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Teva's troubled Godollo plant earns firm US FDA warning letter

The US FDA has warned Teva Pharmaceutical Industries about its facility in Godollo, Hungary over ongoing concerns about manufacturing operations.

Lannett compiling evidence to block FDA efforts to pull generic Concerta ANDA

Lannett is confident it can prove the extended release tech in its Concerta generic is equivalent to the original after the US FDA said it will seek withdrawal of firms ANDA.

Laxachem Organics ban not linked to B. cepacia outbreak says US FDA

APIs made by Laxachem Organics pvt ltd were not the source of bacteria in Pharmatech laxatives linked to a spate of Burkholderia cepacia infections according to the US FDA.

Bespak launches autoinjector for high viscosity formulations; signs global pharma deal

Bespak has launched an auto-injector designed to deliver higher viscosity drug formulations.

Kempharm opts for Acura's anti-abuse tech in $3.5m deal

Acura Pharmaceuticals has licensed rights to use it anti-abuse technology to develop drug formulations to prodrug firm Kempharm.

Samsung Bioepis contracts Catalent to help commercialize Benepali

Samsung Bioepis has contracted Catalent to provide fill finish services for its Enbrel (etanercept) biosimilar, Benepali.

Nitto Denko Avecia to buy Irvine and Avrio to expand offering

Nucleic acid manufacturer Nitto Denko Avecia has agreed to buy Irvine Pharmaceutical Services and Avrio Biopharmaceuticals in deals designed to expand its production business.

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