About DSM Pharmaceutical Products

Finished Dosage Forms

In the area of Finished Dosage Forms, DSM provides superior technical expertise and customer support.

DSM’s pharmaceutical dosage form manufacturing is centered in North Carolina. Its 1.5M square foot facility is located in 29 buildings on 640 acres. The way this site is engineered and operated makes it one of the world’s leading locations for the manufacture of aseptic liquid fill and lyophilized products and oral dosage forms, along with related services. DSM has invested over $130 million since 2001 to ensure the facility offers state-of-the-art technology, from production and quality processes to project management systems and regulatory support. One visit is typically enough to convince companies that DSM is the partner of choice.

We position Finished Dosage Forms alongside our Pharma Chemicals and Biologics businesses to provide an option of single source supply within the framework of cultural and product knowledge that encompasses a strategic partnership. Not only can we accomplish the entire process of active ingredient production --- from scale-up to commercial manufacturing --- but we can also achieve antibody and protein production through to dosage form manufacturing.

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Solid Dosage Forms

DSM offers custom manufacturing of Solid Dosage Forms in post-discovery and commercial phases. We have extensive knowledge and experience that combine with first-class capabilities to bring reassurance to customers. Capabilities include manufacture of tablets and capsules --- both instant and sustained-release --- for scheduled and non-scheduled drugs. More than 200,000 square feet of capacity at our facility is dedicated to solid form services, including:

•Blending, granulation, compression and encapsulation
•Coating
•Drying
•Printing, embossing and banding
•Bottle packaging
•Blister packaging
•Pouch / packet packaging
•Technology services

We have what it takes --- from highly experienced management and operational personnel to exceptional facilities and a first-class regulatory track record --- to optimize every customer’s project from start to finish.
 

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Sterile Dosage Forms

DSM offers comprehensive services and capabilities in sterile dosage form pharmaceuticals.
Our sterile capabilities are located in a dedicated world-class building. For aseptic liquid filling, we use a proprietary distributed control system on all lines. This flexible system controls SCADA, D3 and electronic cycle run-report functions in a single, unified solution.

For freeze-drying, lyophilizers range in size from 8 to 640 square feet and also feature proprietary software for cycle control. We can scale-up from an 8-square foot, non-cGMP unit to any commercial unit (up to 640 square feet) rapidly and efficiently.

DSM offers a variety of batch sizes, options for expanded development and analytical services, flexible scheduling, and routinely adapts our services to accommodate each customer’s individual expectations.

Cytotoxic formulation and filling
 services were a logical extension of our sterile form capabilities. Our facility earned Potent Compound Safety Certification from SafeBridge Consultants, Inc. This comprehensive profile of services and acknowledged quality further reinforce DSM’s qualifications as a strategic partner.

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Pharmaceutical Development Services

DSM offers pharmaceutical development services that bring added value to customers in terms of cost reduction and accelerated time to market.

With an average of 14 annual product launches and almost four decades of experience on site, we deliver whatever is needed to make customers successful. Teams of scientists and project managers at the facility are exclusively dedicated to providing customers with development services, including:

•Drug substance characterization
•Preformulation studies
•Formulation development
•Solid dosage clinical trial material manufacturing
•ICH / custom stability studies
•Evaluation of new delivery technologies
•Analytical method development / validation
•Lyophilization cycle optimization

Our full portfolio of services mean customers can avoid the expense of tech transfers leading to launch and commercial supply.

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Quality for Life™

Quality for Life™ is a commitment that consolidates DSM’s longstanding pledge to integrated risk management. It combines four interlinking pillars – quality, reliability, traceability, and an ongoing commitment to sustainability – values that are embedded into everyday routines. It was the first initiative of its kind to be introduced by an ingredient supplier, and provides an instantly recognizable seal of excellence that gives customers confidence.