Unither Pharmaceuticals was established in Amiens, France, in 1993 with a clear vision: to make affordable healthcare solutions that improve and simplify patients’ lives for as many people as possible. With 30 years of experience and constant innovation, Unither has established itself as a world-leading contract development and manufacturing organization (CDMO) of pharmaceutical products.
The CDMO specialises in the development and manufacturing of liquid forms (particularly eye drops, saline solutions, and asthma medications in Blow-Fill-Seal (BFS) unit doses and OTC and Rx formulations in stick-packs) for pharmaceutical companies and generic manufacturers.
Currently employing more than 2000 people in 8 manufacturing plants in France, the United States, Brazil and China, Unither Pharmaceuticals achieved sales of €371 million in 2022. Among their business models are contract development and manufacturing from preclinical to commercial, co-development with their customers, and turnkey product development.
Blow-Fill-Seal worldwide leader
Unither is the worldwide leader in sterile unit-dose production using Blow-fill-seal (BFS) technology. Thanks to its constant and sustained investment in new high-speed BFS lines, their large manufacturing capacity (5 billion doses/year) allows them to take on new projects of any size at any time.
BFS consists of forming, filling and sealing the unit dose in a single manufacturing step. Pharmaceutical grade low density polyethylene (PE) is stored in granular form in silos outside the building. The PE is transported to the BFS packaging lines. It is then heated in extrusion screws to 220-230°C and blown into the molds of the BFS machine. The bottom part of the unit dose is formed.
Needles are then filled with the drug before a new PE blowing step to form the upper part of the package and seal the container. A few seconds are enough to create and fill a strip or gob of 10 doses attached to each other. All these operations allow to obtain a perfectly sterile product. The drug undergoes two filtrations, one of which is sterilizing before filling. And the BFS steps take place under a sterile air shower. The medication in the unit-dose is therefore sterile by construction.
As a pure-player CDMO, their mission is to deliver innovative, sustainable and competitive solutions to their customers. Their expertise includes an extensive range of unit dose and multidose packaging, such as Blow-fill-seal (BFS) and stick-packs, but also preservative-free multidose, pharmaceutical bottles, sprays, tablets, tubes, suppositories and pessaries.
Liquid products can be manufactured in Europe, North and South America and Asia at the same time, which guarantees adaptability to meet demand on all 4 continents. Production lines in France, the USA, Brazil and China are regularly inspected by their regulatory authorities to ensure our products’ compliance and processes. They are approved by the European Agency, FDA, ANVISA, Korean, and Chinese Ministry of Health as well as many others.
Innovation is part of the group’s philosophy. In other words, they provide all the elements their customers need to meet their immediate needs as well as develop a long-term strategy with them.
From early works to commercial manufacturing
Unither’s teams handle the technology transfer of products developed by our customers or third parties. They can also handle the complete development of customised drugs or medical devices. Thanks to its dedicated and highly qualified on-site R&D teams and specific pilot workshops, Unither has the know-how, equipment and expertise to manage product development from the earliest stages.
Their services include:
- Clinical batches: ICH stability (registration and tracking of clinical batches), Phase II and III cGMP clinical batches (variable batch size)
- Analytical development: ICH stability (pre-stability, development, clinical batches), analytical services: development, validation and quality control
- Industrial transfer: Scale up and validation of manufacturing processes, cGMP batches (pre-industrial and industrial scale)
- Production of commercial batches: process formulation and implementation for drugs and medical devices
- Regulatory support: the drafting of IMPD/INDs, MA files (module 2.3 and 3) and technical files for medical devices (manufacturing part), pharmaceutical variations, and answers to pharmaceutical questions from the authorities.
Our know-how applies to an extensive range of applications, such as buccal health, cold and flu remedies, gastroenterology, ophthalmology, pain management, respiratory disease, rhinology, gynecology and wound management. In addition to our manufacturing capabilities, we also offer a range of services to support orphan drug development and commercialization.
Innovative ophthalmological products
Unither’s industrial engineering offers 3 main technologies for sterile manufacturing of ophthalmic products: Blow-Fill-Seal (BFS) in single unit vials, Preservative-free multidose (PFMD) and common Multidose (MD) for products with preservatives. Always looking for innovative solutions to meet their customers’ requirements and patiens’ needs, they built an industrial synergy between two main technologies for PF (preservative-free) ophthalmic products BFS & PFMD, providing their customer with sustainable solutions and the patients with tailored products to facilitate their life.
Among many others, artificial tears, ocular hygiene solutions, anti-infective and anti-inflammatory treatments are now available in PFMD version along with BFS presentation. The list of molecules fitting with the PFMD presentation is growing: prostaglandins, immunosuppressants, different combinations of API allowing to treat chronic and punctual/ seasonal diseases like glaucoma, conjunctivitis, uveitis, DES (Dry eye syndrome)… but also certain preparations for ophthalmological examinations.
Multidose packaging benefits go beyond convenience, hygiene and tolerance optimization. This sustainable and affordable technology is easy to carry, and it is designed to be reusable (easy to recap). The preservative-free multidoses are manufactured in a sterile and preservative-free environment to limit microbial contamination every time the product is poured. This grants patients a safe product that can be used up to 30 days.
If required, some works can be provided by or executed with the participation of our innovation & development centre in Bordeaux or the back-up manufacturing plant.
At the core of their operations is a commitment to sustainability that aims at minimizing their environmental impact. They actively implement sustainable practices throughout their processes, including the LDPE reuse and recycling.