Unolab

What Unolab does

Unolab Manufacturing S.L. is a privately held Spanish contract development and manufacturing organization (CDMO) founded in 2008 and headquartered in Getafe, Madrid, that specializes exclusively in sterile unit-dose liquid formulations produced via Blow-Fill-Seal (BFS) technology on Bottelpack® equipment. The company operates from a single consolidated 18,000 m² facility running 8 BFS production lines with annual capacity exceeding 600 million unit-doses across more than 50 validated formats ranging from 0.4 mL to 10 mL, primarily serving ophthalmic (saline, buffered saline, hyaluronic-acid-based wetting solutions) and respiratory (isotonic and hypertonic saline for nebulization) applications, plus nasal irrigation products. Regulatory coverage spans GMP, ISO 13485, CE marking, ANVISA accreditation for Brazil, and a recently completed EU GMP Annex 1 Grade A retrofit in its new Manufacturing Room III.

The commercial model is a pure CDMO play: Unolab generates revenue from contract aseptic manufacturing fees, technology transfer of client products into BFS, professional R&D services (formulation, analytical method validation, ICH stability studies, regulatory dossiers), out-licensing of CE-marked drug dossiers and medical devices to private-label distribution partners in over 30 countries, and integrated logistics through a 2,470-pallet automated silo warehouse. Pricing is quote-based and not publicly disclosed; go-to-market is enterprise field sales supported by participation in approximately a dozen international pharmaceutical, ophthalmology and respiratory trade shows (CPhI, Arab Health, ESCRS, Vitafoods, EuroPLx, PLMA, SOE among others).

The company is led by founder and General Manager Beatriz López Besga, employs more than 175 people as of 2024, and is privately funded with a 2024 grant from Spain's CDTi for technological innovation equipment and ongoing capex to expand the Getafe footprint. It explicitly does not commercialize its own branded products, preserving customer neutrality in a regulatory-heavy industry where conflict-free manufacturing is a procurement criterion for many pharmaceutical and medical-device sponsors.

Name

Unolab

Legal name

Unolab Manufacturing S.L.

Website

https://unolab.es

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

51–100 employees

Short description

Unolab is a privately held Spanish CDMO specializing exclusively in sterile unit-dose liquid formulations manufactured via Blow-Fill-Seal technology, serving pharmaceutical and medical-device clients worldwide with ophthalmic and respiratory products distributed in over 30 countries.

Ownership category

akta.pro rank

Product category

Pharmaceutical Contract Manufacturing (CDMO)

NAICS

Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Sterile Fill-Finish & Aseptic Manufacturing CDMO (HLAGABAH)

akta.pro secondary industries

Packaging, Labeling & Serialization (Clinical/Commercial) CDMO (HLAGABAJ), Drug Substance–Drug Product Integrated CDMO (HLAGABAG)

Keywords

• Sterile unit-dose manufacturing
• Blow-fill-seal technology
• Contract pharmaceutical manufacturing
• Aseptic manufacturing services
• CDMO services

Headquarters

HQ city

Madrid

HQ country

Spain

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Supply Chain

Revenue model

1. Contract Manufacturing (CMO): Aseptic manufacturing of sterile unit-doses for pharmaceutical and medical device companies. Revenue generated through manufacturing fees based on production volume, batch size, and complexity. Supports both small-scale clinical trial batches and large-scale industrial production.
2. Research & Product Development Services: Full-service R&D including formulation development, analytical method development and validation, compatibility studies, ICH stability studies, clinical batch supply, and technical documentation for regulatory submissions (IMPD, technical dossier, eCTD).
3. Technology Transfer: Transfer of client products into BFS manufacturing environment including documentation study, equipment compatibility assessment, process parameter definition, analytical method transfer, risk assessments (nitrosamines, ICH Q3D), and validation batches.
4. Out-Licensing: Licensing of ready-made drug dossiers and CE-marked medical devices to partners for private label distribution. Includes manufacturing, regulatory documentation, and packaging customized to partner branding. Products distributed in over 30 countries.
5. Logistics Services: Integrated logistics including warehouse management, order preparation, and distribution with full traceability from order creation to final product release.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core offering

Unolab is a pure CDMO that manufactures sterile unit-dose liquid formulations using Blow-Fill-Seal (BFS) aseptic technology for pharmaceutical and medical device companies. It provides end-to-end services spanning research and product development, technology transfer, aseptic manufacturing, secondary packaging and serialization, logistics, and out-licensing, with production focused on ophthalmic, respiratory, and nasal application sterile unit-dose products.

Product overview

Unolab is a global CDMO (Contract Development and Manufacturing Organization) specializing in the development and manufacturing of sterile single-dose liquid formulations using Blow-Fill-Seal (BFS) technology. The company operates exclusively with BFS technology, offering a comprehensive suite of services including Research & Product Development, Technology Transfer, Out-Licensing of drug dossiers and CE-marked medical devices, Aseptic Manufacturing, and Logistics. Unolab focuses primarily on ophthalmic (eye drops, wetting solutions) and respiratory (inhalation/nebulization solutions) therapeutic areas, producing unit-doses ranging from 0.4 mL to 10 mL. The company also provides secondary packaging with serialization capabilities for regulatory compliance.

Differentiator

Problem solved

Functional benefit

Products and services

• Aseptic Manufacturing Services (Blow-Fill-Seal) Contract aseptic manufacturing of sterile unit-dose liquid pharmaceutical products using Blow-Fill-Seal technology, supplied to pharmaceutical and medical device companies in ophthalmic and respiratory therapeutic areas.
• Research & Product Development Pharmaceutical R&D and formulation development service for sterile unit-dose ophthalmic, respiratory, and nasal products, supporting clients from early development through process design.
• Technology Transfer Process transfer service that moves clients' existing sterile liquid product formulations and validated processes onto Unolab's BFS aseptic manufacturing platform.
• Secondary Packaging & Serialization Automated secondary packaging and serialization of sterile unit-dose products, providing unit-level traceability and finished-product format ready for distribution.
• Logistics Services Outbound logistics and distribution service for finished sterile unit-dose pharmaceutical products manufactured at Unolab's Murcia facility.
• Out-Licensing of Formulations Licensing service under which Unolab out-licenses its registered sterile unit-dose formulations to third-party partners for commercialization in specific territories or channels.

Quantifiable outcome

• Up to 600 million unit-dose products per year capacity
• +3 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

One partnership is on record.

• International Research Institutions and UniversitiesminorStrategic or Co-development PartnerCollaborations with international research institutions and universities for continuous monitoring of global trends and innovations in pharmaceutical and medical device industries.

Scale indicators9 records

Recent moves9 records

Expansion highlights6 records

Direct peers

• Stevanato Group: Italian provider of drug containment and delivery solutions, including sterile primary packaging (vials, syringes) and contract manufacturing services for injectables and ophthalmics. Comparable in serving sterile pharma primary packaging and manufacturing needs.
• Unither Pharmaceuticals: French-headquartered CDMO specializing in Blow-Fill-Seal sterile unit-dose manufacturing for ophthalmic, respiratory, and nasal applications. Closest direct competitor to Unolab, with near-identical BFS-based CDMO business model and therapeutic focus.
• Asept Pak: Malta-based BFS contract manufacturer specializing in sterile liquid formulations for pharmaceutical and medical-device customers. Highly comparable BFS-focused CDMO model serving similar ophthalmic and respiratory use cases.
• Becton, Dickinson and Company (BD Pharmaceutical Systems): Operates one of the largest BFS pharmaceutical manufacturing footprints globally through its Pharmaceutical Systems segment, producing sterile unit-dose containers and offering contract manufacturing services. Directly comparable BFS technology platform and pharma customer base.

Others

• Rommelag: German manufacturer of Bottelpack Blow-Fill-Seal equipment and operator of CMO services through its Rommelag Engineering division. Functions as both Unolab's key equipment supplier and a competitor in BFS contract manufacturing.
• AptarGroup: Global supplier of drug delivery systems and dispensing components, including sterile ophthalmic and nasal delivery devices. Adjacent to Unolab's ophthalmic and nasal unit-dose business through device and closure components.

Broad incumbents

• Recipharm: European-headquartered CDMO with sterile manufacturing capabilities serving pharma customers across multiple dosage forms including liquids and injectables. Overlaps with Unolab in sterile liquid contract manufacturing but operates at significantly larger scale and broader scope.
• Gerresheimer: European pharmaceutical packaging manufacturer (glass and plastics) with BFS capabilities acquired through Centor and Bormioli Pharma assets. Competes with Unolab in BFS primary packaging and offers integrated container-plus-filling solutions for sterile products.
• Catalent: One of the largest global CDMOs with broad sterile fill-finish capabilities across vials, syringes, and BFS formats, serving pharma and biologics customers. Competes with Unolab for ophthalmic and respiratory contract manufacturing, but offers a much wider portfolio.
• Thermo Fisher Scientific (Patheon): Global pharmaceutical services division offering sterile fill-finish, development, and manufacturing across small molecules and biologics. Competes for the same pharma CDMO budgets as Unolab but with vastly broader capabilities and geographic footprint.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/unolab
• Xx.com/unolab

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Unolab