rights will make the company to grow. And please dont blame some.... there may be many more also. Leave the worst hope the best......... Good luck RANBAXY.....................
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  #43  
Old 05-12-2011, 04:25 AM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Rajeev mathur has finally resigned,
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  #44  
Old 08-15-2011, 02:13 PM
Mukesh dua
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Mathur ma ke land, chut ke dhakkan, lode ke makhhan... With love mukesh dua
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  #45  
Old 08-15-2011, 08:13 PM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

It is sop not fraud
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  #46  
Old 08-17-2011, 11:17 AM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

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Originally Posted by Anonymous View Post
It is sop not fraud
It may just be the sop, or it may be the curry. Both are good, but both require an acquired taste! Always be aware of the Pashtoons!
M. Pendiwalli
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  #47  
Old 03-24-2012, 02:01 PM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Hi forum,

I don't mean to be disrespectful, I'm just asking for some cultural insight. I'm from a small company in Asia. We have several Indian expats heading our quality unit.

Committing fraud, falsifying documents, etc seems to be sop for them. And they're leading our quality unit! I'm horrified and try to reverse their actions when I can, but most of the time i can't -I am their subordinate and they expect deference from their staff.

How can I change their attitude? I think it has to do with the culture of their previous workplaces since they think it's the norm everywhere.

I know they are doing irreparable harm to the company's reputation - and by 'leading' by example. Any help you could give would be most appreciated.
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  #48  
Old 03-27-2012, 02:59 PM
Anonymous
 
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Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Ooweeee!
Kickin' ass in Calcutta!
Dippin' in New Delhi!
Prancin' in Punjab!
Boppin' in Bombay!
The Pashtoons are a- comin'! Not a single Patel will be safe!
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  #49  
Old 04-24-2012, 03:15 PM
Anonymous
 
Posts: n/a
Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Quote:
Originally Posted by Anonymous View Post
Ooweeee!
Kickin' ass in Calcutta!
Dippin' in New Delhi!
Prancin' in Punjab!
Boppin' in Bombay!
The Pashtoons are a- comin'! Not a single Patel will be safe!
No, please not in Calcutta!
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  #50  
Old 05-02-2012, 02:21 PM
Anonymous
 
Posts: n/a
Default Re: Fraud Unearthed at Ranbaxy Bata Mandi ,Paonta Sahib plant

Quote:
Originally Posted by Anonymous View Post
No, please not in Calcutta!
I agree. I will defend my family and my home in Calcutta with every drop of life in my very being!
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