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Pharmaceutical

Leading CDMO Companies in Ireland: Your Complete Guide to Contract Manufacturing in 2026

Sreepriya Prasannan
Sreepriya Prasannan
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Leading CDMO Companies in Ireland: Your Complete Guide to Contract Manufacturing in 2026

Ireland has quietly become one of the most important addresses in global pharmaceutical manufacturing. The island is the world's third-largest exporter of pharmaceuticals by value, with annual exports exceeding €100 billion, and nine of the world's ten largest drug companies operate significant facilities here. At the heart of this success is a thriving network of Contract Development and Manufacturing Organizations - CDMOs - that serve global pharma and biotech sponsors across every stage of the drug lifecycle, from early API synthesis through to commercial packaging and distribution.

This guide profiles the nine most significant CDMO companies operating in Ireland in 2026, drawing on verified facility data, recent expansion announcements, and regulatory records. Whether you are scouting an API synthesis partner, a high-potency oral solid dose manufacturer, a cell-therapy CDMO, or a clinical packaging specialist, Ireland's contract manufacturing ecosystem covers it all.


Ireland as a CDMO Hub

Why Pharma Companies Choose Ireland for Contract Manufacturing

Ireland offers a rare combination of regulatory credibility, scientific talent, and strategic geography that few countries can match:

Dual FDA & EMA Approval Ireland-based facilities routinely hold both US FDA and EU EMA approval, enabling global supply from a single site.
80,000+ Life Science Jobs Seven of Ireland's eight universities offer pharma-aligned science and engineering programmes, feeding one of Europe's deepest life science talent pools.
12.5% Corporation Tax Rate Combined with the Knowledge Development Box (6.25% on IP income) and IDA Ireland R&D grants covering 45–50% of project costs.
Only English-Speaking EU Nation Seamless access to 450 million European consumers with simplified regulatory submissions, labelling, and supply chain logistics.
World-Class Infrastructure Government committed €216 billion to national infrastructure 2025–2035, including utilities, logistics, and energy networks directly supporting industry.
9 of Top 10 Global Pharma Present Ireland ranks third globally for pharma exports. The critical mass of multinational operations means unrivalled supply chain depth and shared regulatory expertise.

The Top CDMO Companies in Ireland: Full Profiles

The following nine companies represent the most established and well-resourced Contract Development and Manufacturing Organizations with active facilities in Ireland. Each profile covers location, primary specializations, regulatory certifications, facility footprint, and key recent developments.

HV

01 · API Manufacturing · Spray Drying · Particle Engineering

Hovione - Ringaskiddy, County Cork

Ringaskiddy, Cork · hovione.com

API Manufacturing Spray Drying Inhalation Powders Amorphous Solid Dispersion 24/7 Operations

Hovione is a globally recognized independent CDMO and the world leader in spray drying for pharmaceutical applications - a technology critical for inhalable therapies and oral drugs with low bioavailability. Founded in Lisbon in 1959 and now operating across four continents, Hovione's Cork facility is housed at the former Pfizer Lipitor API plant in Ringaskiddy, acquired by Hovione in 2008.

The site specializes in integrated API synthesis, particle design, and pharmaceutical formulation development and manufacturing. The facility runs 24 hours a day, seven days a week, with quality control laboratories providing continuous analytical support. In recent years Hovione has made multi-million-euro investments to nearly double its spray drying capacity in Cork, reinforcing the site as its European centre of excellence for spray drying. A new Process R&D group expansion was completed in 2024, alongside a highly potent small-scale equipment suite to support clinical and registration campaigns.

The Ringaskiddy site handles APIs up to OEB 4 potency class and supports organic solvents. The spray drying platform is supplied by Büchi and GEA, enabling production of both amorphous solid dispersions for oral drugs and dry powders for inhalation.

Location

Ringaskiddy, Cork

Operations

24/7 Continuous

Potency Handling

Up to OEB 4

Parent

Hovione (Private)

Equipment

Büchi + GEA Dryers

Global Sites

US · Portugal · China · IE

FDA Approved EMA EU GMP ICH Compliant OEB 4 Containment
hovione.com ↗
TF

02 · API Drug Substance · Process Chemistry · Analytical Development

Thermo Fisher Scientific (Patheon) - Ringaskiddy, Cork

Ringaskiddy, County Cork · patheon.com

API Drug Substance Process Chemistry Analytical Development Complex Small Molecules 500+ Employees

Thermo Fisher Scientific's Cork site - operating under the Patheon CDMO brand - is one of Ireland's largest and most technically sophisticated API contract development and manufacturing facilities. The site was acquired from GlaxoSmithKline (GSK) in 2019 for approximately €90 million, and since that transfer, the plant has increased its manufacturing capacity fivefold, now servicing over 20 global pharmaceutical customers.

Located in Ringaskiddy, County Cork, the facility employs over 500 highly skilled chemists, engineers, analysts, and manufacturing operators. A sister analytical and laboratory services site in Athlone employs a further 400. The site has a 45-year manufacturing heritage, originally supplying GSK's global API portfolio and now supporting a broad range of innovative therapies.

The site specializes in complex small molecule APIs, with a particular focus on treatments for childhood cancer, Parkinson's disease, and depression - compounds requiring exacting chemistry control and multi-step synthetic routes. Thermo Fisher Cork supports customers from early-phase process development through commercial API supply, while the Athlone facility provides stability testing and method development services.

Employees (Cork)

500+

Acquisition Cost

€90M (from GSK)

Capacity Growth

5× since 2019

Customers

20+ Global Pharma

Heritage

45 Years on Site

Sister Site

Athlone (Lab Svcs)

FDA Approved EMA EU GMP ICH Q10
patheon.com ↗
EG

03 · High-Potency OSD · Oncology · Softgel Capsules

EirGen Pharma - Waterford, Ireland

Waterford City, County Waterford · eirgen.com

High-Potency OSD Oncology / Cytotoxic Softgel Capsules Film-Coated Tablets Rare Diseases 120+ Partners · 60 Countries

EirGen Pharma is one of Ireland's most impressive home-grown pharmaceutical success stories. Founded in Waterford in 2005, the company has built a two-decade track record as a global leader in developing and manufacturing high-potency oral solid dose (OSD) medicines, specializing in oncology treatments, rare diseases, and cytotoxic applications for both human and veterinary use.

EirGen's Waterford campus spans 40,000 square feet of dedicated GMP manufacturing space. A major expansion is underway - a 3,500 m² high-containment manufacturing facility is scheduled to be fully operational by late 2025, designed to accommodate accelerated technology transfers and the next generation of high-potency cancer therapies.

EirGen currently produces 520 million dosage units annually, serving more than 120 pharmaceutical partners across 60 countries. By 2027, the expanded Waterford site will deliver up to 1 billion dosage units per year - a near-doubling of output driven by global demand for their specialized oncology manufacturing expertise. The portfolio spans softgel capsules, film-coated tablets, and powder or liquid-filled hard-shell capsules, all manufactured under stringent high-potency containment protocols.

Founded

2005, Waterford

Current Facility

40,000 ft² + expansion

Annual Output

520M dosage units

2027 Target

1 billion units/yr

Partners

120+ companies

Markets Served

60+ countries

FDA Approved EMA EU GMP HPRA Licensed ISO Certified
eirgen.com ↗

04 · Oral Solids · Spray Drying · Modified Release Pellets

Aenova Group (Temmler Ireland) - Killorglin, County Kerry

Killorglin, County Kerry · aenova-group.com

Oral Solid Dose Spray Drying Modified Release Pellets Amorphous Solid Dispersion ~50 Years on Site

The Aenova Group's Killorglin facility - operated as Temmler Ireland Ltd. - is one of Europe's most experienced oral solid dose contract manufacturing sites, with almost 50 years of continuous pharmaceutical operation in County Kerry. Aenova is a leading pan-European CDMO and has designated Killorglin as its Competence Center for spray drying and modified release pellets - two of the most technically demanding areas in oral drug formulation.

In early 2025, Aenova launched a significant new spray drying platform at Killorglin, equipped by Büchi and GEA, to produce amorphous solid dispersions (ASD) for oral medicines with challenging bioavailability profiles and inhalation powders. This investment addresses one of the most critical needs in modern drug development - over 90% of new drug candidates have poor water solubility, making ASD technology essential for formulating them into viable oral products.

The Killorglin facility handles APIs up to OEB 4 potency class and supports organic solvents. Its modified release pellet line encompasses granulation, modified-release coating, encapsulation, and extraction, with capabilities spanning from small development batches to full commercial-scale production.

Operating Name

Temmler Ireland Ltd.

Experience

~50 years on site

Potency

OEB 4 Rated

New Equipment

Büchi + GEA (2025)

Competence

Mod. Release Pellets

Scale

Dev → Commercial

EMA EU GMP MFDS / KFDA PMDA Japan ISO Certified
aenova-group.com ↗
HH

05 · Cell & Gene Therapy · ATMP · Sterile Manufacturing

HiTech Health - Galway, Ireland

Galway, County Galway · hitech-health.com

Cell Therapy Gene Therapy ATMP Sterile Injectables Biologics First Irish ATMP CDMO

HiTech Health holds a unique place in Ireland's life science ecosystem: it was the first Irish company to secure a manufacturing licence to produce cell and gene therapies (ATMPs - Advanced Therapy Medicinal Products) on behalf of client biotech and biopharma companies. Founded in 2013, HiTech Health is an end-to-end ATMP CDMO operating from a purpose-built GMP facility in Galway, certified by Ireland's Health Products Regulatory Authority (HPRA) and compliant with all European GMP standards.

The Galway facility was specifically designed to advance the development, manufacturing, and testing of sterile cell and gene therapy formulations, lentiviral vectors, and other advanced biologics. HiTech provides the full ATMP service spectrum: drug substance manufacturing (API), drug product formulation (FDF), research and development, and clinical trial materials production. The facility also provides batch importation and formal QP release for the EU and UK markets.

A key differentiator is HiTech Health's specialist logistics capability for time- and temperature-sensitive therapies - a critical competency in advanced therapeutics where cold chain integrity is directly tied to product efficacy and patient safety. Their regulatory affairs team supports sponsors through EMA, FDA, and HPRA approval pathways, substantially de-risking the journey from first-in-human trials to late-stage clinical supply.

Founded

2013

Specialty

ATMP / Cell & Gene

Scale

Preclinical → Phase II

Milestone

First Irish ATMP Lic.

Cold Chain

Specialist Logistics

Release

EU + UK QP Release

HPRA Licensed EMA EU GMP FDA Registered PMDA Japan
hitech-health.com ↗
PC

06 · Injectable Packaging · Drug-Device Combination · Commercial Packaging

PCI Pharma Services - Stamullen, County Meath

CityNorth Campus, Stamullen, County Meath · pci.com

Injectable Packaging Autoinjectors Pre-filled Syringes Vial Fill & Finish LEED Gold Target

PCI Pharma Services is a leading global CDMO providing integrated drug development, manufacturing, and packaging services for pharmaceutical and biotechnology companies. PCI's Irish operations are anchored at CityNorth Business Campus in Stamullen, County Meath - a strategically located site with excellent connectivity to Dublin Airport and the M1 motorway.

PCI's existing 45,000 sq ft Meath facility is being joined by a major new development: the company has signed a 25-year lease and is constructing a purpose-built 82,000 sq ft pharmaceutical packaging facility at the same campus. The new building is designed specifically for the final assembly, labelling, and packaging of injectable drug products - including vials, pre-filled syringes, and drug-device combination products such as autoinjectors and combination pen devices. These represent the fastest-growing segment in biologics packaging, driven by the surge in GLP-1 and other self-administered biologic therapies.

The new facility is targeting LEED Gold certification, an A3 Building Energy Rating, and rainwater harvesting - reflecting both client sustainability requirements and the Irish Government's green industrial policy.

New Facility

82,000 sq ft (2025)

Existing Facility

45,000 sq ft

Lease Term

25 Years

Focus

Biologics Packaging

Combined Footprint

127,000 sq ft

Sustainability

LEED Gold Target

FDA Registered EMA EU GMP HPRA Licensed ISO Certified
pci.com ↗
AL

07 · Peptide API · Commercial Manufacturing · Clinical Supply

Almac Group - Craigavon, Northern Ireland

Craigavon, County Armagh, Northern Ireland · almacgroup.com

Peptide API Commercial Drug Product Clinical Trial Supply Drug Discovery Services £65M New Facility 2025

Almac Group is one of the most comprehensive and vertically integrated CDMOs operating on the island of Ireland, with its global headquarters at Craigavon, Northern Ireland. As a fully independent, privately owned company, Almac has invested consistently across the full drug development lifecycle - from drug discovery and pre-clinical development through clinical trial supply, API manufacturing, and full commercial production.

In March 2025, Almac officially opened a new £65 million commercial manufacturing facility at Craigavon - one of the largest single pharmaceutical manufacturing investments in Northern Ireland's history. This state-of-the-art facility significantly expands Almac's capacity for complex commercial drug products, including advanced sachet presentations. A separate 32,000 sq ft facility houses new large-scale commercial manufacturing suites for this presentation format.

A particular growth area for Almac is peptide API manufacturing, one of the fastest-expanding niches in pharmaceutical outsourcing globally, driven by the GLP-1 revolution (Ozempic, Wegovy, Mounjaro) and other peptide-based therapies. A dedicated 28,000 sq ft GMP peptide synthesis and purification facility was completed in early 2025, more than doubling Almac Sciences' peptide API capacity. The facility handles synthesis, purification, and isolation for clinical development and commercial campaigns.

New Investment

£65M (2025)

Peptide Facility

28,000 sq ft GMP

Ownership

Private / Family

Scope

Full Drug Lifecycle

Sachet Facility

32,000 sq ft GMP

Opening

March 2025

FDA Approved EMA EU GMP MHRA ISO 9001
almacgroup.com ↗
WG

08 · Clinical Packaging · Distribution · Serialisation

Wasdell Group - Dundalk, County Louth

Mullagharlin, Dundalk, County Louth · wasdellgroup.com

Clinical Trial Packaging Primary Packaging Serialisation Cold Chain Distribution 90,000 sq ft · 11 Suites

Wasdell Group is a UK-headquartered contract service partner with a major Irish presence, having invested €30 million in constructing a purpose-built 90,000 sq ft GMP pharmaceutical packaging and distribution facility in Mullagharlin, Dundalk. Wasdell's Dundalk site was established to serve pharmaceutical clients requiring EU-based supply chains after Brexit - and has grown into a strategic hub for both clinical and commercial packaging in Ireland.

The Dundalk facility houses 11 production suites equipped with blister packing lines, bottle filling and capping, clinical kit assembly, and serialisation technology for EU FMD (Falsified Medicines Directive) compliance. The site also includes fully equipped QC import testing laboratories and temperature-controlled high-bay warehousing with capability from ambient through to cryogenic storage conditions.

Wasdell Dundalk holds a full Manufacturer's/Importation Authorisation (MIA) licence from Ireland's HPRA, a separate Investigational Medicinal Product (IMP) licence for clinical trial materials, and ISO 13485 certification for medical device packaging - making it one of Ireland's most comprehensively licensed contract packaging operations.

Facility

90,000 sq ft

Investment

€30 million

Production Suites

11 suites

Medical Device

ISO 13485 Certified

Serialisation

Full EU / Global

Storage Range

Ambient → Cryogenic

HPRA MIA Licensed HPRA IMP Licensed ISO 13485 FDA Registered
wasdellgroup.com ↗
CQ

09 · cGMP Stability Storage · ICH Testing · Pharmaceutical Services

Cambrex (Q1 Scientific) - Waterford, Ireland

Waterford City, County Waterford · cambrex.com / q1scientific.ie

Stability Storage ICH Zone I–IV Cryogenic Storage Biologic Stability ~40 Walk-in Chambers

Q1 Scientific - now part of the global CDMO Cambrex since its 2022 acquisition - is a specialist cGMP stability storage and testing company founded in Waterford in 2013. The Waterford facility has grown into a critical node in the European pharmaceutical stability testing network, providing environmentally controlled GMP stability storage services to pharmaceutical, medical device, and life science clients across the EU and globally.

The facility offers the complete range of ICH climatic zone conditions - from Zone I (Northern European temperate) through Zone IV (hot and very humid, required for tropical market registrations) - alongside custom temperature and humidity programs for non-standard stability protocols. The site houses nearly 40 walk-in stability storage chambers, reach-in stability units, and ultra-low temperature freezers down to -80°C for biologic drug substances and ATMP materials.

Cambrex expanded the Waterford site with an additional 10,000 sq ft following the acquisition, bringing the total footprint to approximately 30,000 sq ft. Q1 Scientific's team also provides stability program design consulting, full sample management, and regulatory-grade reporting to support IND, NDA, MAA, and other global regulatory submissions.

Founded (Q1)

2013, Waterford

Parent (since 2022)

Cambrex

Chambers

~40 walk-in units

Temp Range

-80°C to +50°C

Total Facility

~30,000 sq ft

ICH Coverage

Zones I, II, III, IV

HPRA Licensed EMA EU GMP FDA Registered ICH Q1A(R2)
cambrex.com ↗

Ireland CDMO Companies - Quick Reference Comparison

Use this table to shortlist Ireland-based CDMO partners by location, primary capability, regulatory approvals, and standout facts.

Company Location Primary Specialization Regulatory Key Highlight
Hovione Ringaskiddy, Cork API, Spray Drying, Inhalation FDA, EMA Global leader in pharma spray drying
Thermo Fisher (Patheon) Ringaskiddy, Cork API Drug Substance, Process Chemistry FDA, EMA 5× capacity since 2019; 500+ staff
EirGen Pharma Waterford High-Potency OSD, Oncology FDA, EMA, HPRA 1 billion units/year by 2027
Aenova (Killorglin) Killorglin, Kerry Oral Solids, Spray Drying, Mod. Release EMA, MFDS, ISO ~50 years on-site; EU Competence Centre
HiTech Health Galway Cell & Gene Therapy, ATMP, Biologics HPRA, EMA, FDA First Irish ATMP CDMO licence holder
PCI Pharma Services Stamullen, Meath Injectable Packaging, Drug-Device FDA, EMA, HPRA New 82,000 sq ft facility (2025)
Almac Group Craigavon, N. Ireland Peptide API, Commercial Mfg, Clinical FDA, EMA, MHRA £65M new facility opened March 2025
Wasdell Group Dundalk, Louth Clinical & Commercial Packaging HPRA MIA, FDA, ISO 13485 €30M facility; 11 production suites
Cambrex (Q1 Scientific) Waterford cGMP Stability Storage & Testing HPRA, EMA, FDA ~40 chambers; -80°C to +50°C

Choosing the Right CDMO Partner in Ireland

Ireland's CDMO landscape is one of the most diverse and capable in Europe. From world-class API manufacturers and spray drying specialists in Cork, to high-potency oral dose leaders in Waterford, pioneering cell therapy manufacturers in Galway, and comprehensively licensed clinical packaging operations in Meath and Louth - the island offers a complete range of contract manufacturing capabilities under a single regulatory umbrella.

When selecting an Ireland-based CDMO, pharmaceutical sponsors and biotech companies should evaluate the following:

  • Dosage form and molecule type: API synthesis, oral solid dose, sterile injectables, biologics, ATMP, and packaging are distinct specializations requiring specific facility types and regulatory licences.
  • Development stage alignment: Some Irish CDMOs specialize in early clinical supply; others are scaled for full commercial manufacturing. Match the CDMO's primary experience to your current programme phase.
  • Regulatory market access: Most Irish CDMOs hold dual FDA/EMA approval - but confirm coverage of all specific markets and regional regulatory authorities your product requires.
  • Potency and containment requirements: High-potency API programs require OEB-rated containment. Key options with OEB 4 capability in Ireland include EirGen Pharma (OSD), Hovione Cork (API), and Aenova Killorglin (oral solids).
  • Capacity and scheduling: With strong global demand for CDMO services in 2025–2026, begin conversations with potential partners early to align on project scheduling and manufacturing slot availability.

Ireland's pro-investment environment continues to attract substantial new CDMO capacity commitments. The pipeline of announced expansions - from EirGen's high-containment building to PCI's new injectable packaging hub to Almac's peptide synthesis facility - signals that the island's role in global pharmaceutical contract manufacturing will only grow through the remainder of this decade. For any sponsor or biotech evaluating a European CDMO strategy, Ireland deserves to be at the top of the shortlist.

Sources & Further Reading
  • IDA Ireland - Key players in Ireland's pharmaceutical manufacturing space (idaireland.com)
  • IPHA / Goodbody - The Pharmaceutical Sector in Ireland 2026
  • Hovione Press Room - Cork Site Expansion Announcements 2024–2025
  • Aenova Group - Killorglin Spray Drying Platform Launch, February 2025
  • Almac Group - New Commercial Manufacturing Facility Opening, March 2025
  • IDA Ireland - PCI Pharma Services: New CityNorth Facility Announcement
  • ATMP.ie - HiTech Health: GMP Cell & Gene Therapy Facility, Galway
  • Cambrex.com - Waterford, Ireland (Q1 Scientific) Site Profile
About the Author
Sreepriya Prasannan

Sreepriya Prasannan

Writer at Priya Life Science · Pharmaceutical

Sreepriya Prasannan is the Founder and Lead Editor of Priya Life Science. With a deep passion for the Irish pharmaceutical and MedTech sectors, she specializes in sharing actionable career insights, digital regulatory trends, and GMP compliance strategies.

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