PCI Synthesis Submits Patent for Synthesizing Azelaic Acid

Posted: January 30, 2018

API Manufacturing and Pharmaceutical Manufacturing

Newburyport, Mass., Jan.  30, 2018 – PCI Synthesis, Inc., a pharmaceutical manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products, submitted a patent filing with the U.S. Patent and Trademark Office (USPTO) for a patent that covers an innovative process to synthesize Azelaic Acid as a drug substance.

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Azelaic Acid is used for producing industrial products including polyesters, plasticizers and lubricants and is a component in skin-care products but a large-scale synthesis for drug substance production remains challenging. PCI Synthesis began researching new synthetic processes because it recognized a need for a viable, cost-effective, efficient scale-up process for manufacturing high purity azelaic acid under cGMP conditions for use as an active pharmaceutical ingredient (API).

“Historically, Azelaic Acid was an API derived from an animal-based raw material and not well controlled from a GMP standpoint,”
said Ed Price, President of PCI Synthesis.

“Current material would not be approvable under the current paradigm of the FDA’s approval process. We have developed a novel multi-step, synthetic route that is manufactured completely under cGMP.  Therefore, our manufacturing process and analytical package meet all the latest FDA requirements for approval as a drug substance for an ANDA.”

About PCI Synthesis

PCI Synthesis is a Pharmaceutical Development CMO (Contract Manufacturing Organization) based in Newburyport, MA and is the largest small molecule drug substance manufacturer in the New England area. PCI is also a commercial manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products for the medical device industry.  As a contract manufacturing organization (CMO), PCI provides emerging and mid-sized pharmaceutical companies access to the expertise needed to develop and manufacture complex small molecules.
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Contact:

Linda Pendergast-Savage
Birnbach Communications
508-224-7905
lpendergastsavage@birnbachcom.com

About the Author

Ed Price CEO of PCI Synthesis
Ed is the President and CEO of PCI Synthesis (PCI), he serves as a co-chair of the New England CRO/CMO Council and sits on the Industrial Advisory Board for the Department of Chemical Engineering at UMass, Amherst. Ed is also a long standing member of the American Chemical Society and advises the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturer’s and Affiliates (SOCMA).

Do you have questions? Talk to Ed.