FDA confuses manufacturers with 'crude heparin' meaning; EMA to rely more on RTRT for quality tests;

> Merck ($MRK) and Celsus Laboratories have both responded to draft guidance from the FDA intended to keep adulterated heparin out of the supply chain by saying FDA needs to clear up confusion over what it means when it refers to "crude heparin." Story

> The European Medicines Agency has released new guidelines that will allow drug manufacturers to extend the use of real-time release testing (RTRT) for checking the quality of their products instead of relying only on end-product testing. Article

> Contract manufacturer AMRI ($AMRI) will develop and manufacture an influenza antiviral for Biota Holdings. Story

> Agennix, which already has a supply agreement with DSM Pharmaceutical Products for the anticipated commercial production of its drug talactoferrin, said it has selected Lonza to come in as a secondary supplier. More

> Indian custom research and manufacturing services company Jubilant Life Sciences is investing $100 million in a manufacturing facility in Gujarat where it will make vitamin B3 and 3-Cyanopyridine. Item

> The pollution-control board in Andhra Pradesh in India has closed 8 bulk drug manufacturing factories there for pollution. News

 

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