Aenova Group, a leading international contract developer and manufacturer for the pharmaceutical and healthcare industries, presents its new sterile strategy. In the future, the focus in sterile production will be on expanding the sterile site in Latina (Italy). There, portfolio and capacities are being expanded, especially in the area of prefilled syringes (PFS) as well as intramammary syringes.

Aenova Group, a leading international contract manufacturer and developer for the pharmaceutical and healthcare industries, has launched a restructuring program for its Sterile Manufacturing business within the semi-solida and liquida business unit. This is aimed at significantly expanding capacity at the large Aenova sterile site in Latina, Italy.

Over the past 24 months, more than 20 million euros have been invested in the Latina plant to offer customers a high-performance site with state-of-the-art filling technology for sterile dosage forms, especially vials and PFS. This new manufacturing area has already been approved by the Italian authorities. Follow-on investments of approximately 15 million euros are currently underway to further expand the offering. This is mainly aimed at increasing capacity for prefilled syringes (PFS).

This is Aenova's response to the market demand for PFS and the increased customer requirements for this fast-growing sterile dosage form. With further expansions, Aenova is also positioning itself as a service-oriented end-to-end provider in this area.

In the course of this concentration, consequences will be drawn at Aenova's other sterile sites, as a comprehensive reorganization of the sites is not economically feasible, in particular due to the additional regulatory requirements for sterile production that are now coming into force. Therefore, the site in Wolfratshausen, Haupt Pharma Wolfratshausen GmbH, will be closed in 2023 and the sterile manufacturing sub-segment at the Gronau site, Haupt Pharma Wülfing GmbH, will be discontinued. Customer projects should be transferred or completed according to plan.

At the Gronau site, the focus in the future will be on the successful solida business with capacity expansions already being implemented.

"Our restructuring and focus on our Latina sterile site is targeting a growth market. This pays off for the entire Aenova strategy. It puts us in an excellent position for the future," explains Jan Kengelbach, CEO of the Aenova Group.