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NEWBURYPORT, Mass., Jan. 30, 2018 (GLOBE NEWSWIRE) -- PCI Synthesis, Inc. (www.pcisynthesis.com), 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.”
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. To learn more about PCI Synthesis, its proprietary NCE development activities and process R&D capabilities please visit www.pcisynthesis.com.
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...