Capabilities Overview

Over 45 years of delivering contract pharma solutions for our partners

Alkermes Contract Pharma Services provides solid dosage 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 manufacture of pharmaceutical dosage forms for pharmaceutical markets worldwide. We are a chosen CMO to many of the largest pharma companies worldwide and have a blue chip list of partners where we have assisted them in the successful launch of multiple products in more than 100 countries in North America, Europe and Asia.

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

We offer a complete range of pharmaceutical manufacturing capabilities to support your requirements including effective, robust and swift tech transfers, a full selection of proven and validated process improvement solutions including those for high potency product manufacturing, competitive pricing, and on time delivery with an exceptional compliance track record in FDA/EMA licensed sites in U.S. and EU. Delivering on our services to exemplary quality standards is fundamental to our business. Since we began providing contract pharma solutions for the pharma industry, over 45 years ago, we have assisted in the 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. Our staff provides word-class Good Manufacturing Practices (cGMP) scale-up and manufacturing services to our partners. Highly trained and experienced staff operates on a flexible manufacturing schedule – up to 24 hours a day, 7 days a week in order to meet partner product demands. Our quality approach is exemplary with the most recent U.S. FDA audits across our operations sites resulting in no 483s. Our experience and expertise allows us to recommend ways to improve production methods – reducing partner risk and also improving efficiencies.

Capabilities and facilities

  • Dedicated tech transfer, 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
  • 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.
  • 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 process 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 annual capacity of 500 million unit solid oral doses

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A leader in pharmaceutical solid dosage form manufacture, providing reliable, high quality pharmaceutical manufacturing services. Check out our publications page for more information

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