Author: Eric Chesnel, Commercial & Licensing Director at Unither Pharmaceuticals – published in Pharmanetwork magazine

Created in 1993, Unither Pharmaceuticals is a French CDMO dedicated to health products and specialised in sterile single doses and non-sterile liquids. It supplies the main global markets from a unique industrial network of eight factories spread across four continents – North America, South America, Europe and Asia – and an R&D centre of expertise mainly on the formulation of ophthalmic products based in Bordeaux in France. Unither Pharmaceuticals has a turnover of €500m and a workforce of 2,200 people.

As world leader in BFS with more than five billion doses manufactured per year, it serves the ophthalmology, asthma, and rhinology markets. It also has unique know-how in liquid sticks. Since the end of 2021, demand from our customers has increased significantly and, despite regular capacity investments, we are now reaching the limit of our delivery possibilities.

Unither is spending more than €80m in 2023

In this context, and to support the growth of our customers, significant investments will be undertaken on almost all of our sites. Unither is spending more than €80m this year and the amount for 2024 is expected to be significantly higher.

The ophthalmology market remains very dynamic and its internationalisation is increasing every day. To respond to this, Unither offers a unique network of five factories spread across four continents: Amiens and Coutances in France, Butanta in Brazil, Nanjing in China, and Rochester (New York State) in the United States.

The implementation of the first preservative-free multi-dose line within the Group will be operational at the start of 2024 on our Coutances site. It has the possibility of hosting a double technical solution with the pump systems developed by Némèra and Aptar. This flexibility for our customers will allow us to respond to a wide diversity of products for various destinations – the Coutances site being, among other things, approved by the FDA.

The Butanta site specialising in multi-doses with preservatives will also be able to adapt to this booming market, subject to adaptations.

In addition, BFS capacity is increasing on the Amiens sites with the arrival of a second line, and in Coutances, Nanjing and Rochester with the arrival of one to two lines per site. In total, more than 16 Rommelag 460 lines will be operational next year. Despite this deployment, we are aware that next year will remain a big logistical challenge to serve our customers. The teams will once again be strongly mobilised to provide the best answers in coordination with our customers.

A substantial investment plan is being prepared to support demand for both single-dose and multi-dose. Decisions are underway for deployment over the years 2025 to 2027.

On our Gannat site (France), which is mainly dedicated to the manufacture of physiological serum, we started the BFS N°7 line in September. The next one will be installed at the start of the second quarter of 2024. The site is preparing to receive new lines, at least two of which will be installed from 2025. Then by 2026, the site will once again be able to receive new facilities to anticipate the needs.

To give visibility to our customers

These lines will make it possible to respond to different demands whether in France, Europe or export. Beyond that, the site has land reserves allowing it to be extended, which can give visibility to our customers.

Furthermore, in the first half of 2024, the Amiens site will implement two new BFS lines; one dedicated to the asthma format (2-4ml) and a second in 10ml format. In both cases, we will have the possibility of securing existing production by offering internal back-up, and also of responding to new requests.

As for the site in Colomiers, France, which specialises in non-sterile liquids (bottles, liquid sticks and sprays), it will benefit from very significant investments for its expansion. After two years of very strong growth, the site has also reached a capacity limit. The work, which will begin at the very beginning of the year, will aim to significantly expand the site to install a finished products store in line with the new production volumes, extend the preparatory to accommodate new tanks, and prepare the arrival of new filling and packaging lines.

At the same time, synergies with the site in Barretos, Brazil, which is also dedicated to these same forms, will increase. And the latter will also benefit from capacity investments to accommodate commercial production from 2025.

CSR ambitions to reduce the environmental impact

By offering a double mesh for sterile or non-sterile liquids, Unither provides prospects and its customers with unique expertise in the management of inter-site transfers and the possibility of manufacturing as close as possible to end markets. This industrial strategy, defined for many years, is completely in line with our CSR ambitions to reduce the environmental impact in the manufacturing of medicines for us and for our customers.