Filling your vision, from formulation to commercial supply.
Hyteka is a full-service Contract Development and Manufacturing Organization headquartered in San Marco di Castellabate, Italy. We combine six decades of pharmaceutical heritage with Industry 4.0 automated filling to deliver tech-transfer and manufacturing for sterile injectables and ophthalmic medical devices.
Italian manufacturing heritage. Industry 4.0 production.
As part of the Alfa Intes group, Hyteka combines six decades of pharmaceutical heritage with state-of-the-art automated filling technologies to deliver tech-transfer and advanced manufacturing for injectables.
We pair Italian manufacturing heritage, Industry 4.0 production lines, and a regulatory infrastructure aligned with international standards — bringing partners to market with speed, quality and confidence.
Two manufacturing plants in Italy, 20,000 m² combined, running 4,000–10,000 units/hour across 4 dedicated cleaning rooms.
Two dedicated manufacturing sites, one continuous flow.
Plant 2 brings total fill-finish capacity to 10,000 units/hour and extends batch sizes to 40 L, positioning Hyteka for global-scale partnerships.
Plant 1
Operational since 2021Plant 2
Operational since 2027Dosage forms & container formats
Pre-filled syringes (PFS)
- Glass type I
- Bromobutyl stopper
- Finger-flange plunger rod
Injectable vials
- Glass type I
- Rubber stopper
- Aluminium crimp cap
Production flow
Five macro-phases, vertically integrated — engineered to mitigate particulate and microbiological cross-contamination.
Pure steam & WFI production
All filling, sterilisation and wash operations use Water for Injection from a dedicated closed-loop system, continuously monitored to Pharmacopoeia requirements. Pure steam supports all autoclave cycles.
Aseptic filling
Automated aseptic fill-finish in Class A GMP (ISO 5) isolator environments with continuous monitoring. High-precision pumps are calibrated for non-Newtonian, high-viscosity fluids, engineered to eliminate micro-bubbles — critical for intraocular products.
Sterilisation
Validated moist-heat sterilisation (steam autoclave) cycles developed to ISO 17665, optimised for full microbiological inactivation while minimising thermal stress on the polymer chain.
Automated optical inspection
100% automated inspection on every unit, across seven critical quality parameters:
- 01Filling volume accuracy
- 02Suspended particles
- 03Flange integrity
- 04Solution colour conformance
- 05Stopper traces & residues
- 06Plunger integrity
- 07Stopper positioning
Automated release records, batch-level traceability.
Secondary packaging & serialisation
Modular automated lines in one continuous flow: cartoning, labelling, leaflet insertion, tamper-evident sealing, blister packaging and aggregation. Full serialisation and track-and-trace, compliant with EU FMD.
Three ways to partner, one continuous relationship.
Whatever you bring to the table — a finished formulation, a Technical File, or only a concept — our teams work as an extension of yours across the stages that matter.
Private labelling
CE-marked OVDs (ocular viscoelastics), viscoelastics and surgical dyes, ready to brand and sell under your label. CE-marked under MDR EU 2017/745. No R&D investment — the shortest route to market.
No R&D requiredContract manufacturing
Combination of external formulation and Technical File assets with comprehensive on-site capabilities. End-to-end tech-transfer support guides the transition, enabling scalable progression from pilot batches to commercial volumes.
You bring the formulationContract development & manufacturing
Full end-to-end partnership — from formulation concept through scale-up and regulatory filing to commercial supply. Our R&D and regulatory teams work as an extension of yours.
You bring the conceptWho does what, by model
| Model | IP | Development | Manufacturing | Supply |
|---|---|---|---|---|
| Private labelling | Hyteka | Hyteka | Hyteka | Hyteka |
| Contract manufacturing | Your brand | Your brand | Hyteka | Hyteka |
| Contract development & manufacturing | Your brand | Hyteka | Hyteka | Hyteka |
Private labelling
Contract manufacturing
Contract development & manufacturing
Development, regulatory and quality — under one roof.
Five capability areas support partners across the full product lifecycle, from feasibility through commercial-scale production.
Development services
From formulation concept to commercial supply — every protocol is designed for the specific challenges of injectable products, across four validated stages.
Formulation & feasibility
Raw material selection, rheology characterisation, lab-scale trials.
Process development & scale-up
Tech-transfer to Class A lines, pilot batches, filling parameter tuning.
Validation & registration
Process validation (IQ/OQ/PQ), ICH-compliant stability, Technical File and dossier authoring.
Commercial supply
Serialised batch release, secondary packaging, qualified global logistics.
Regulatory affairs support
Documentation and strategy across EU and major international markets
Regulatory affairs support
Analytical development & quality control
ICH-compliant characterisation, release testing and stability programmes
Analytical development & quality control
Analytical development
Quality control & stability
Quality management system
The operational backbone of our facility — not an audit-layer
Quality management system
Operational backbone — PDCA cycle
Certifications & compliance
IVDR EU 2017/746 requirements are additionally applied where relevant to related in-vitro diagnostic business lines.
Supply chain
A qualified, globally connected sourcing network
Supply chain
Hyteka operates a qualified, globally connected supply chain for APIs, excipients, and primary packaging components — access to a pool of trusted, pharmaceutical-grade raw material suppliers, pre-qualified under our QMS.
- Hyaluronic acid APIs & excipients
- Primary packaging
- Pre-qualified suppliers
- Dual-sourced critical materials
- Incoming QC & endotoxin testing on every lot
- Managed lead-time & buffer stock
Ready-to-market ophthalmic devices, ready for your brand.
All Hyteka OVDs are CE-marked under MDR EU 2017/745 and available for private labelling — ready to be sold under your brand in EU and non-EU markets, once locally registered.
High molecular weight hyaluronic acid, mastered.
Polymers beyond 2.5 million Daltons carry exceptional viscoelastic and biocompatible properties — and exceptional manufacturing risk. Our protocols are built around the chain, not against it.
Non-degradative solubilisation
Calibrated mixing temperature and speed fully hydrate the polymer without the shear degradation that would fragment the chain.
Pseudoplastic rheology
High viscosity at rest protects the corneal endothelium; under pressure, the gel turns fluid — lowering the extrusion force needed at injection.
Class A aseptic filling
Chains above 2.5 MDa are thermolabile. We sterile-filter and fill in Class A (ISO 5) cleanrooms — no terminal heat to collapse viscosity.
Total batch screening
Molecular weight, viscosity, syringe-ability, endotoxin and bioburden verified on every lot — guarding against Toxic Anterior Segment Syndrome.
Engineered from an ultra-pure sodium hyaluronate matrix, 2.5–3.5 MDa.
Cohesive control
- Moves as a single mass
- Maintains cohesive integrity during active fluidics
- Rapid and efficient removal
- Excellent for final surgical steps
Balanced performance
- Enhanced chamber stability
- Balanced handling and protection
- Greater structural control
- Broad procedural versatility
Viscoadaptive expression
- Exceptional chamber stability
- Cohesive-dispersive response under surgical fluids
- Broader corneal endothelial coverage
- Pronounced elasticity
OVD Premium with taurine
A 1.8% viscoadaptive formulation built on the same ultra-pure HA platform and enhanced with taurine, a naturally occurring amino acid widely present in ocular tissues.
Under surgical fluidics, its cohesive-dispersive response supports controlled redistribution while preserving chamber stability, surgical control and efficient removal.
One premium formulation. A distinctive story for your brand.
Trypan Blue 0.06%, completing the surgical set
The gold-standard vital dye for anterior capsule staining, providing high-contrast visualisation of the capsule boundary — critical in mature and white cataracts where the red reflex is absent. Available in both vial and pre-filled syringe format.
Innovation roadmap, 2027–2028.
Every pipeline category maintains a private labelling structure — full brand exclusivity for distribution partners.
- Blue-dyed OVD
- Ultra-viscous HA 2.5% & 3.0%
- Lidocaine-enhanced OVD
Your brand on our devices.
Full-colour printed cartons and pre-filled syringe labels carrying your logo, concentration and volume — backed by Hyteka's manufacturing excellence and CE-marking infrastructure.
- CE-marked & ready
- Regulatory support
- Customisable packaging
- Scalable volumes
- Serialisation included
- Brand exclusivity options
CE-marked & ready
No additional R&D investment. Sell in EU and non-EU markets upon local registration.
Regulatory support
Technical Files, Declarations of Conformity, and dossier authoring for non-EU registration.
Fully customisable packaging
Label, carton, colour scheme and regulatory text adapted to your brand.
Scalable volumes
From market-entry quantities to full commercial scale — no partner change required as you grow.
Serialisation included
Track-and-trace and aggregation compliant with international supply chain requirements, standard in every order.
Brand exclusivity options
Exclusive geographic arrangements available to protect your market positioning.
"Your brand. Our expertise. One partnership."
Built to certification, not toward it.
- MDR EU 2017/745Design & manufacturing of injectable ophthalmic medical devices
- ISO 13485Quality management for medical devices
- ISO 9001General quality management
- ISO 17665Sterilization — moist heat (steam)
Trusted by partners who need it done exactly their way.
Partners choose Hyteka because flexibility is part of the foundation, not an afterthought. From formulation and concentration to container format, label and carton, each element can be shaped around your brand and specification. Batch sizes can also adapt to the pace of your launch, supporting smaller start-up runs as well as larger commercial volumes, while automated aseptic filling in a Class A (ISO 5) environment keeps every step precise, traceable and consistently controlled.
Partnering to fill the future.
Whether you are a distributor looking for a ready-to-brand OVD portfolio, or a pharmaceutical company seeking a dedicated ophthalmic CDMO partner, Hyteka is ready to discuss your specific needs.
Enquiry received.
Our partnerships team will respond within two business days. In the meantime, feel free to explore the private label portfolio above.