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.
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.”
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.