Who we are - your outsourcing partner of choice
Alkermes Contract Pharma Services 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 as well as sterile filling and finishing. We also have the capability to handle and manufacture highly potent compounds.
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.
Experience and Expertise:
- 40+ year history in business with strong track record
- 30+ leading Pharmaceutical Companies are partners of ours
FDA/EMA-Licensed Sites in both Europe and U.S.
- 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 including highly potent compounds
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
- Full CMC package capabilities for regulatory registration
Process Optimization Post-Launch:
- Small scale, material changes, additional strengths.
Proven Drug Technology Expertise:
- Proven drug optimization capabilities with 12 products developed and launched since 2001
Manufacturing and Development Capabilities
At Alkermes Contract Pharma Services we have modern solid oral dose and sterile powder/liquid facilities to fit clients' precise product requirements, including:
Experienced staff skilled in areas of packaging, engineering and testing. We fulfil specific packaging requirements such as:
Alkermes Pharma Ireland Limited