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Commercial Supply

Pharmaceutical companies are continually trying to bring more value and efficiency to their supply chain. With Patheon, you’ll be able to turn fixed costs into variable costs while maintaining long-term security of supply, superior quality and exceptional regulatory compliance. If you need commercial supply of your small molecule API, you’ll find no more flexible, capable and reliable strategic partner than Patheon.

Global Capacity: You’ll have access to industrial-scale facilities in the United States and Europe, some boasting total capacity in excess of 700,000 L with reactors as large as 16,000 L. If commercial supply on a global scale is what you need, you have found it.

Many Options: We offer an exceptionally broad range of services and capabilities encompassing the entire core of pharmaceutical chemistry and beyond, all in a cGMP environment. We have the resources and experience to manufacture APIs others found too difficult.

Relentless Innovation: Microreactor / flow chemistry at an industrial scale. Advanced catalysis with access to more than 2,000 enzymes. Process intensification technologies available nowhere else. Infrastructure and regulatory approvals to work with controlled substances and highly potent compounds such as cytotoxics. Everyday we are pushing the boundaries of what is possible to give our customers an edge.

Reliable Quality: Our exceptional regulatory track record, and Right First Time / On-Time performance have made Patheon #1 in the industry for quality.

Spotless Reputation: Patheon has earned the trust of the top 20 pharmaceutical companies in the world. We supply API for more than 100 commercial products.

A Seamless Transition

During early phases, your project will be based at one of our process development centers: ResCom® (Responsive and Committed) in Regensburg, Germany or our facility in Florence, SC, USA. Upon successful completion of early-stage clinical trials, it will transfer to one of our late-stage/commercial production facilities: Linz, Austria or Greenville, SC, USA. We maintain a tight alignment of teams and technologies between early and late phase sites to ensure that tech transfer and scale-up are as rapid and efficient as possible.

It doesn’t matter how unique or complex your process is, or how large your demand, or whether you have a new product or need to ensure the security of an established product’s commercial supply. With Patheon as your strategic partner you’ll have access to all the expertise, technologies and reliable quality you need to bring simplicity and peace of mind to your commercial supply.

The Best Solution for the Worst Situations

It takes a serious situation for a pharmaceutical company to make changes to the commercial supply of API for an established product: Persistent regulatory issues, fluctuations in quality, an outdated facility or the need for more capacity. Companies fear that switching will lead to market share eroding interruptions of supply, require expensive and time-consuming process revisions, and trigger regulatory hurdles. Make the move to Patheon, and make those risks all but disappear.

Your Team. Your Show: You will immediately be assigned a multidisciplinary team dedicated to your project’s success. All work and communication will be coordinated by a project manager with years of experience as well as deep scientific and technical knowledge. You will have all the transparency and access you need to drive your project forward on your terms.

Unrevised Process: We offer most all the technologies common in API manufacturing – plus others that are only available from Patheon. In most cases, we are able to run processes with minimal or no revision. That means rapid turnaround and no special regulatory filings.

Uninterrupted Supply: Tech transfers at Patheon have been recognized with international industry awards. We are quick, but we are also thorough in our completion of validation campaigns and stability studies. So depending upon your current situation, there’s no reason to anticipate an interruption of supply.

Want to be Sure? Call today to arrange a secondary supplier arrangement with Patheon. Once we are officially documented as a manufacturer for your product, everything will be in place for you to make changes at whatever pace your situation requires.

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