The US FDA has warned Teva Pharmaceutical Industries about its facility in Godollo, Hungary over ongoing concerns about manufacturing operations.
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.
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 has launched an auto-injector designed to deliver higher viscosity drug formulations.
Acura Pharmaceuticals has licensed rights to use it anti-abuse technology to develop drug formulations to prodrug firm Kempharm.
Samsung Bioepis has contracted Catalent to provide fill finish services for its Enbrel (etanercept) biosimilar, Benepali.
Nucleic acid manufacturer Nitto Denko Avecia has agreed to buy Irvine Pharmaceutical Services and Avrio Biopharmaceuticals in deals designed to expand its production business.