Business Daily from THE HINDU group of publications
Saturday, Nov 15, 2008
ePaper | Mobile/PDA Version | Audio | Blogs
Business Daily from THE HINDU group of publications Saturday, Nov 15, 2008 ePaper | Mobile/PDA Version | Audio | Blogs |
|
|
|
|
|
Corporate
-
Regulatory Bodies & Rulings FDA observation not to affect supply: Lupin ‘Many of the observations have been already addressed’ Our Bureau Mumbai, Nov. 14 Lupin has said the recent inspectional observations made by the regulatory United States Food and Drug Administration (FDA) would not affect the supply of its products manufactured at its Mandideep plant. The FDA had listed 15 inspectional observations, the company told the Bombay Stock Exchange. The inspection was a routine Good Manufacturing Practices audit, and the observations were procedural in nature, a company spokesperson told Business Line. Details of the FDA observations were not divulged. Eight of the observations have been already addressed and the rest will be handled expeditiously, the company said. However, Lupin added, the supply of products from this plant and its pending applications at the US FDA do not get affected by the development. With details of the nature of observations still not known, it does not seem to be in the same league as the recent observations made by the US regulator, regarding Sun Pharma’s US subsidiary or the more high-profile recall that happened with Ranbaxy, said a pharma analyst. In the case of Sun’s subsidiary Caraco, new product approvals were expected to see a delay, following the FDA’s observations on quality control. In Ranbaxy’s case, 30 drugs were blacklisted from being imported into the US. Lupin shares were down 4.5 per cent at Rs 581.25 on the BSE. More Stories on : Regulatory Bodies & Rulings | Pharmaceuticals
Article E-Mail :: Comment :: Syndication :: Printer Friendly Page
|
|
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
|
