Small Molecules (API) manufacturing & Development

High-quality active pharmaceutical ingredients (API) via the development of a scalable process that will meet demand at each stage of your product’s life cycle. Complete drug product services from preformulation screening through clinical development to commercial supply. A comprehensive range of oral solid, sterile and softgel dosage forms with expertise in high-potency products. Unique solutions to overcome the toughest solubility challenges and accelerate your path to proof of concept.

Align the development and manufacture of your small molecule API and finished drug product with a world leader in both. In big ways and small, and at every stage, you’ll capture the advantages of fluid collaboration between our sites, teams and operations. You’ll unlock speed, quality and efficiency in ways not possible with any other CDMO.

Drug Substance

Patheon offers complete API services in Europe and North America. Capabilities that span a vast range of complex chemistries ensuring you’ll have the solution you need. A flexible process that enables rapid scalability for even the most difficult to manufacture discoveries. Quality ensured by comprehensive analytical services. A widely varied portfolio of generic APIs and excipients. An experienced project manager, multidisciplinary team and highly experienced regulatory support.

Product Development

Early development budgets and timelines are exceedingly tight. This pressures companies to do the bare minimum to get to clinical trials. It’s a viable early-stage strategy, but one prone to costly delays if later stages are not also kept in focus. Patheon takes a big-picture approach to small molecule product development that employs exceptional efficiency. Stay on budget and rapidly reach key development milestones while laying a scientifically sound foundation for late-clinical and commercial success.

Commercial Product Supply

A fully integrated global network of commercial manufacturing facilities. All with exceptional regulatory track records and pre-approvals from multiple agencies around the world. Capabilities across a comprehensive array of oral solid, sterile and softgel finished dosage forms. Scale-up and tech transfer processes that have won multiple international awards. Capacity at all scales, from small batches of specialized products to international supply of top sellers.

In Patheon, you’ll have a partner with more than 40 years of experience and a reputation for high-quality commercial product supply, built one successful project at a time. Between 2006 and 2015, we helped clients earn 92 overall NDA approvals, that’s nearly twice as many as the next ranked CMO. Last year alone we manufactured more than 700 products approved for more than 70 countries. With Patheon, you’ll have access to all the expertise, technologies and options you’ll need to succeed.

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