Indena's new high containment facility gets full marks from US FDA
A new facility that will produce paclitaxel by semisynthesis has been inaugurated by Indena at its main factory in Settala, near Milan. The semisynthetic active ingredient will be marketed alongside natural Paclitaxel.
A new facility that will produce paclitaxel by semisynthesis has been inaugurated by Indena at its main factory in Settala, near Milan. The semisynthetic active ingredient will be marketed alongside natural Paclitaxel.
Semisynthetic paclitaxel is obtained using a process patented by Indena, based on the 10-Deacetylbaccatin, a molecule extracted from yew trees (Taxus baccata) cultivated in the company's own plantations. The 10-Deacetylbaccatin acts as an intermediate for the production of various antitumour molecules such as paclitaxel, docetaxel.
The processes used in the production of natural paclitaxel underwent an inspection in March by the US FDA. The inspectors reported total conformance with GMP standards and renewed the company's 'permit' to continue to export active ingredients to the US.
'This new high-containment plant will help Indena strengthen its position as world leader in the production and semisynthesis of taxanes,' said commercial director Daniele Giavini. 'The aim of the company is to respond to market demands, by moving over to a more competitive semisynthetic active; as with all company products we have direct control over the entire supply chain from initial plantation to the end product.'