API Manufacturing

cGMP API Manufacturing

Where we offer three class 100,000 cGMP Suites for Pre-Clinical and Clinical Manufacturing and 23 Reactors with a total of 20,000 Gallons of API Manufacturing Capacity.

API Manufacturing and cGMP Polymer Manufacturing

At PCI, we understand the challenges in cGMP API manufacturing when you’re moving your project from the lab to the plant.

By the time your API synthesis is ready to be introduced into cGMP manufacturing a significant investment in both time and money has been expended.  Whether you’re looking to produce critical, clinical phase I-III trial material, material for commercial launch, or on-going API supply everything we do is geared toward making this final step as smooth and successful as possible.  The jump to cGMP manufacturing is never simple or easy.  Producing complex molecules within specification the first time in cGMP is fraught with potential peril at every turn.

That’s why we’ve built a seamless development solution that enables you to begin your active pharmaceutical ingredient development in our Devens R&D lab and then migrate it directly into our cGMP Newburyport API plant, where we offer up to 20,000 gallons of manufacturing capacity.  Because of our closely aligned R&D API synthesis and scale-up capabilities, you can feel confident in knowing that we’ll be with you all the way, from discovery to commercialization.

Every year, PCI puts more than a dozen new molecules into clinical trials for its sponsor companies and commercially supplies API’s to numerous major U.S. based generic pharmaceutical firms.  Whether your project requires large or small volumes PCI helps its partner companies’ succeed first with the FDA then in the marketplace, more than any other CMO in North America.

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