apimanufacturing

API Manufacturing

Targeting Breakthroughs for Niche Drug Products

PCI Synthesis offers customers a domestic source to turn to. PCI works in partnership to produce materials for our customers. PCI has the capacity to work with reactions from ml to 2000 gallons.

PCI Synthesis is a fully integrated Active Pharmaceutical Ingredient (API) supplier in partnership with our customers. PCI Synthesis offers a turnkey solution for all the steps needed to develop a final API, including process research, process development, analytical development, process validation, regulatory support, and FDA filing.

PCI Synthesis has numerous API products in its pipeline including generics and new chemical entities (NCE's) and will continue to launch and/or commercialize multiple APIs annually. PCI Synthesis targets API's for such therapeutic classes as anti-arrhythmic, anti-viral, anti-infective, and anti-depressant products. Typically, the API products we manufacture feature multi-step synthetic processing and are produced in volumes that range from tens or hundreds of kilograms to metric tons.

We consider speed to market our key service to the industry.

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