Will start making submissions to US FDA next year
Aenova said at CPhI that the leasing of the FDA-certified factory in Lyon, France from SkyePharma puts the company in a strong position to develop its US sales.
The Lyon factory produces tablets, hard capsules and packaging, with 90% of products already going to the US market.
Heiner Hoppmann, chief executive of Aenova, said the firm was pleased with the progress made with the integration process since the announcement in August. He said Aenova would continue to contract manufacture products for SkyePharma at the Lyon plant and would also transfer other CMO business to the site.
‘In addition, we hope to co-develop products with partners interested in selling to the US,’ he said.
The Paehl, Germany headquartered firm will need FDA approval before it can sell co-developed products into the US market, and will make its first submissions to the FDA next year.
Alongside this, Aenova will offer a comprehensive pharmaceutical development service. In future, the firm will take responsibility for formulation and process development, analysis and the stability testing of raw materials, intermediates and finished products on behalf of its customers. Scaling-up tests, product transfers and the manufacture and packaging of clinical batches remain part of its enhanced portfolio.
The firm added a new high-volume production line for large-scale tablet manufacturing at its Tittmoning site in Germany last month, which increases the company’s production capacity by around two billion tablets a year.