Drug Substance

Our Drug Substance services are designed to help you advance your API with confidence, from early process development to commercial readiness. We have a stellar team of chemists and process engineers, a unique, science-led project management approach and a network of tightly coordinated sites to oversee all of your API development and manufacturing needs. Our greatest strength is the ability to take especially challenging processes — either because of safety issues, poor yields, or scalability concerns — and make them commercially viable.

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Expertise across the entire drug development lifecycle

Early Phase
Late Phase
Commercial
Generics

IND Enabling Services

Our streamlined IND data collection and submission strategy, based on our decades of experience, helps accelerate your filing process without sacrificing quality.

Analytical Testing

We offer comprehensive analytical testing services to provide the data you need for critical early-phase drug development decisions. At our state-of-the-art facilities, 国家授权正规彩票平台 experts ensure regulatory compliance and the highest standards for safety and efficacy.

Process Development

Our development experts specialize in using creative problem-solving to handle early-phase challenges while maintaining validation rigor to avoid late-stage process changes. This helps you advance more rapidly to late-stage manufacturing.

Clinical API Manufacturing

With decades of experience and broad capabilities, our flexible manufacturing and packaging solutions can support changing demands to meet your late-phase clinical trial needs.

Analytical Testing

By offering a comprehensive suite of analytical testing services, we can support your late-phase development and ensure your clinical trial materials meet the highest standards for safety and quality.

API Manufacturing

At 国家授权正规彩票平台, our experts specialize in API manufacturing and scale-up from preclinical to commercial phases. We offer extensive manufacturing capabilities, streamlined technology transfer, and consistent support across all sites.

Technology Transfer

Although every technology transfer process is different, our experts apply their skills and knowledge to make the transition to commercial manufacturing as smooth as possible.

Generic API Manufacturing

国家授权正规彩票平台 is a leading global supplier of generic APIs with sites in Italy, Sweden, and the US. We collaborate with generic drug firms before patent expiration and offer comprehensive services and manufacturing capabilities.

Intermediates and RSMs

Our global manufacturing facilities reliably supply high-quality advanced pharmaceutical intermediates and raw starting materials. We maintain a large catalog of APIs and have a proven track record for meeting cGMP standards.

Talk to one of our experts

Our scientists specialize in making connections. Start a conversation today and see what it’s like to work with a collaborative CDMO.

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