Business Daily from THE HINDU group of publications
Tuesday, Apr 01, 2008
ePaper | Mobile/PDA Version
Business Daily from THE HINDU group of publications Tuesday, Apr 01, 2008 ePaper | Mobile/PDA Version |
|
|
|
|
|
|
|
Corporate
-
Standards & Benchmarks
Our Bureau Mumbai, March 31 Sun Pharma’s US-based subsidiary Caraco has been asked by the US regulatory authority to withdraw batches of generic metformin tablets, used to treat diabetes, on grounds of efficacy. The Class II recall of seven lots of the drug covered different strengths of the medicine, according to the US Food and Drug Administration (FDA). “Some tablets may be undersized or oversized, which will result in the patient not receiving the expected dose,” the FDA said. Sun Pharma holds 76 per cent equity in Caraco Pharmaceutical Laboratories Ltd. The Mumbai-based drug maker did not comment on the issueThe regulatory authority defines a class II recall as a situation where the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Further, the regulator said that 22,156 bottles of the medicine were distributed across the US and the recall was nationwide. No major impactAn analyst said that Metformin was not a major revenue-spinner for Indian drug companies that have flocked to the US to sell generic Metformin. The competition in the segment keeps prices low and hence the recall would have but a small impact on Sun Pharma, the analyst said. Also, he pointed out, the efficacy issue seems to be manufacturing-related problem. Late last year, Ranbaxy had initiated a recall of epilepsy drug Gabapentin in the US. The recall was a Class III recall, defined by the regulatory authority as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. More Stories on : Standards & Benchmarks | Pharmaceuticals | Sun Pharmaceutical Industries Ltd
Article E-Mail :: Comment :: Syndication :: Printer Friendly Page
|
Stories in this Section |
 |
|
The Hindu Group: Home | About Us | Copyright | Archives | Contacts | Subscription Group Sites: The Hindu | The Hindu ePaper | Business Line | Business Line ePaper | Sportstar | Frontline | The Hindu eBooks | The Hindu Images | Home |
Copyright © 2008, The
Hindu Business Line. Republication or redissemination of the contents of
this screen are expressly prohibited without the written consent of
The Hindu Business Line
|