Manufacturing news in brief
pharmafile | August 5, 2013 | News story | Manufacturing and Production | Fresenius Kabi, Gallus, NextPharma Technologies, PharmaForm, Sanofie Chimie, uniQure
New contracts for Sanofi and Gallus, Fresenius Kabi sacks Indian managers, facility news from UniQure and Nextpharma plus BiG’s acquisition of Pharmaform.
Sanofi’s contract manufacturing subsidiary Sanofi Chimie has been given a contract by Vivus to supply the active pharmaceutical ingredient for Stendra (avanafil), its fast-acting product for erectile dysfunction which was approved in the US last year and has been submitted in the EU. Sanofi Chimie will supply the API exclusively in the US and certain territories, as well as on a non-exclusive basis in the EU and Latin America. Vivus is also in the process getting Sanofi Chimie qualified as a supplier of bulk avanafil tablets. Until the completion of the qualification and subsequent approval, which is expected by June 2015, Vivus and its partners will continue to source avanafil API from Mitsubishi Tanabe.
Genzyme has awarded a contract to manufacture its enzyme replacement therapy for Niemann-Pick B disease – a rare condition found mainly among the Ashkenazi Jewish population – to US CMO Gallus Biopharmaceuticals. Gallus will provide process and method development, scale-up, clinical supply, and prepare for commercial manufacturing of the therapy, which is about to enter a six-month Phase 1b trial.
Fresenius Kabi says it has sacked managers at an API facility in Kalyani, India, that was sent a warning letter by the FDA earlier this month, according to an in-PharmaTechnologist.com report. The letter said an inspection earlier this year uncovered not only failures in GMP compliance but also deliberate attempts by workers at the plant to mislead inspectors and hide falsified data.
Dutch gene therapy specialist UniQure is planning to build a 55,000 sq. ft. manufacturing plant in Lexington, Massachusetts, which is expected to be operational by 2015. The plant will produce commercial-scale supplies of products based on its adeno associated virus (AAV) vector, and will significantly expand current production capacity at its plant in Amsterdam. UniQure is funding the investment with a $10 million fundraising from Hercules Technology Growth Capital.
Contract packager Nextpharma Tehnologies has doubled capacity at its facility in Bielefeld, Germany, for the manufacture of products in stick packs (tube sachets). The floor space of the production area has been expanded to 3,400 sq. m. and three new stick packaging lines are already operational according to the company.
Biotech Investment Group (BiG) has acquired contract formulation specialist PharmaForm and re-launched the business as Formex. The company specialises in small molecule formulations development, using techniques such as hot melt extrusion, spray dried dispersions and drug layering, as well as offering small-scale finished dose manufacturing.
Phil Taylor
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