Capabilities Overview

Four decades delivering contract pharma solutions for our partners

Alkermes Contract Pharma Services provides solid dosage form product development, scale-up and manufacturing services along with sterile fill-finish capabilities to the global pharmaceutical market. We have a long and successful history in the development and manufacture of pharmaceutical dosage forms for pharmaceutical markets worldwide. We have a blue chip list of partners and have assisted in the successful launch of multiple products in more than 100 countries in North America, Europe and Asia.

Extensive development, scale-up and manufacturing capabilities in U.S. and Europe

We offer a complete range of pharmaceutical development and manufacturing capabilities to support your requirements including effective, robust and swift tech transfers, a full selection of proven and validated technology and process improvement solutions including those for high potency product development and manufacturing, competitive pricing, on time delivery with an exceptional compliance track record in FDA/EMA licensed sites in U.S. and EU. Since we began pioneering drug development solutions for the pharma industry, over 40 years ago, we have assisted in the development and launch of over 40 products in the U.S. and International markets.

Modern facilities to fit partners’ precise product requirements

Alkermes Contract Pharma Services offers a significant advantage in outsourcing – a broad range of services and expertise integrated into one company – based in the U.S. and Europe. This approach reduces the need for technical transfers from product development and clinical trial suppliers to commercial manufacturing sites, enabling efficient scale-up from development to commercial production. By providing the whole process in this integrated manner, we have been able to recommend ways to improve production methods – reducing partner risk and also improving efficiencies.

Capabilities and facilities

  • Dedicated tech transfer, development, scale-up and commercial manufacturing capabilities
  • Modern facilities in Europe and U.S.
  • 2.5 billion units annually in solid oral dosage form manufacturing capacity
  • 10 million vials annually in aseptic sterile filling and finishing capacity
  • 2 million pre-filled syringe capacity by 2013
  • High potency product development, scale-up and manufacturing to < 0.1ug/M3
  • 470,000 sq ft of cGMP manufacturing facilities
  • Excellent quality and compliance record
  • Packaging facilities in the U.S. and Ireland
  • Mature infrastructure
  • DEA approved controlled substance manufacturing plant in U.S.
  • Development and manufacture of product for U.S., European, and Japanese markets as well as the emerging markets of India, China and Brazil

For more information on our range and depth of capabilities click here.

For more information on the integrated approach of our production model, click here.

pharmaceutical contract manufacturing Athlone, Ireland Facility

  • Located on 40 acres site, the facility has approximately 505,000 square feet of space
  • FDA/EMA licensed
  • The facility has an equipped annual capacity of 2 billion unit solid oral doses
  • High potency product development, scale-up and manufacturing

pharmaceutical contract manufacturing Gainesville, GA, U.S. Facility

  • Located on 148 acres of land, the facility has approximately 87,000 square feet of space
  • Includes 288 pallet vault built in accordance with DEA specifications
  • FDA/EMA/DEA licensed
  • The facility has an equipped capacity of 500 million unit solid oral doses

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