Manufacturing technologies & pharmaceutical solutions

Unither Pharmaceuticals offers a wide range of pharmaceutical manufacturing and packaging technologies: Blow-Fill-Seal (BFS), preservative-free multi-dose products, liquid stick packs, vials and sprays, tablets and capsules, and suppositories and pessaries. Ophthalmic drugs, asthma treatments, analgesics, vitamins and food supplements, products for headaches, colds, coughs, or digestive disorders… our single-dose or multi-dose technologies can be adapted to multiple applications to facilitate patient compliance.

The Added Value for Your Projects

Manufacturing Expertise

BFS production (14)

Global leader in Blow-Fill-Seal

Unither Pharmaceuticals is currently the world leader in sterile single doses, with a production capacity of over 5 billion doses per year. Twenty years ago, single-dose packaging was still just a new dosage form; it has now become the standard in therapeutic areas such as ophtalmology and ENT, driven by changes in medical practices, treatments, and patient needs.

Leveraging our extensive experience in the development and production of single-doses, we support our clients from the transfer of existing products to the creation of customized solutions that are safe, compliant, and adapted to clinical uses and global markets.

The added value for your projects

Large-volume manufacturing

High-speed industrial production, with a secure supply chain. Our 9 global sites and backup facilities ensure reliability, continuity, and on-time delivery.

Small batches & orphan drugs

Expertise dedicated to low volumes: flexible, controlled, and secure production to meet the specific needs of rare diseases and niche markets.

Life-cycle management

We continuously optimize formulations and processes to extend product shelf life, reduce costs, and enhance performance, while complying with regulatory requirements.

Scale-up & technology transfer

We secure the transition from laboratory to industrialization: scale-up, process validation, and reproducibility to ensure industrial performance and compliance.

Specialists in liquid pharmaceutical forms

We master the manufacturing of sterile and non-sterile liquid forms: BFS unit-doses, vials, sprays, and stick packs, for ophthalmology, ENT, respiratory care, and OTC, with high quality standards.

End-to-end support from the initial phases: from concept to product

Manufacturing

From technology transfer to industrial manufacturing, from small clinical batches to commercial volumes.

Development

Formulation and analytical development, manufacture of clinical batches, stability studies, and expertise in ophthalmic development.

Out-licensing

Access medicines and medical devices that are ready to be registered and marketed.

Quality commitments and regulatory compliance

Colomiers

Our production sites in France, the USA, Brazil, and China are regularly inspected and approved by the main international health authorities: EMA, FDA/DEA, Health Canada, ANSM/ANSES, ANVISA, MHRA, MFDS, TGA, NMPA (China GMP), as well as by many other agencies (Turkey, Russia, Colombia, Peru, Pakistan, etc.). Several sites are authorized to manufacture certified sterile and non-sterile products for medical devices.

Our activities are carried out in strict compliance with cGMP in Europe, the USA, Brazil, and China, as well as with standard ISO 13485:2016 (GMED/LNE). We use certified asceptic processes, controlled stability programmes that comply with ICH/OMS quidelines, and some units a certified ISO 50001 compliant. In France, our sites also benefit from the Research Tax Credit (Crédit d’Impôt de Recherche).

Expertise tailored to your therapeutic areas

Do you have any questions? - Consult our FAQ

Low volumes demand significant industrial flexibility, equipment tailored for small batches, stringent quality control, and agile logistics. Each batch must be meticulously designed, as it often addresses a highly targeted and vital need. We assist our clients with formulation development, clinical batch manufacturing (phases I to III), and industrial transfer to commercial production.

Blow-Fill-Seal (BFS) technology forms, fills, and seals the container in a single step, using a fully aseptic process with no direct human intervention, in a fully controlled environment. Our lines are suitable for preservative-free products and operate in compliance with international GMP (EU, FDA, ANVISA, NMPA).

BFS is a closed aseptic process that is ideal for sterile single doses and is particularly suited to sensitive formulations. As a global leader in BFS, Unither guarantees optimal sterility, high reproducibility, and safe, preservative-free eye drops that comply with international standards.

Yes. The Blow-Fill-Seal (BFS) process is recognized by major international health authorities, including the FDA (U.S.) and the EMA (Europe). It has been used for decades in the production of sterile drugs, medical devices, and vaccines. It guarantees a high level of sterility, achieved through complete process automation and the absence of preservatives, and meets the most stringent regulatory standards. This makes it a key process for laboratories seeking to ensure safety and compliance.

Our patented Sol-Gel™ technology allows the formulation of liquid ophthalmic hydrogels for production, which gel upon contact with tear fluid thanks to gellan gum. This property increases patient comfort, prolongs drug release time, and offers high bioavailability. Sol-Gel™ requires less active ingredient than traditional eye drops, which limits adverse effects. The first application, Solmyd™, offers effective mydriasis in a single instillation, instead of several successive drops.