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Set Alert for Manufacturing

FDA Warns Teva's Actavis Over Quality Concerns

Quality issues and inconsistencies with laser-drilled tablet manufacturing processes at Teva’s Actavis have been flagged up by the FDA following an audit last July at the firm’s plant in Florida, US. The agency noted that similar cGMP observations were found during inspections in 2013, 2016 and 2017.

United States Manufacturing

Akorn Faces Hurdles In Returning To Path Of Profitable Growth

A new management team at Akorn is making progress on moving on from Fresenius Kabi’s ill-fated takeover bid; but putting manufacturing problems behind the US injectables and ophthalmics specialist is proving difficult.
Business Strategies Sales & Earnings

India’s Orchid Pharma Is Back On The Market

An acrimonious end to a takeover bid for bankrupt Indian player Orchid Pharma has reopened the pathway for previously interested parties to table fresh bids.
India Generic Drugs

FDA Expresses Concern As Third Nitrosamine Impurity Found In Certain ARB Medicines

The FDA is “deeply concerned” after the presence of a third nitrosamine impurity is found in certain generic ARB medicines; Hetero Labs recalls 87 lots of losartan tablets after recent FDA tests show NMBA levels higher than the agency’s interim acceptable intake limits.

FDA Generic Drugs

Selexis And Turgut Expand Biosimilar Partnership With A Further Two Licensing Agreements

Selexis and Turgut have further expanded their biosimilar development partnership by signing commercial license agreements for two undisclosed biosimilar antibodies. Building on previous deals signed in July 2016 and December 2017, the companies are now working together to develop biosimilars to treat oncology and inflammatory diseases.

Biosimilars Deals

FDA Invites Comment On Continuous Manufacturing

Draft guidance on quality considerations for continuous manufacturing has been published by the US Food and Drug Administration with a 90-day comment period.

Manufacturing Regulation
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