Who we are - your outsourcing partner of choice

Alkermes Contract Pharma Services is a global business that provides product development scale-up and manufacturing services to the pharmaceutical market and is part of Alkermes plc. With over 40 years in the service business, we have assisted our blue chip list of partners in the successful launch of multiple products in more than 100 countries, including North America, Europe and Asia.

What we do

We have a long and successful history in the development and manufacture

of pharmaceutical dosage forms for pharmaceutical markets worldwide.

Product Development and Optimization

We have a wide range of development and optimization services to offer our

Partners. Our streamlined pathway to pharmaceutical dosage form development includes a Quality by Design (QbD) approach which allows

our teams to make intelligent decisions from analytical method development

right through to manufacturing process characterization.

Product Scale-up and Manufacturing

Our manufacturing group provides world-class current Good Manufacturing

Practices (cGMP) scale-up and manufacturing services for solid oral

dosage forms. Highly trained and experienced staff operate on a flexible

manufacturing schedule - up to 24 hours a day, 7 days a week in order to meet the demands of your product. Alkermes Contract Pharma Services

is driven by ‘excellence in everything we do’, which, through our integrated

Operational Excellence program, gives you the reassurance that your product

will be guided through our facilities to exacting specifications.

Key Benefits

Experience and Expertise:

- 40+ year history in business with strong track record

Industry Trust:

- 30+ leading Pharmaceutical Companies are partners of ours

FDA/EMA-Licensed Sites in both Europe and US

- including supply of product to Brazil, China and India.

Speed to Market:

- Capacity to design, build, commission, qualify and commercialize any solid oral process on-site

Compliant, Reliable and Cost Efficient Supplier

- Flexible infrastructure and efficient operations with mature Lean 6 Sigma/

Operational Excellence programs

Dedicated Customer Service:

- A dedicated project management resource will keep you informed at

all stages in the project/commercial supply arrangement

Access to Strategic Solutions to Extend Life of Your Product:

- Technology expertise including: Bioavailability Enhancement and Oral Controlled Release platforms

- Proven Life Cycle Management strategies

- Intellectual property portfolio of 1,500+ patents/applications and expertise

- Full CMC package capabilities for regulatory registration

Process Optimization Post-Launch:

- Small scale, reduced Active Pharmaceutical Ingredients (API) cost, material changes, additional strengths.

Proven Drug Technology Expertise:

- Proven drug optimization capabilities with 12 products developed and launched since 2001

Capabilities

Manufacturing and Development Capabilities
 At Alkermes Contract Pharma Services we have modern Solid Oral Dose Facilities to fit clients' precise product requirements, including:

• Milling
• Screening
• Blending
• Wet granulation (high shear and fluid bed) for solvent and aqueous processing
• Bead coating (organic solvent and aqueous based) using Wurster FBP, CF granulation and pans
• Tableting
• Film coating and sugar coating
• Encapsulation (powder, bead, dual fill)
• Controlled Substance manufacture
• Release testing - E.U. QP Service available for U.S. clients doing business in Europe
• Drug optimization

Packaging Capabilities
 Experienced staff skilled in areas of packaging, engineering and testing. We fulfill specific packaging requirements such as:

• Bottle filling and packaging
• Blister packaging – PVC, Foil
• Modern defect detection and rejection system
• Hand packaging to accommodate "special" presentations
• Artwork management

Contact Details

Alkermes Pharma Ireland Limited
 Monksland
 Athlone
 Co. Westmeath
 IRELAND

Contact Person: Philip Pratten
 Tel: +353 90 649 5590
 Mob/Cell: +353 86 0232273