Canada Lifts Apotex Indian Sites Ban, FDA To Follow?
This article was originally published in PharmAsia News
Executive Summary
Canada has lifted a ban on imports from two Indian pharmaceutical plants owned by Canadian generics giant Apotex, a year after halting shipments over allegations that company employees had faked drug test results.
You may also be interested in...
Manufacturing Compliance In Brief: Seven US FDA Warning Letters, Two EU GMP Non-Compliance Notices
Cross-contamination problems figure prominently in notices from US and European agencies that were sent to firms in India and other Asian countries.
Share Fillip As Indian Pharma Crests US Regulatory Hump
For the last few years, Indian generic companies have been making headlines for all the wrong reasons, rapped by the US Food and Drug Administration over problems ranging from fudged test results to poor-quality manufacturing standards. But lately, the firms have been enjoying a run of good regulatory tidings, giving a fillip to their share prices.
Biocon, Quark Win Pioneering Indian Nod For RNAi Eye Therapy Trial
Asia’s biggest biotech company, India’s Biocon Ltd, has announced it will conduct what it says is the first-ever clinical trial of a siRNA therapy in India with US partner Quark, is aimed at tackling a rare eye condition.