Aenova Introduces New Sterile Strategy


Aenova Group, a leading international contract manufacturer and developer for the pharmaceutical and healthcare industries, has recently 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.

Significant capacity expansions at Aenova steril’s Latina site for fill & finish vials and prefilled syringes (so-called PFS) (Photo: Aenova).

The Aenova Group is a leading global contract manufacturer and development service provider for the pharmaceutical and healthcare industry. As a one-stop store, Aenova develops, produces and packages all common dosage forms, product groups and active ingredient classes from pharmaceuticals to dietary supplements for human and animal health: solid, semi-solid and liquid, sterile and non-sterile, high and low dose, OEB 1 to 5 (Occupational Exposure Band). Approximately 4,200 employees at 16 sites in Europe and the US contribute to the company’s success. For more information, visit www.aenova-group.com.

Contact for inquiries:

Dr. Susanne Knabe
Head of Communication & PR
Aenova Holding GmbH
Berger Straße 8-10
D-82319 Starnberg
Tel: +49 8151 9987-135
Mobile: +49 170 22 368 42
E-mail: susanne.knabe@aenova-group.com