USFDA recalls Dr Reddy's anti-psychotic drug

Asks pharma major to recall a batch of Quetiapine Fumarate tablets citing the failed dissolution test requirements

The US Food and Drug Administration (USFDA) has asked Dr Reddy's Laboratories (DRL) to recall a batch of anti-psychotic drug Quetiapine Fumarate tablets of 25 mg, citing the failed dissolution test requirements.

The Hyderabad-based pharmaceutical major had launched its generic Quetiapine Fumarate tablets in the US market in March this year following the approval by the USFDA.

Used to treat Schizophrenia or bipolar disorder, the drug is a bioequivalant version of AstraZeneca's blockbuster drug Seroquel, which had sales revenues of $4.6 billion in the US market for the year ended December 2011.

Referring to a particular lot (C203090 expiry 03/2014) of the drug, the enforcement report putout by the said that during the analysis of long term stability studies at three-month time point, an OOS (out of specification) was reported for Quetiapine Fumarate tablets.

"This was something that happened in September this year. It was a very small batch and has no significance what so ever on Dr Reddy's sales of Quetiapine Fumarate tablets in the US market," said a company representative on condition of anonymity.

The company had produced the drug at its Bachupally facility near Hyderabad, according to the enforcement report.

This is a latest case of drug recall by an Indian company following the Ranbaxy Laboratories' voluntary recall of a few batches of its Lipitor generic drug and Aurobindo Pharma's voluntary recall of a batch of Zolpidem from the US market this year.

Two other Indian companies, Sun Pharmaceutical and Lupin had also received approval to launch Quetiapine Fumarate in the US market around the same time as Dr Reddy's.

DRL's scrip was trading at Rs 1,820 on the BSE today, up by Rs.11.20 or 0.62% over the previous day's close.

image
Business Standard
177 22
Business Standard

USFDA recalls Dr Reddy's anti-psychotic drug

Asks pharma major to recall a batch of Quetiapine Fumarate tablets citing the failed dissolution test requirements

Dasarath Reddy Bhuswam  |  Hyderabad 

The US Food and Drug Administration (USFDA) has asked Dr Reddy's Laboratories (DRL) to recall a batch of anti-psychotic drug Quetiapine Fumarate tablets of 25 mg, citing the failed dissolution test requirements.

The Hyderabad-based pharmaceutical major had launched its generic Quetiapine Fumarate tablets in the US market in March this year following the approval by the USFDA.

Used to treat Schizophrenia or bipolar disorder, the drug is a bioequivalant version of AstraZeneca's blockbuster drug Seroquel, which had sales revenues of $4.6 billion in the US market for the year ended December 2011.

Referring to a particular lot (C203090 expiry 03/2014) of the drug, the enforcement report putout by the said that during the analysis of long term stability studies at three-month time point, an OOS (out of specification) was reported for Quetiapine Fumarate tablets.

"This was something that happened in September this year. It was a very small batch and has no significance what so ever on Dr Reddy's sales of Quetiapine Fumarate tablets in the US market," said a company representative on condition of anonymity.

The company had produced the drug at its Bachupally facility near Hyderabad, according to the enforcement report.

This is a latest case of drug recall by an Indian company following the Ranbaxy Laboratories' voluntary recall of a few batches of its Lipitor generic drug and Aurobindo Pharma's voluntary recall of a batch of Zolpidem from the US market this year.

Two other Indian companies, Sun Pharmaceutical and Lupin had also received approval to launch Quetiapine Fumarate in the US market around the same time as Dr Reddy's.

DRL's scrip was trading at Rs 1,820 on the BSE today, up by Rs.11.20 or 0.62% over the previous day's close.

RECOMMENDED FOR YOU

USFDA recalls Dr Reddy's anti-psychotic drug

Asks pharma major to recall a batch of Quetiapine Fumarate tablets citing the failed dissolution test requirements

The US Food and Drug Administration (USFDA) has asked Dr Reddy's Laboratories (DRL) to recall a batch of anti-psychotic drug Quetiapine Fumarate tablets of 25 mg, citing the failed dissolution test requirements.

The US Food and Drug Administration (USFDA) has asked Dr Reddy's Laboratories (DRL) to recall a batch of anti-psychotic drug Quetiapine Fumarate tablets of 25 mg, citing the failed dissolution test requirements.

The Hyderabad-based pharmaceutical major had launched its generic Quetiapine Fumarate tablets in the US market in March this year following the approval by the USFDA.

Used to treat Schizophrenia or bipolar disorder, the drug is a bioequivalant version of AstraZeneca's blockbuster drug Seroquel, which had sales revenues of $4.6 billion in the US market for the year ended December 2011.

Referring to a particular lot (C203090 expiry 03/2014) of the drug, the enforcement report putout by the said that during the analysis of long term stability studies at three-month time point, an OOS (out of specification) was reported for Quetiapine Fumarate tablets.

"This was something that happened in September this year. It was a very small batch and has no significance what so ever on Dr Reddy's sales of Quetiapine Fumarate tablets in the US market," said a company representative on condition of anonymity.

The company had produced the drug at its Bachupally facility near Hyderabad, according to the enforcement report.

This is a latest case of drug recall by an Indian company following the Ranbaxy Laboratories' voluntary recall of a few batches of its Lipitor generic drug and Aurobindo Pharma's voluntary recall of a batch of Zolpidem from the US market this year.

Two other Indian companies, Sun Pharmaceutical and Lupin had also received approval to launch Quetiapine Fumarate in the US market around the same time as Dr Reddy's.

DRL's scrip was trading at Rs 1,820 on the BSE today, up by Rs.11.20 or 0.62% over the previous day's close.

image
Business Standard
177 22

Upgrade To Premium Services

Welcome User

Business Standard is happy to inform you of the launch of "Business Standard Premium Services"

As a premium subscriber you get an across device unfettered access to a range of services which include:

  • Access Exclusive content - articles, features & opinion pieces
  • Weekly Industry/Genre specific newsletters - Choose multiple industries/genres
  • Access to 17 plus years of content archives
  • Set Stock price alerts for your portfolio and watch list and get them delivered to your e-mail box
  • End of day news alerts on 5 companies (via email)
  • NEW: Get seamless access to WSJ.com at a great price. No additional sign-up required.
 

Premium Services

In Partnership with

 

Dear Guest,

 

Welcome to the premium services of Business Standard brought to you courtesy FIS.
Kindly visit the Manage my subscription page to discover the benefits of this programme.

Enjoy Reading!
Team Business Standard