> The U.S. asked that the European Union include it on its list of countries with acceptable GMP standards and to accept FDA inspections of API makers to meet a new law that requires all imported APIs to meet EU standards. Item
> The European Medicines Agency intends to incorporate into its annexes on GMPs some guidance already issued by the International Conference on Harmonization (ICH) and the FDA. Story
> Lonza CEO Richard Ridinger said investors should expect lower earnings growth this year as the API and chemical company cuts manufacturing further to get costs down. Story
> Indian drug company Torrent Pharma has recalled two batches of its acidity drug Ranitidine in India after the Drug Controller General of India (DCGI) determined that they didn't meet quality standards. Item
> Two New Jersey men have been arrested for distributing thousands of fake Viagra pills. Story
> Cytovance Biologics said it will expand its current mammalian production capabilities to include a 1,000-liter SUB bioreactor, a 5,000-liter stainless steel bioreactor and an automated fill/finish line. Release
And Finally... An analysis by Pharmaceutical Commerce finds that if you take last year's FDA drug approvals, add in extension approvals and then toss in vaccine approvals, you find out that 38% were for cold-chain products. Item